Iso 16142-2-2017

INTERNATIONAL ISO
STANDARD 16142-2
First edition
2017-08
Medical devices — Recognized

essential principles of safety and
performance of medical devices —
Part 2:
General essential principles and
additional specific essential principles
for all IVD medical devices and
guidance on the selection of standards
Dispositifs médicaux — Principes essentiels reconnus de sécurité et de
performance des dispositifs médicaux —
Partie 2: Principes essentiels généraux et principes essentiels
spécifiques supplémentaires pour tous les dispositi fs médicaux de DIV
et directives sur le choix des normes
Reference number
ISO 16142-2:2017(E)
© ISO 2017
ISO 16142-2:2017(E)
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ii © ISO 2017 – All rights reserved

ISO 16142-2:2017(E)
Contents Page
Foreword .................................................. ................................................... ................................................... ................................................... ............................. iv
Introduction .................................................. ................................................... ................................................... ................................................... ....................... v
1 Scope .................................................. ................................................... ................................................... ................................................... ...................... 1
2 Normative references .................................................. ................................................... ................................................... .............................. 1
3 Terms and definitions .................................................. ................................................... ................................................... ............................. 4
4 Essential principles of safety and performance of IVD medical devices .................................................. .. 8
5 Use of standards and guides in support of the essential principles .................................................. ............. 8
5.1 General approach to using standards .................................................. ................................................... ............................. 8
5.2 Types o f standards use ful to demonstrate compliance .................................................. ..................................... 9
5.3 Risk management approach to demonstrating compliance .................................................. ....................... 10
5.4 Phases o f the IVD medical device li fe-cycle .................................................. ................................................... ............ 11
5.5 Use o f standards during IVD medical device li fe-cycle phases .................................................. ................. 11
5.5.1 Design and development planning .................................................. ................................................... ........... 11
5.5.2 Design and development including testing and validation .................................................. .... 12
5.5.3 Regulatory premarket review ................................................... ................................................... ..................... 12
5.5.4 Production .................................................. ................................................... ................................................... .................. 12
5.5.5 Post-production including IVD medical device use and post-
market surveillance .................................................. ................................................... ............................................... 12
5.5.6 End of life .................................................. ................................................... ................................................... ..................... 12
5.6 Assessing the con formity o f an IVD medical device ................................................... ......................................... 13
6 Essential principles and references to relevant standards and guides .................................................. .. 13
6.1 Use o f standards by authorities having jurisdiction .................................................. .......................................... 13
6.2
Manufacturers’ use of essential principles and references to relevant standards
or guides .................................................. ................................................... ................................................... ............................................ 14
Annex A (informative) Rationale and guidance .................................................. ................................................... ................................ 15
Annex B (normative) Table relating essential principles to standards ................................................... ..................... 17
Annex C (informative) Website listings of other standards suitable for the medical device
sector and for assessment purposes ................................................... ................................................... ....................................... 34
Annex D (informative) Reference to the essential principles by International Standards ....................... 35
Annex E (informative) Terminology — Alphabetized index o f defined terms .................................................. ..... 40
Bibliography .................................................. ................................................... ................................................... ................................................... .................. 41
© ISO 2017 – All rights reserved iii

ISO 16142-2:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work o f preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
di fferent types o f ISO documents should be noted. This document was dra fted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f
patent rights. ISO shall not be held responsible for identi fying any or all such patent rights. Details o f
any patent rights identified during the development o f the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is in formation given for the convenience o f users and does not
constitute an endorsement.
For an explanation on the voluntary nature o f standards, the meaning o f ISO specific terms and
expressions related to con formity assessment, as well as in formation about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html .
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correspon din g gen eral aspects for m edical devices
This document builds on ISO 16142-1, which cancels and replaces ISO/TR 16142:2006.
A list of all parts in the ISO 16142 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

ISO 16142-2:2017(E)
Introduction
Standard s a nd s tanda rd i z ation pro ce s s e s c an be made more e ffe c tive by developi ng a b e tter
u nders ta nd i ng o f the ne e d s a nd re qu i rements o f tho s e who u s e or who a re a ffe c te d by s ta nda rd s .
Improvements in standards will contribute to global harmonization efforts at all levels.

C onti nuou s i n novation i s key to the advancement o f me d ic a l device te ch nolo g y, contributi ng to more
e ffe c tive he a lthc are . I de a l ly, s tandard s s upp or ti ng or re ference d in re gu l ator y re qu i rements are
develop e d a nd appl ie d i n s uch a way a s to a l low pro duc t i n novation b y i ndu s tr y wh i le a s s uri ng s a fe ty
and effectiveness.
T he ti mely development o f me d ica l device s tanda rd s and thei r p erio d ic revi s ion ma ke me d ic a l device
s tand ard s e ffe c tive and e fficient to ol s for s upp or ti ng regu lator y s ys tem s and for ach ievi ng glob a l ly
compatible regulation.
Volu ntar y s tandard s and gu ide s c an as s i s t manu fac tu rers to comply with lega l re qu i rements . I f the
s tand ard s a re accep te d with i n a given regu lator y s ys tem, compl ia nce with s uch s tandard s ca n be
de eme d to s ati s fy the le ga l re qui rements . T he regu lator y accep ta nce do es no t, o f its el f, i mply that s uch
s tand ard s are mandator y.
Medical device standards represent a consensus on requirements that foster innovation while
protecting public health.
H armon i ze d compl ia nce with the regu lation s , a key element o f ti mely marke t i ntro duc tion o f adva nce
te ch nolo g y, c a n b e faci l itate d by the appropriate u s e o f relevant me d ic a l device s tand ard s . T h i s i s b as e d
on the premise that

— standards are based on experience or, in other words, are retrospective,
— innovation can present unanticipated challenges to experience,
— rigid, mandator y, appl ic ation o f s tandard s c a n de ter i nnovation,
— op eration o f a qua l ity management s ys tem, s ubj e c t to a s s e s s ment, has b e come widely acknowle dge d
as a fundamental and effective tool for the protection of public health,

— qua l ity management s ys tem s i nclude provi s ion s th at add re s s b o th i n novation a nd exp erience, a nd
— s uch provi s ion s o f qua l ity ma nagement s ys tem s i nclude field exp erience, ri s k a na lys i s and ri sk
management, phased reviews, documentation and record keeping, as well as the use of product and
process standards.
T he e s s enti a l pri nciple s o f s a fe ty a nd p er formance o f me d ic a l device s were origi na l ly develop e d b y the
Glob a l H armon i z ation Tas k Force (GH T F ) , revi s e d i n 2 01 2 to h armoni z e regu lator y re qui rements for
me d ic a l device s worldwide, a nd now a rch ive d b y the I nternationa l M e d ica l D evice Regu lators Foru m
(IMDRF). Thus, an update of the original ISO/TR 16142:2006, based on those essential principles, was
needed to keep the document in line with the updated essential principles.
In discussing the revision of ISO/TR 16142:2006, ISO/TC 210 decided that the information included
was, at the time of writing, in a state of consensus between the stakeholders and had matured enough
to elevate the document from a Technical Report (TR) to an International Standard.
I n th i s do c ument, the fol lowi ng pri nt typ e s are u s e d:
— re qu i rements and defi nition s: roman typ e;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
typ e . Normative te x t o f table s i s a l s o i n a s ma l ler typ e;
— term s defi ne d i n Clause 3: italics.
© ISO 2017 – All rights reserved v

ISO 1 61 42 -2 : 2 01 7(E)
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true i f any
combination of the conditions is true.
For the purposes o f this document, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document,
— “may” is used to describe a permissible way to achieve compliance with a requirement or test, and
— “must” is used to describe an external constraint, but is not mandatory for compliance with this
document.
An asterisk (*) as the first character o f a title or at the beginning o f a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
vi © ISO 2017 – All rights reserved

INTERNATIONAL STANDARD ISO 16142-2:2017(E)
Medical devices — Recognized essential principles of

safety and performance of medical devices —
Part 2:
General essential principles and additional specific
essential principles for all IVD medical devices and
guidance on the selection of standards
1 Scope
T h i s do c u ment, wh ich i nclude s the e s s enti a l pri nciple s o f s a fe ty and p er formance, identi fie s s igni fica nt
s tand ard s a nd gu ide s th at c a n b e u s e d i n the as s es s ment o f con form ity o f a me d ica l device to the
recognized essential principles that when met, indicate a medical device is safe and performs as
i ntende d . T his do c u ment identi fie s and de s crib e s the f f
s i x genera l e s s enti a l pri nciple s o s a e ty a nd
performance (see Table B.1 ) th at apply to a l l me d ic a l device s , i nclud i ng I VD me d ica l device s (in vitro
diagnostic).
This do c ument also identi fies a nd de s crib e s the add itiona l e s s enti a l pri nciple s of s a fe ty and
performance which need to be considered during the design and manufacturing process, which are
relevant to IVD medical devices.
NOTE During the design process, the manufacturer selects which of the listed design and manufacturing
pr i nc ip le s app l y to the p a r tic u l a r me d ic a l de vice a nd do c u ments the re a s o n s for e xclud i n g o thers .
T h i s do c ument i s i ntende d for u s e a s gu id ance b y me d ic a l device ma nu fac tu rers , s tandard s development
organ i z ation s , authoritie s havi ng j uri s d ic tion, a nd con form ity as s e s s ment b o d ie s .
2 Normative references
T he fol lowi ng do c uments a re re ferre d to i n the te x t i n s uch a way that s ome or a l l o f thei r content
con s titute s re qu i rements o f th i s do c u ment. For date d re ference s , on ly the e d ition cite d appl ie s . For
u ndate d re ference s , the late s t e d ition o f the re ference d do c ument (i nclud i ng a ny amend ments) appl ie s .
ISO 2859 (all parts), Samplin g procedures for in spection by attributes
ISO 3951 (all parts), Samplin g procedures for in spection by variables
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation an d routin e control of a sterilization process for m edical devices
ISO 11137 (all parts), Sterilization of h ealth care products — Radiation
ISO 11138 (all parts), Sterilization of h ealth care products — Biological in dicators
ISO 11140 (all parts), Sterilization of h ealth care products — Ch emical in dicators
ISO 11607 (all parts), Packagin g for term in ally sterilized m edical devices
ISO 11737 (all parts), Sterilization of m edical devices — Microbiological m eth ods
ISO/TS 13004, Sterilization of h ealth care products — Radiation — Substantiation of selected sterilization
dose: Method VDmaxSD
ISO 13408 (all parts), A septic processin g of h ealth care products
© ISO 2017 – All rights reserved 1

ISO 1 61 42 -2 : 2 01 7(E)
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14161, Sterilization of health care products — Biological indicators — Guidance for the selection, use
an d interpretation of results
ISO 14644 (all parts), Clean room s an d associated controlled en vironm ents
ISO 14698 (all parts), Cleanroom s an d associated controlled environm ents — Biocontam in ation control
ISO 14937, Sterilization ofhealth care products — General requirements for characterization ofa sterilizing
agent and the development, validation and routine control o f a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk m an agem ent to m edical devices
ISO 15193, In vitro diagnostic medical devices — Measurement o f quantities in samples o f biological
origin — Requirements for content and presentation o f re ference measurement procedures
ISO 15194, In vitro diagnostic medical devices — Measurement o f quantities in samples o f biological
origin — Requirements for certified re ference materials and the content o f supporting documentation
ISO 15195, Laboratory medicine — Requirements for reference measurement laboratories

ISO 15197, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-
testin g in m an agin g diabetes m ellitus
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and in formation to
be supplied — Part 1: General requirements
ISO 15882, Sterilization of health care products — Chemical indicators — Guidance for selection, use and
interpretation of results
ISO 16269 (all parts),

Statistical interpretation of data
ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values assign ed to calibrators an d control m aterials
ISO 17593, Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring
system s for self-testin g of oral anticoagulant th erapy
ISO 17665 (all parts), Sterilization of h ealth care products — Moist h eat
ISO 18113 (all parts), In vitro diagnostic medical devices — In formation supplied by the manu facturer
(labellin g)
ISO 18153, In vitro diagnostic medical devices — Measurement o f quantities in biological samples —
Metrological traceability of values for catalytic con centration of en zym es assign ed calibrators an d control
m aterials
ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment
ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development,
validation an d routin e control of a sterilization process for m edical devices
ISO 22442 (all parts), Medical devices utilizin g anim al tissues an d th eir derivatives
ISO 23640, In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
ISO/TR 24971, Medical devices — Guidance on the application of ISO 14971
ISO 25424, Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements
for development, validation and routine control o f a sterilization process for medical devices
ISO/IEC 15026 (all parts), System s an d software en gin eerin g — System s an d software assuran ce
2 © ISO 2017 – All rights reserved

ISO 1 61 42 -2 : 2 01 7(E)
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
ISO/IEEE 11073 (all parts), Health informatics — Personal health device communication
CLSI EP05 1) , Evaluation of precision of quantitative measurement procedures; Approved guideline
CLSI EP061) , Evaluation of the linearity of quantitative measurement procedures: a statistical approach;
Approved guideline
CLSI EP07 1) , Interference testing in clinical chemistry; Approved guideline
CLSI EP12-A2 1) , User protocol for evaluation of qualitative test performance; Approved guideline
CLSI EP26-A 1) , User evaluation of between-reagent lot variation; Approved guideline
CLSI POCT12 1) , Human point-o f-care blood glucose testing in acute and chronic care facilities; Approved
guideline
AAMI HE75, Human factors engineering — Design of medical devices
ASTM F2027, Standard guide for characterization and testing of raw or starting biomaterials for tissue-
engineered medical products
ASTM F2761, Medical devices and medical systems — Essential sa fety requirements for equipment
comprising the patient-centric integrated clinical environment (ICE) — Part 1: General requirements and
conceptual model
EN 13532, General requirements for in vitro diagnostic medical devices for self-testing
EN 13612, Performance evaluation of in vitro diagnostic medical devices
EN 13641, Elimination or reduction of risk of infection related to in vitro diagnostic reagents
EN 14136, Use of external quality assessment schemes in the assessment of the performance of in vitro
diagnostic examination procedures
IEC 60068, Environmental testing
IEC 60812, Analysis techniques for system reliability — Procedure for failure mode and effects analysis (FMEA)
IEC 60825 (all parts), Safety of laser products
IEC 60878, Graphical symbols for electrical equipment in medical practice
IEC 61010-2-101, Sa fety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6, Electrical equipment for measurement, control and laboratory use — EMC requirements —
Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment
IEC 62304, Medical device software — Software life cycle processes

IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 62366-2, Medical devices — Part 2: Guidance on the application ofusability engineering to medical devices
IEC 62471, Photobiological safety of lamps and lamp systems
IEC/ISO 80000 (all parts), Quantities and units
IEC/ISO 80001-1, Application of risk management for IT-networks incorporating medical devices — Part 1 :
Roles, responsibilities and activities
1) Available from: Clinical and Laboratory Standards Institute, Wayne, PA US.

ISO 16142-2:2017(E)
IEC/TR 80001-2-1, Application of risk management for IT-networks incorporating medical devices — Part
2-1 : Step by step risk management o f medical IT-networks — Practical applications and examples
IEC/TR 80001-2-5, Application of risk management for IT-networks incorporating medical devices — Part
2-5: Application guidan ce — Guidan ce on distributed alarm system s
IEC/ISO 80002-1, Medical device so ftware — Part 1: Guidance on the application of ISO 14971 to medical
device software
3 Terms and definitions

For the pu rp o s e s o f th i s do c u ment, the fol lowi ng term s a nd defi n ition s apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
N o te Fo r conven ience , the s ou rce s o f a l l de fi ne d term s u s e d i n th i s do c u ment a re gi ven i n Annex E.
3.1
authority having jurisdiction
regulatory authority
govern menta l agenc y or o ffice a s s igne d to overs e e the regu lation o f a re gu late d pro duc t with i n a
cou ntr y, j u ri s d ic tion, or a s s igne d territor y
3.2
basic standard
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i rements with re gard to
general aspects applicable to a wide range of products, processes or services

N o te 1 to entr y: B a s ic s ta nd a rd s a re s o me ti me s re fer re d to a s hor i z o nta l s ta nda rd s a nd u s u a l l y app l y to mo re
th a n one field (s e c to r) .
3.3
essential principles
essential principles of safety and performance
fundamental high-level requirements that when complied with ensure a m edical device (3.13) is safe
and performs as intended
3.4
group standard
basic stan dard (3.2 ) that s p e ci fie s s a fe ty a nd p er formance re qu i rements appl icable to s evera l or a
fam i ly o f s i m i la r pro duc ts , pro ce s s e s or s er vice s
N o te 1 to entr y: Group s ta nd a rd s a re s o me ti me s re fer re d to a s s em i- ho ri z o nta l s ta nd a rd s a nd u s u a l l y app l y to
one field (s e c tor) .
3.5
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.6
hazardous situation
ci rcu m s tance i n wh ich p e ople, prop er ty, or the envi ron ment is/are exposed to one or more hazards (3.5)

ISO 16142-2:2017(E)
3.7
informative
providing useful or interesting information
Note 1 to entry: Not required for compliance.
3.8
intended use
use for which a product, process or service is intended according to the specifications, instructions and
in formation provided by the m anufacturer (3.12)
[SOURCE: ISO 14971:2007, 2.5]
3.9
IVD kit
IVD medical device kit
set o f reactive components that are packaged together and intended to be used to per form a specific
IVD examination
Note 1 to entry: IVD kit components can include reagents (such as antibodies, enzymes, bu ffer and diluents),
calibrators, controls and other articles and materials.
[SOURCE: ISO 18113-1:2009, 3.32, modified]
3.10
in vitro diagnostic medical device
* IVD medical device
(3.13 ) intended by the m anufacturer (3.12) for the examination of specimens derived
m edical device
rom the human body to provide in formation for diagnostic, monitoring or compatibility purposes
f
EXAMPLE Reagents, calibrators, specimen collection and storage devices, control materials and related
instruments, apparatus or articles.
Note 1 to entry: An IVD medical device can be used alone or in combination with accessories or other medical
devices.
[SOURCE: ISO 14971:2007, 2.6, modified]
3.11
life-cycle
all phases in the life of a m edical device (3.13 ), from the initial conception to final decommissioning and
disposal
[SOURCE: ISO 14971:2007, 2.7]
3.12
manufacturer
natural or legal person with responsibility for the design, manu facture, packaging, or labelling o f a
m edical device(3.13 ), assembling a system, or adapting a m edical device (3.13) before it is placed on the
market or put into service, regardless o f whether these operations are carried out by that person or on
that person's behal f by a third party
Note 1 to entry: Attention is drawn to the fact that the provisions o f national or regional regulations can apply to
the definition o f manu facturer.
Note 2 to entry: For a definition o f labelling, see ISO 13485:2016, 3.8.
[SOURCE: ISO 14971:2007, 2.8]

ISO 16142-2:2017(E)
3.13
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
so ftware, material or other similar or related article, intended by the m anufacturer (3.12) to be used,
alone or in combination, for human beings for one or more o f the specific purpose(s) o f
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation o f or compensation for an injury,
— investigation, replacement, modification, or support o f the anatomy or o f a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,
— providing in formation for medical purposes by means o f in vitro examination of specimens derived
from the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.
Note 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF) [5] .
Note 2 to entry: Products, which could be considered to be medical devices in some jurisdictions but for which
there is not yet a harmonized approach, are:
— aids for disabled/handicapped people,
— devices for theGet
treatment/diagnosis o f diseases
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— accessories for medical devices (see Note 3),
— disinfection substances,
— devices incorporating animal and human tissues which can meet the requirements o f the above definition
but are subject to di fferent controls.
Note 3 to entry: Accessories intended specifically by manu facturers to be used together with a parent medical
device to enable that medical device to achieve its
in ten ded use (3.9 ) should be subject to this document.
[SOURCE: ISO 14971:2007, 2.9, modified — The word “intended purpose” has been changed to
“intended use”.]
3.14
normative
providing required information
Note 1 to entry: Required for compliance.
3.15
performance evaluation
investigation of a device intended to become an IVD medical device (3.10) for the purpose of establishing
or veri fying its per formance claims
[SOURCE: ISO 18113-1:2009, 3.52]

ISO 16142-2:2017(E)
3.16
process standard
standard that specifies requirements for elements o f a process used to develop, implement or maintain
a stage of the life-cycle (3.11) of a product or service
Note 1 to entry: A process standard may be a ba sic stan dard (3.2), group stan dard (3.4) or product stan dard (3.17).
3.17
product standard
standard that specifies necessary sa fety and per formance requirements for a specific or a family o f
product(s), process(es), or service(s) making reference, as far as possible, to basic stan dards (3.2) and
group stan dards(3.4)
Note 1 to entry: Product standards are sometimes re ferred to as vertical standards.
3.18
post-production
part of the (3.11) of the product after the design has been completed and the
life-cycle m edical device
(3.13) has been manufactured

EXAMPLE Transportation, storage, installation, product use, maintenance, repair, product changes,
decommissioning and disposal.
[SOURCE: ISO 14971:2007, 2.11]
3.19
residual risk
risk (3.20) remaining after risk control (3.21) measures have been taken
Note 1 to entry: Adapted from ISO/IEC Guide 51:2014, 3.9.
Note 2 to entry: ISO/IEC Guide 51:2014, 3.9 uses the term “protective measures” rather than “risk control
measures.” However, in the context o f this document, “protective measures” are only one option for controlling
risk as described in 6.2.
[SOURCE: ISO 14971:2007, 2.15]
3.20
risk
combination o f the probability o f occurrence o f harm and the severity o f that harm
3.21
risk control
process in which decisions are made and measures implemented by which risks (3.20) are reduced to,
or maintained within, specified levels
[SOURCE: ISO 14971:2007, 2.19]
3.22
risk management
systematic application o f management policies, procedures and practices to the tasks o f analysing,
evaluating, controlling and monitoring risk (3.20)
[SOURCE: ISO 14971:2007, 2.22]
3.23
state of the art
developed stage o f technical capability at a given time as regards products, processes and services,
based on the relevant consolidated findings o f science, technology and experience
ISO 16142-2:2017(E)
4 Essential principles of safety and performance of IVD medical devices

IVD medical device standards developers are encouraged to consider the essential principles as design
input for the development of new and revised IVD medical device standards. Additional information is
found in Annex D.
IVD medical device performance can include technical functions in addition to clinical effectiveness.
Per formance is easier to objectively measure and quanti fy than clinical e ffectiveness. Per formance
may be described as how well or accurately an IVD medical device carries out its use(s) as intended by
its manu facturer. For some IVD medical devices, medical benefit or clinical e ffectiveness can only be
determined by conducting clinical per formance studies carried out in human subjects.
The manufacturer of an IVD medical device is expected to design and manufacture a product that is
sa fe and clinically e ffective throughout its li fe-cycle. This document describes fundamental design and
manu facturing criteria, re ferred to as essential principles o f sa fety and per formance, to ensure this
outcome. This document is structured to provide general essential principles that apply to all medical
devices including IVD medical devices. This document also includes additional essential principles of
sa fety and per formance which are relevant to IVD medical devices that need to be considered during
the design and manufacturing process.
Essential principles o f sa fety and per formance provide broad, high-level, criteria for design, production
and post-production (including post-market surveillance) throughout the li fe-cycle o f all IVD medical
devices, ensuring their sa fety and per formance. The concept o f essential principles was developed
by Study Group 1 o f the Global Harmonization Task Force [5] . The concept is intended to encourage
convergence in the evolution o f regulatory systems for IVD medical devices.
NOTE Some authorities having jurisdiction have more requirements and some have less. There fore,
manu facturers need to understand the requirements o f the authorities having jurisdiction in the markets they
intend to serve.
Where relevant, to ensure all o f the essential principles are met, a manu facturer may use consensus
standards that contain detailed requirements demonstrating conformance with the essential principles.
Such consensus standards provide a greater level o f detail and specificity than can be expressed in the
essential principles. Equally, authorities having jurisdiction may find the essential principles and their
related standards use ful in the fulfilment o f premarket and post-market requirements throughout the
li fe-cycle o f IVD medical devices.
Every IVD medical device has a use as intended by its manu facturer. An IVD medical device is clinically
e ffective when it provides accurate and reliable in formation for diagnostic, monitoring or compatibility
purposes in a sa fe manner as intended by its manu facturer relative to
— the medical condition of the patient, or
— the state of the patient
where the medical benefits o f the use o f the IVD medical device outweighs the risk o f the use to the
patient.
5 Use of standards and guides in support of the essential principles
5.1 General approach to using standards

The essential principles o f sa fety and per formance are the general, high-level criteria that when met
indicate that an IVD medical device is sa fe and e ffective. Regulatory requirements expect that an IVD
medical device be sa fe and e ffective during its li fe-cycle and so con formity with the essential principles
o f sa fety and per formance must be achieved throughout the li fe-cycle o f the IVD medical device.

ISO 16142-2:2017(E)
For the IVD medical device manu facturer, this usually means that their IVD medical device complies
with the essential principles and must be
a) designed to be safe and effective,
b) manufactured to maintain the design characteristics,
c) used in a way that maintains the design characteristics, and
d) in the post-production phase, reviewed to evaluate the production and post-production information
for relevancy to sa fety and per formance, in which case, a design change might be needed to make
the IVD medical device compliant again with the essential principles.
It is important to note that it is not possible to ensure an acceptable level o f sa fety and per formance
in the li fe-cycle by simply being compliant with one or more standards at one time. A process for
continuous compliance is required and the expectation is that this is achieved through the use of a
quality management system and a risk management process (this is addressed in the general essential
principles, 1 to 6, although the word risk management is not used there).
5.2 Types of standards useful to demonstrate compliance
Basic standards, group standards, product standards and process standards are the four types o f
consensus standards, any o f which can be normative. Figure 1 illustrates the relationships between
these types o f standards. Because basic standards are so broad that they cross multiple sectors as noted
in the examples below, it is rare, if ever, that basic standards are used in the medical device sector.
EXAMPLE 1 Management system standard (ISO 9001).
EXAMPLE 2 Environmental management system standard (ISO 14001).
EXAMPLE 3 Risk management standard (ISO 31000).
EXAMPLE 4 Con formity assessment standard (ISO/IEC 17000).
The majority o f medical device consensus standards fall within the group standard and product
standard types. While process standards are widely used in the medical device sector, they are
subtypes o f group standards and product standards.
Group standards are generally horizontal in nature within the medical device sector and are developed
to address the essential principles that are applicable to a wide range of medical devices. Examples
o f group standards include sa fety standards or standards speci fying requirements for a process, such
as biological evaluation, general requirements for basic sa fety and essential per formance for medical
electrical equipment, sterilization and usability.

ISO 16142-2:2017(E)
Figure 1 — Types of standards

P ro duc t s tand ard s a re typic a l ly ver tic a l i n natu re and provide the te ch n ica l de ta i l s ne e de d to s ati s fy
compl i ance with the e s s enti a l pri nciple s for p a r tic u lar pro duc t typ e s . E xample s o f pro duc t s tandard s
include standards for blood glucose test strips and meter. The development and use of international
product standards is encouraged as this minimizes the proliferation of regional standards and prevents
the development o f d ivergent or con fl ic ti ng re qui rements or exp e c tation s .
Process standards can be either horizontal or vertical in nature and provide the requirements for
manu fac tu rers to develop , i mplement a nd ma i nta i n pro ce s s e s appl ic able to a l l s tage s o f the l i fe - c ycle
o f a me d ic a l device . Qua l ity management s ys tem s tand ard s and ri s k management s ta ndard s are go o d
example s o f pro ce s s s tanda rd s with i n the group s tandard s typ e . O p eration or mai ntenance o f blo o d
gluco s e mon itori ng s ys tem s i s a go o d example o f a pro ce s s s tanda rd with i n the pro duc t s tandard s
typ e . B e c au s e the fo c u s c a n ch ange at variou s p oi nts with i n the l i fe - c ycle o f a ny given me d ic a l device,
pro ce s s s tandard s a re routi nely develop e d b o th a s group o r pro duc t s ta nda rd s .
5.3 Risk management approach to demonstrating compliance

T he fi rs t s i x e s s enti a l pri nc iple s are genera l and provide the criteria for ri sk ma nagement and are
delineated in Table B.1. The rest of the essential principles, the design and manufacturing essential
principles, can be viewed from a risk management perspective.
G eneric a l ly, the de s ign and ma nu fac tu ri ng e s s entia l pri nciple s identi fy a genera l ha z ard a nd the
exp e c ta nc y o f e ach c an d i ffer as:
— the e s s entia l pri nciple s identi fy the genera l as p e c ts th at the s e quence or combi nation s o f events
le ad i ng to h a z ardou s s ituation s are identi fie d a nd control le d i f ne ce s s ar y;
— the e s s entia l pri nc iple s identi fy a h a z ardou s s ituation a nd re qu i re that the s e quence or combi nation
o f events le ad i ng to the ha z ardou s s ituation a re identi fie d and the ri s k i s control le d i f ne ce s s a r y;
— the e s s entia l pri nciple s d i re c tly identi fy a ri s k control me a s ure to b e u s e d to control the ri s k.

ISO 16142-2:2017(E)
5.4 Phases of the IVD medical device life-cycle

T he me d ic a l device l i fe - c ycle i nclude s all pha s e s in the l i fe of a me d ic a l device, from the i n itia l
concep tion to fi na l de com m i s s ion i ng and d i s p o s a l . D u ri ng the me d ic a l device l i fe - c ycle, either pro ce s s
or pro duc t s tandard s may b e u s e d to fu l fi l e s s enti a l pri nc iple s . Figure 2 depic ts a s ample l i fe - c ycle o f a
me d ic a l device, i nclud i ng e xa mple s o f I nternationa l Standard s that may b e uti l i ze d du ri ng the d i s ti nc t
pha s e s o f the l i fe - c ycle to me e t the e s s enti a l pri nc iple s , and p a ra l lel pro ce s s s ta nda rd s with d i s ti nc t
ac tivitie s as s o c iate d with e ach o f the l i fe - c ycle phas e s .
P ro duc t s ta nda rd s genera l ly defi ne s p e c i fic te ch n ic a l s olution s to e s s entia l pri nciple s a nd are appl ie d
mai n ly du ri ng I VD me d ic a l device de s ign a s p o s s ible te ch n ic a l s olution s to es s entia l pri nc iple s . T ho s e
s tandard s genera l ly defi ne re qu i rements wh ich, when i mplemente d, provide ri sk control me as u re s to
known hazards or hazardous situations.

I n add ition, pro ce s s s tandard s de tai l re qu i rements for pro ce s s e s , wh ich exi s t conti nuou sly du ri ng the
pha s e s o f a me d ica l device l i fe - c ycle . T he s e s ta ndard s manage as p e c ts o f the me d ic a l device s a fe ty and
performance as intended and thus, assist the manufacturer in implementing the essential principles.
EXAMPLE 1 ISO 13485.
EXAMPLE 2 ISO 14971.
Figure 2 — Phases of the life-cycle
5.5 Use of standards during IVD medical device life-cycle phases
5.5.1 Design and development planning
If a standard is intended to be used to demonstrate compliance with one or more essential principles,
the re qui rements o f the s ta nda rd b e come re qu i rements
f or the I VD me d ic a l device i n the e arly s tage s
of the design process.

S evera l pro ce s s s tandard s , s uch as I S O 149 71 on ri s k management, I S O 1 3 4 8 5 on qua l ity ma nagement
s ys tem s , I E C 62 3 6 6 -1 on u s abi l ity and I E C 62 3 0 4 on s o ftware l i fe - c ycle pro ce s s e s re qui re that pl an s

ISO 16142-2:2017(E)
are developed for each of those topics during the initial IVD medical device design and development
planning.
NOTE Although this document does not apply to IVD medical device, manu facturers can find use ful
information in IEC 60601-1-9 [12] on environmental impact (sustainability).
5.5.2 Design and development including testing and validation
As IVD medical device design begins and product requirements are created, essential principles shall
be incorporated as high-level product criteria. The manu facturer may use this document to guide the
identification o f standards to fulfil those essential principles. For example, in the case o f electrical
hazards, the technical solutions to the requirements of the IEC 61010 [13] series are risk control
measures that fulfil the requirements o f the related essential principle. Testing to those requirements
demonstrates that the risk control measure is implemented and the residual risk is acceptable.
Several other standards exist that may be used during this phase, for example, essential principle
seven requires that an IVD medical device has performance evaluation as part of the compliance with
the essential principles. One way to conduct a per formance evaluation is to per form investigations,
whereupon ISO 20916 may be used as requirements to per form this activity.
5.5.3 Regulatory premarket review
During regulatory premarket review, the standards used during the preceding li fe-cycle phases are
identified and linked with the essential principles. This may be done by way o f a checklist that links each
essential principle to the technical solutions applied by the manu facturer with links to the applicable
standards. The manu facturer should create a traceability matrix that links that checklist with the
procedures, test reports and other records that demonstrate con formity with the essential principles.
5.5.4 Production
Several of the process standards are applicable to manufacturing. For example, ISO 13485 and ISO 14971
are applicable to manu facturing processes, the first with requirements to control the manu facturing
process and the latter with requirements for risk management of the manufacturing processes. In
addition, there are many group standards that are applicable to the manu facturing o f IVD medical
devices that may be used to establish product or manu facturing specifications use ful in fulfilling the
essential principles.
EXAMPLE 1 Calibration standard (ISO 17511).
EXAMPLE 2 Labelling [ISO 18113 (all parts)].
EXAMPLE 3 Stability standard (ISO 23640).
5.5.5 Post-production including IVD medical device use and post-market surveillance
During post-production, the main objective o f the manu facturer is to maintain sa fety and per formance
by gathering in formation about the product use and feeding this in formation back into the quality
management system, design development and risk management processes.
NOTE Standards such as ISO/TS 19218-1 can be used as they define a code structure to facilitate this
information gathering and communication.
5.5.6 End of life
End-of-life considerations shall be planned during medical device design. Hazardous waste, shelf life
and obsolescence are all examples of considerations requiring attention.
End-o f-li fe considerations such as environmental impacts are also beginning to be considered by
regulators. Currently, there are few standards that deal directly with this aspect o f the IVD medical

ISO 16142-2:2017(E)
device li fe-cycle. There is an expectation that more standards will be developed in the future to deal
with environmental impacts and in particular end-of-life considerations.
NOTE Although IEC 60601-1-9 [12] is not intended to apply to an IVD medical device, manu facturers can find
use ful in formation on the reduction o f environmental impact (sustainability) in this document.
5.6 Assessing the conformity of an IVD medical device

Con formity assessment is the systematic examination o f records and procedures undertaken by the
manu facturer, under requirements established by the authority having jurisdiction, to determine that
an IVD medical device con forms to the essential principles and is thereby sa fe and per forms as intended
by the manu facturer.
In assessing the con formity o f an IVD medical device with the essential principles, the manu facturer o f
a particular IVD medical device may utilize standards or parts o f several standards and combine them
in a way that is considered to be appropriate for the IVD medical device in question. The use o f parts or
combinations o f standards should be acceptable for con formity assessment purposes.
Where available, specific product standards should be considered. When a product standard does not
exist, consideration should be given to utilizing basic or group standards. Either way, i f the combination
o f standards does not cover all the necessary essential principles o f sa fety and per formance for a
specific IVD medical device, other means o f demonstrating con formance to the essential principles
should be used, such as the creation o f valid scientific evidence for the IVD medical device and essential
principle in question. A manu facturer need not use an available standard and may create valid scientific
evidence in lieu o f using any standard to demonstrate con formance to the essential principles.
6 Essential principles and references to relevant standards and guides
6.1 Use of standards by authorities having jurisdiction

In some countries, authorities having jurisdiction acknowledge the use o f voluntary consensus
standards as one means o f demonstrating compliance with relevant essential principles o f sa fety and
performance of IVD medical devices. Standards suitable to address the essential principles should be
based on:
— a close relationship o f the scope o f the standard to one or more o f the essential principles;
— the clarity and completeness o f the technical requirements contained in the standard as it relates to
a specific essential principle;
— the existence of test methods for determining compliance with each of the technical requirements
in the standard; and
— the definition o f clear acceptance criterion for determining that each technical requirement is met.
These standards should, wherever possible, be International Standards incorporating the thinking of
the global marketplace.
The use of International Standards supports the development of consistent expectations between
authorities having jurisdiction and manu facturers. In the absence o f international consensus standards,
it may be appropriate for authorities having jurisdiction to accept the use o f regional or national
consensus standards or industry standards.
Authorities having jurisdiction should establish and maintain a list o f accepted standards that they
find suitable for demonstrating con formance to these essential principles. Ideally, consensus standards
should not be made mandatory and should be accepted and used without alteration whenever possible.
Annex C contains lists o f standards authorities with jurisdiction found suitable for the IVD medical
device sector and for assessment purposes.

ISO 16142-2:2017(E)
6.2 Manufacturers’ use of essential principles and references to relevant standards

or guides
Before placing an IVD medical device on the market, a manufacturer shall establish that the applicable
essential principles o f sa fety and per formance have been met in a satis factory way. There may be a
number o f ways for a manu facturer to demonstrate compliance to essential principles.
The first six essential principles (see Table B.1) are general and provide the following criteria to ensure
that a medical device (including an IVD medical device):
— is suitable for its intended use;
— achieves intended per formance for its expected li fetime;
— follows good risk management principles and con forms to sa fety principles consistent with the
current acknowledged state o f the art;
— has risks associated with its use that are acceptable;
— is compatible with a high-level o f protection o f health and sa fety for people and the environment;
— provides benefits to the patient that outweighs any risks;
— follows good design, manu facture and packaging principles; and
— is subject to per formance evaluation.
In Annex B , a number o f significant standards are indicated that may be suitable for demonstrating
compliance with specific parts o f each related essential principle. The general essential principles,
applicable to all medical devices including IVD medical devices, are listed in Table B.1. The additional
essential principles
Getfor IVDFREE
more medical devices from
standards are listed in Table
Standard B.2.Group
Sharing When and
selecting standards from
our chats
Annex B , it is important to consider the type o f the medical device and process, as some standards
listed relate to particular families of medical devices or processes (e.g. IEC 61010-2-101 relates to IVD
medical devices).
It is recognized that the requirements in a single standard typically do not meet all the specific parts o f
a given essential principle as related to a given IVD medical device.
The standards referenced in Annex B shall be used as a starting point; however, they should be
checked against a maintained source for the latest effective revision or version and the most recent
publication should be used. Additionally, new or newly revised standards can have an annex that
maps the requirements of the standard to the essential principles of this document and both should be
considered.
There can be available standards not included in this document that may be used to meet a particular
essential principle. Although the intent is to maintain this document on a routine basis, there will
always be new standards that have not yet been considered and are there fore missing.
NOTE Other standards can be available, or under development, that can assist in demonstrating that such an
IVD medical device meets all the relevant essential principles.

ISO 16142-2:2017(E)
Annex A
(informative)
Rationale and guidance
A.1 General guidance

This annex provides a rationale for some requirements of this document and is intended for those
who are familiar with the subject o f this document but who have not participated in its development.
An understanding o f the rationale underlying these requirements is considered to be essential for
their proper application. Furthermore, as clinical practice and technology change, it is believed that a
rationale will facilitate any revision o f this document necessitated by those developments.
A.2 Types of references
A.2.1 General
Informative references give additional information intended to assist the understanding or use of
a standard. They do not contain requirements and should be clear and provide use ful in formation.
Normative references contain requirements and are indispensable for conformance to a standard. The
way in which normatively re ferenced in formation is cited determines the extent (whole or in part) to
which the document applies.
The following subclauses are examples of standards referencing other standards.
A.2.2 Example of normative reference to a group standard
EXAMPLE The requirements specified in ISO 17511 pertaining to calibration and metrological
traceability apply.
NOTE This example is taken from ISO 15197:2013, 4.2.
A.2.3 Example of normative reference to a product standard
EXAMPLE Stability o f reagents and control materials through the expiration dates shall be demonstrated.
The requirements specified in ISO 23640 apply.
A.2.4 Example o f normative re ference to identified requirements, clauses or subclauses
EXAMPLE The manu facturer shall identi fy user inter face characteristics that could be related to sa fety as
part o f a risk analysis per formed according to ISO 14971:2007, 4.2.
NOTE This example is adapted from IEC 62366-1:2015, 5.2.
A.2.5 Example of normative reference from a group standard to a basic standard
EXAMPLE Detachable mains supply cords with mains connectors according to IEC 60320 [16] shall either
meet the requirements of IEC 60799 [17] or shall be rated at least for the current rating of the mains connector
fitted to the cord.
NOTE This example is adapted from IEC 61010-1:2010, 6.10.1.

ISO 16142-2:2017(E)
A.2.6 Example o f speci fying requirement(s) supported by in formative re ference to

group standards
EXAMPLE The organization shall document one or more processes for risk management in product
realization. Records of risk management activities shall be maintained (see 4.2.5).
A.3 Rationale for particular clauses and subclauses

The clauses and subclauses in this annex have been numbered to correspond to the numbering of
the clau s e s and f
s ub clau s e s o th i s f
do c u ment to f
wh ich they re er. T he nu mb eri ng is, there ore, no t
consecutive.
Clause 1 Scope
This fi rs t e d ition o f th i s do c ument wa s develop e d as a n I nternationa l Stand ard and i s i ntende d to
identi fy add itiona l l i n ks b e twe en e xi s ti ng I nternationa l Stand ard s and e s s enti a l pri nciple s o f s a fe ty
and performance of IVD medical devices, as well as encourage and support global convergence of
re gu l ator y s ys tem s . I t i s i ntende d for u s e b y authoritie s havi ng j u ri s d ic tion and m anu fac turers a nd
provide s b enefits i n e s tabl i s h i ng , i n a con s i s tent way, an e conom ic and e ffe c tive appro ach to the control
of IVD medical devices in the interest of public health.

Definition 3.10 IVD medical device
T he defi n ition o f I VD me d ic a l device i nclude s so c a l le d comp a nion I VD me d ic a l device s (e . g. tho s e
i ntende d to de term i ne whe ther a s p e ci fic tre atment i s s u itable for the p atient) . L a rgely, s tanda rd s for
s uch I VD me d ic a l device s have ye t to b e written .

ISO 16142-2:2017(E)
Annex B
(normative)
Table relating essential principles to standards
B.1 General
The list of standards in Table B.1 and Table B.2 shall be considered as a starting point to determine
which standards or which parts of a standard might be applicable to demonstrate conformance to the
essential principles. Additional information regarding demonstration of conformance is found in 5.6.
Not every standard in Table B.1 and Table B.2 is appropriate for any specific IVD medical device and the
manu facturer may disregard any standards that are not applicable. Any re ference standards intended
to be used should be checked against a maintained source for the latest effective revision.
Standards that are re ferenced for a major category o f essential principles are potentially applicable to
most, i f not all, o f the specific essential principles in the category. Where standards are limited to one
or a few specific essential principles, re ferences are made specific to the associated essential principle.
In this annex, a number o f significant standards are indicated which may be suitable for demonstrating
compliance with certain features of the related essential principles. The standards chosen for this annex
are not all inclusive. Those identified are primarily International Standards and regional or national
standards are only used when International Standards do not exist or could not be found. Many o f the
International Standards have regional or national adoptions that may be used. Other standards may be
available, or under development, that can assist in demonstrating that an IVD medical device meets all
the relevant essential principles.
Other types o f documents may be use ful, in particular for standards writers.
— ISO/IEC Guide 51.
— ISO/IEC Guide 63.
For the purposes o f this document, foreseeable should be interpreted to mean reasonably foreseeable
as it is used in ISO 14971 and other relevant standards.
B.2 Essential principles
Table B.1 contains the general principles for all medical devices. Table B.2 contains the additional
principles for IVD medical devices.

ISO 16142-2:2017(E)
Table B.1 — General principles for all medical devices

Essential principle Essential principles of safety and performance of
References a
number medical devices
1 The medical device should be designed and manufactured ISO 13485
f ISO 14971
i n s uch a way th at, when u s e d u nder the cond i tio n s a nd or
f IEC 61010-2-101
the p u r p o s e s i ntende d a nd , where ap p l ic ab le , b y vi r tue o
the technical knowledge, experience, education or training

a nd the me d ic a l a nd p hys ic a l co nd ition s o f i ntende d u s ers ,
it wi l l p er for m a s i ntende d b y the m a nu fac tu rer a nd no t
comprom i s e the cl i n ic a l cond i tio n o r the s a fe ty o f p atients ,
or the s a fe ty a nd he a lth o f u s ers o r, where ap p l ic ab le , o ther
p ers on s , p ro vide d th at a ny ri s ks wh ich m ay b e
associated with its use constitute acceptable risks when

wei ghe d aga i n s t b ene fi ts to the p atient a nd a re co mp atib le
with a h i gh le vel o f p ro te c tion o f he a lth a nd s a fe ty.
This shall include

a) f
re duc i ng , a s AAMI HE75
a r a s re a s on ab l y prac tic ab le a nd
appropriate, the risk of use error due to the design of the ISO 14971
medical device user interface and the environment in which IEC 62366-1
the medical device is intended to be used (design for IEC 62366-2
p atient s a fe ty) , a nd
b) consideration of the technical knowledge, experience, IEC 62366-1

education and training and, where applicable, the medical IEC 62366-2
f
a nd p hys ic a l cond i tio n s o f
i ntende d u s ers (de s i gn o r l ay,
professional, disabled or other users).

2 T he s olutio n s ado p te d b y the m a nu fac tu rer
f ISO 13485 or the de s i gn
and manufacture of the medical device should conform to ISO 14971

f
Get more IEC our
61010-2-101
s a e ty p ri nc ip le s , ta ki n g i nto accou nt the genera l l y
FREE standards from Standard Sharing Group and chats
acknowledged state of the art. When risk reduction is IEC 80002-1
required, the manufacturer should control the risks so that
the re s idu a l r i s k a s s o c i ate d with e ach h a z a rd i s j udge d
accep tab le . T he m a nu fac tu rer s ho u ld app l y the fol lowi n g

pr i nc ip le s i n the pr ior ity order l i s te d:
a) identi fy known or fore s e e ab le ISO 13485

h a z a rd s a nd e s ti m ate the
associated risks arising from the intended use and ISO 14971
fore s e e ab le m i s u s e; ISO/TR 24971
IEC 60812
b) f
el i m i n ate r i s ks , a s ISO 13485
a r a s re a s o n ab l y p rac tic ab le ,
f f
th rough i n herentl y s a e de s i gn a nd m a nu ac tu re; ISO 14971
c) f
re duce , a s ISO 13485
a r a s re a s o n ab l y p rac tic ab le , the rem a i n i ng
ISO 14971
r i s ks b y ta ki ng ade qu ate pro te c tio n me a s u re s , i nclud i n g
f f f
a l a r m s o r i n o r m ation or s a e ty; a nd ISO/TR 24971
IEC 61010-2-101
d) f f
i n o rm u s ers o a ny re s idu a l r i s k. ISO 13485
ISO 14971
ISO/TR 24971
3 The medical device should achieve the performance EN 13612
f
i ntende d b y the m a nu ac tu rer a nd b e de s i gne d , EN 13975
f ISO 13485
m a nu ac tu re d a nd p ackage d i n s uch a way, th at du r i ng
normal conditions of use, it is suitable for its intended use. ISO 14971
IEC 61010-2-101
a S e e a l s o s p e c i fic p ro duc t s ta nd a rd s i n B.3.

ISO 16142-2:2017(E)
Table B.1 (continued)

References a
number medical devices
4 The characteristics and performance referred to in CLSI EP26
essential principles 1, 2 and 3 should not be adversely EN 14136
ISO 13485
a ffected to such a degree that the health or sa fety o f the
patient or the user and, where applicable, of other persons ISO 14971
are compromised during the lifetime of the medical device, ISO 23640
as indicated by the manu facturer, when the medical device IEC 61010-2-101
is subjected to the stresses which can occur during normal
conditions o f use and has been properly maintained in
accordance with the manufacturer’s instructions.
5 The medical device should be designed, manufactured and ISO 13485
packaged in such a way that its characteristics and ISO 14971
per formance during its intended use will not be adversely ISO 23640
a ffected by transport and storage conditions (for example, IEC 61010-2-101
fluctuations o f temperature and humidity) taking account
o f the instructions and in formation provided by the
manufacturer.
6 Any undesirable side-e ffect must constitute an acceptable ISO 13485
risk when weighed against the performance intended. ISO 14971
All known and foreseeable risks, and any undesirable IEC 61010-2-101
effects, should be minimized and be acceptable when IEC 62366-1
weighed against the benefits o f the intended per formance o f IEC 62366-2
the medical device during normal conditions of use.
a See also specific product standards in B.3.
Table B.2 — Additional principles for IVD medical devices

References a
number IVD medical devices
7 Per formance evaluation including analytical per formance and, where appropriate,
clinical performance
7.1 For an IVD medical device, a performance evaluation should CLSI EP05
be conducted. The performance evaluation should review CLSI EP06
analytical per formance data and, where appropriate, clinical CLSI EP07
per formance data in the form o f any CLSI EP09
— scientific, peer-reviewed literature, CLSI EP12
CLSI EP17
— per formance study reports, and CLSI POCT12
— experience gained by routine diagnostic testing
EN 13612
EN 14136
to establish that the IVD medical device achieves its intended ISO 14971
performance during normal conditions of use and that the ISO 17511
known and foreseeable risks, and any undesirable e ffects, are ISO 18153
minimized and acceptable when weighed against the benefits
of the intended performance.
7.2 Clinical performance studies using specimens from human EN 13612
subjects should be carried out in accordance with the spirit
o f the Declaration o f Helsinki. This includes every step in
the clinical per formance study from first consideration o f
the need and justification o f the study to publication o f the
results. In addition, some countries may have specific
regulatory requirements for in formed consent.
NOTE Content and format of a performance evaluation
report is specific to the authority having jurisdiction.
8 Chemical, physical and biological properties

ISO 16142-2:2017(E)

References a
8.1 The IVD medical device should be designed and EN 13532
f
m a nu ac tu re d i n s uch a way a s to en s u re the ch a rac ter i s tic s ISO 13485
and performance referred to in essential principle 6. ISO 14971
P a r tic u l a r attentio n s hou ld b e p a id to the p o s s ib i l ity o f
i mp a i r ment o f a n a l ytic a l p er fo r m a nce due to i nco mp atibi l ity
b e twe en the m ater i a l s u s e d a nd the s p e c i men s or a n a l y te
(measurand) to be detected (such as biological tissues, cells,

b o dy flu id s a nd m ic ro o rga n i s m s) , ta ki ng acco u nt o f its
intended use.
8.2 The IVD medical device should be designed, manufactured ISO 13485
EN 13532
a nd p ackage d i n s uch a way a s to m i n i m i z e the r i s k p o s e d
ISO 14971
b y conta m i n a nts a nd re s idue s to the p ers on s i nvo l ve d i n the
transport, storage and use of the IVD medical device and to

patients, taking account of the intended use of the IVD
medical device.
8.3 The IVD medical device should be designed and ISO 13485
f f
m a nu ac tu re d i n s uch a way a s to re duce , a s EN 13532ar as
ISO 14971
re a s o n ab l y p rac tic ab le a nd app rop r i ate , the ri s ks p o s e d b y
f
s ub s ta nce s th at m ay le ach or le a k ro m the I VD me d ic a l
device.
Special attention should be given to substances, which are
carcinogenic, mutagenic or toxic to reproduction.
f f
m a nu ac tu re d i n s uch a way a s to re duce , a s EN 13532a r a s re a s o n ab l y
ISO 14971
prac tic ab le a nd ap prop ri ate , the r i s ks p o s e d b y the
unintentional
Get more ingress or egress
FREE standards of substances
from Standard into orGroup
Sharing from andIECour61010-2-101
chats
the IVD medical device taking into account the
IVD medical device and the nature of the environment in
which it is intended to be used.
9 Infection and microbial contamination
9.1 The IVD medical device and manufacturing processes should EN 13641
f ISO 14971
b e de s i gne d i n s uch a way a s to el i m i n ate or to re duce , a s ar
f IEC 62366-1
a s re a s o n ab l y p rac tic ab le a nd app ro pr i ate , the r i s k o
f f IEC 62366-2
i n e c tion to u s er, p ro e s s io n a l o r l ay, o r, where app l ic ab le ,
other person. The design should:

a) f IEC 62366-1
a l low e a s y a nd s a e h a nd l i n g , a nd , where ne ce s s a r y,
IEC 62366-2
b) f
re duce , a s EN 13641
a r a s re a s o n ab l y p rac tic ab le a nd app rop r i ate ,
f
a ny m ic rob i a l le a kage ISO 14971
rom the I VD me d ic a l de vice o r
microbial exposure during use, and IEC 62366-1

IEC 62366-2
c) prevent microbial contamination of the IVD medical ISO 11607 (all parts)
ISO 14971
de vice or s p e c i men , where ap p l ic ab le , b y the u s er,
fpro e s s ion a l or l ay or o ther p ers o n . IEC 62366-1

IEC 62366-2
9.2 The IVD medical device labelled either as sterile or as having ISO 11607 (all parts)
a special microbiological state should be designed, EN 13641
manufactured and packaged to ensure it remains so when ISO 14644 (all parts)
placed on the market and remains so under the transport and ISO 14698 (all parts)
f
s torage cond i tio n s s p e c i fie d b y the m a nu ac tu rer u nti l the
protective packaging is damaged or opened.


ISO 16142-2:2017(E)

References a
9.3 The IVD medical device labelled either as sterile or as having ISO 11135 (all parts)
a special microbiological state should have been processed, ISO 11137 (all parts)
f f
m a nu ac tu re d a nd , i app l ic ab le , s ter i l i z e d b y ap pro pr i ate , ISO 11138 (all parts)
validated methods. ISO 11140 (all parts)
ISO 11607 (all parts)
ISO/TS 13004
ISO 14161
ISO 14937
ISO 15882
ISO 18472
ISO 20857
ISO 25424
9.4 The IVD medical device intended to be sterilized should be ISO 14644 (all parts)
m a nu fac tu re d i n app rop r i atel y control le d (e . g. ISO 14698 (all parts)
environmental) conditions. ISO 11607 (all parts)
9.5 P ackagi n g s ys tem s fo r a non- s ter i le I VD me d ic a l de vice
s hou ld m a i nta i n the i nte gr i ty a nd cle a n l i ne s s o f the I VD
medical device.
10 IVD medical devices incorporating materials of biological origin
These essential principles are not intended to provide guidance on combination
p ro duc ts a s a whole s i nce de fi n ition s h ave ye t to b e h a r mo n i z e d a nd prac tice va r ie s
b e twe en d i fferent j u r i s d ic tion s .
10.1 Where the IVD medical device include tissues, cells and ASTM F2027
substances originating from animals, the processing, EN 13641
preservation, testing and handling of tissues, cells and ISO 22442 (all parts)
substances of animal origin should be carried out to provide
o p ti m a l s a fe ty for u s er, pro fe s s ion a l or l ay, or o ther p ers on .
10.2 S a fe ty with re ga rd to vi r u s e s a nd o ther tra n s m i s s ib le agents ASTM F2027

s hou ld b e add re s s e d b y i mp lementatio n o f va l idate d me tho d s EN 13641
of elimination or inactivation in the course of the ISO 22442 (all parts)
m a nu fac tu r i ng p ro ce s s . T h i s m ay no t app l y to cer ta i n I VD
me d ic a l device s i f the ac ti vity o f the vi r u s a nd o ther
transmissible agent are integral to the intended use of the

IVD medical device or when such elimination or inactivation
process would compromise the performance of the IVD
medical device.
N atio n a l re gu l ation s m ay re qu i re th at the m a nu fac tu rer or
the author ity h avi n g j u r i s d ic tio n re ta i n i n fo r m ation on the
geographical origin of the animals.


ISO 16142-2:2017(E)

References a
10.3 Where an IVD medical device includes human tissues, cells ASTM F2027
and substances, the selection of sources, donors or EN 13641
substances of human origin, processing, preservation, ISO 22442 (all parts)
testing and handling of tissues, cells and substances of such
origin should be carried out to provide optimal sa fety for
user, pro fessional or lay, or other person.
In particular, sa fety with regard to viruses and other
transmissible agents should be addressed by
implementation of validated methods of elimination or
inactivation in the course of the manufacturing process. This
may not apply to certain IVD medical devices i f the activity
of the virus and other transmissible agent are integral to the
intended use of the IVD medical device or when such
elimination or inactivation process would compromise the
performance of the IVD medical device.
10.4 Where an IVD medical device includes cells and substances ASTM F2027
of microbial origin, the processing, preservation, testing EN 13641
and handling of cells and substances should be carried out ISO 22442 (all parts)
to provide optimal sa fety for user, pro fessional or lay, or
other person.
In particular, sa fety with regard to viruses and other
transmissible agents should be addressed by
implementation of validated methods of elimination or
inactivation in the course of the manufacturing process. This
may not apply to certain IVD medical devices i f the activity
of the virus
Get more FREEand other transmissible
standards agent Sharing
from Standard are integral to theand our chats
Group
intended use of the IVD medical device or when such
elimination or inactivation process would compromise the
performance of the IVD medical device.
11 Environmental properties
11.1 If the IVD medical device is intended for use in ASTM F2027
combination with other medical devices or equipment, the ISO 18113 (all parts)
whole combination, including the connection system should ISO 22442 (all parts)
not impair the specified per formance o f the medical devices.
Any restrictions on use applying to such combinations should
be indicated on the label or in the instructions for use.

ISO 16142-2:2017(E)

References a
11.2 The IVD medical device should be designed and ASTM F2761
m a nu fac tu re d i n s uch a way a s to remove or re duce , a s fa r ISO 14971
a s re a s on ab l y prac tic ab le a nd ap prop ri ate , the fo l lowi ng: ISO/IEEE 11073 (all
parts)
IEC 61010-2-101
IEC/ISO 80001-1
IEC/TR 80001-2-1
a) the ri s k o f i nj u r y to u s er, p ro fe s s io n a l o r l ay, or o ther ISO 14971
p ers o n i n co n ne c tion wi th thei r p hys ic a l a nd ergo nom ic
fe atu re s;
b) the risk of use error due to the ergonomic features, ISO 14971
human factors and the environment in which the IVD medical IEC 62366-1
device i s i ntende d to b e u s e d; IEC 62366-2
c) f
the r i s ks con ne c te d with re a s on ab l y AAMI HE75
ore s e e ab le e x tern a l
i n fluence s o r envi ro n menta l cond i tio n s , s uch a sISO 14971

IEC 61010-2-101
m agne tic field s , e x ter n a l ele c tric a l a nd ele c trom agne tic
eff IEC 61326-2-6

e c ts , ele c tro s tatic d i s ch a rge , p re s s u re , hu m id ity,
f
temp eratu re or va r i ation s there o ; IEC 62366-1
IEC 62366-2
d) the risks associated with the use of the IVD medical ISO 14971
device when it comes into contact with materials, liquids and IEC 61010-2–101
ga s e s to wh ich it i s e xp o s e d du ri n g no rm a l co nd ition s o f u s e;
e) the risk associated with the possible negative ASTM F2761

interaction between software and the environment within ISO/IEEE 11073 (all
wh ich it op erate s a nd i nterac ts; parts)
ISO 14971
IEC 62304
IEC/ISO 80001-1
IEC/ISO 80002-1
IEC 82304-1
f) the risks of accidental penetration of substances into the ISO 14971
I VD me d ic a l device; IEC 61010-2-101
g) f
the r i s k o f - ISO 14971
i nco r re c t identi fic atio n o s p e c i men s/s a m
p le s ; a nd
h) the ri s ks o f re a s on ab l y fo re s e e ab le i nter ference with AAMI HE75

o ther me d ic a l de vice s s uch a s c a rr y over b e twe en I VD ISO 14971
medical devices. IEC 61326-2-6
IEC 61010-2-101
IEC 62366-1
IEC 62366-2
f f
m a nu ac tu re d i n s uch a way a s to m i n i m i z e the ri s ks o fi re IEC 61010-2-101
or explosion during normal use and in single fault condition.
Particular attention should be paid to an IVD medical device
whose intended use includes exposure to or use in
a s s o c i ation wi th fl a m m ab le s ub s ta nce s o r s ub s ta nce s th at
could promote combustion.

11.4 The IVD medical device should be designed and AAMI HE75
f ISO 14971
m a nu ac tu re d i n s uch a way th at adj u s tment, c a l ib ration a nd
IEC 61010-2-101
m a i nten a nce , where s uch i s ne ce s s a r y to ach ieve the
f f
p er or m a nce i ntende d , c a n b e done s a el y. IEC 62366-1
IEC 62366-2

ISO 16142-2:2017(E)

References a
m a nu fac tu re d i n s uch a way a s to fac i l itate the s a fe d i s p o s a l IEC 61010-2-101
o f a ny wa s te s ub s ta nce s .
12 Performance characteristics
12.1 The IVD medical device should be designed and CLSI EP05
f f CLSI EP06
m a nu ac tu re d i n s uch a way th at the p er o r m a nce
characteristics support the intended use based on CLSI EP07

CLSI EP09
ap pro pr i ate s c ienti fic a nd te ch n ic a l me tho d s . I n p a r tic u l a r,
CLSI EP12
where app ro pr i ate , the de s i gn s hou ld add re s s s en s iti vity,
f
s p e c i fic ity, acc u rac y, wh ich re s u lts CLSI EP17
rom tr uene s s ( b i a s) a nd
f CLSI POCT12
pre c i s io n (rep e atab i l i ty a nd repro duc ib i l i ty) , control o
known relevant interferences and limits of detection. EN 13612

These performance characteristics need to be maintained EN ISO
13975
2859
f
the manufacturer.
f
du r i ng the l i e ti me o
ISO 3951
the I VD me d ic a l de vice a s i nd ic ate d b y
ISO 15193
ISO 15194
ISO 15195
ISO 15197
ISO/IEC 17025
ISO 17511
ISO 17593
ISO 18153
ISO 23640
12.2 WhereFREE
Get more the performance
standardsoffrom
an IVD medical Sharing
Standard device depends
GrouponandCLSI
ourEP14
chats
f
the u s e o ISO 15193
c a l ib rato rs or control m ateri a l s , the trace ab i l ity
of values assigned to such calibrators or control materials ISO 15194

should be ensured through available reference measurement ISO 15195
procedures or available reference materials of a higher order. ISO/IEC 17025
ISO 17511
ISO 18153
12.3 IEC 62366-1
Wherever p o s s ib le , va lue s e xp re s s e d nu meric a l l y s ho u ld b e
IEC 62366-2
i n com mon l y accep te d , s ta nda rd i z e d u n i ts a nd u nders to o d
f
b y the u s ers o the I VD me d ic a l de vice . IEC 80000 (all parts)
13 Protection against radiation
13.1 The IVD medical device should be designed, manufactured IEC 60825 (all parts)
f
a nd p ackage d i n s uch a way th at e xp o s u re o IEC 61326-2-6u s er,
f IEC 62471
pro e s s ion a l or l ay, or o ther p ers on to the em itte d rad i atio n
(i ntende d, u n i ntende d, s tray o r s c attere d) i s re duce d a s fa r

a s re a s o n ab l y p rac tic ab le a nd app ro pr i ate .
13.2 When the I VD me d ic a l de vice i s i ntende d to em i t p o tenti a l l y
hazardous, visible or invisible radiation, it should as far as

re a s o n ab l y p rac tic ab le a nd app rop r i ate b e:
a) de s i gne d a nd m a nu fac tu re d i n s uch a way a s to en s u re IEC 60825 (all parts)

th at the ch a rac ter i s tic s a nd the qu a nti ty o f rad i ation em itte d IEC 62471
c a n b e co ntro l le d o r adj u s te d; a nd
b) f IEC/TR 80001-2-5
fitte d with vi s u a l d i s p l ays or aud ib le wa rn i n gs o s uch
emissions.
14 IVD medical devices that incorporate software and standalone IVD medical device
software

ISO 16142-2:2017(E)

References a
14.1 For the IVD medical device, which incorporates software ISO/IEC 15026 (all parts)
or for standalone software that is an IVD medical device in IEC 62304
itself, the software shall be validated according to the state IEC 82304-1
of the art taking into account the principles of development
l i fe - c ycle , r i s k m a n agement, veri fic atio n a nd va l idation .
15 I VD me d ic a l device s con ne c te d to , or e qu ipp e d wi th , a n energ y s o u rce
15.1 T he I VD me d ic a l device , where the s a fe ty o f the p atient ISO 14971

dep end s on a n i nter n a l p ower s upp l y i n the I VD me d ic a l
device, should be equipped with a means of determining the

s tate o f the p ower s upp l y.
15.2 The IVD medical device should be designed and IEC 61326-2-6
f f
m a nu ac tu re d i n s uch a way a s to re duce , a s a r a s re a s on ab l y
practicable and appropriate, the risks of creating

electromagnetic interference which could impair the
operation of this or other medical devices or equipment in
the usual environment.
m a nu fac tu re d i n s uch a way a s to p ro vide a n ade qu ate le vel
o f i ntri n s ic i m mu n ity to ele c trom agne tic d i s tu rb a nce to
enable them to operate as intended.

f f
m a nu ac tu re d i n s uch a way a s to avoid , a s a r a s re a s on ab l y
practicable, the risk of accidental electric shocks to the user,

f f
p ro e s s io n a l o r l ay, o r o ther p ers on b o th du ri n g no rm a l u s e o
the IVD medical device and in the event of a single fault

condition in the IVD medical device, provided the IVD
me d ic a l device i s i n s ta l le d a nd m a i nta i ne d a s i nd ic ate d b y
the manufacturer.
16 Protection against mechanical and thermal risks
f
m a nu ac tu re d i n s uch a way a s to p ro te c t the u s er, IEC 61010-2-101
f
p ro e s s io n a l o r l ay, o r o ther p ers on aga i n s t me ch a n ic a l r i s ks
connected with, for example, resistance to movement,

i n s tabi l ity a nd movi n g p a r ts .
16.2 Where there are risks due to the presence of moving parts, ISO 14971
risks due to break-up or detachment, or leakage of IEC 61010-2-101
substances, then appropriate protection means shall be
incorporated.
f
m a nu ac tu re d i n s uch a way a s to re duce to the lowe s t IEC 60068 (all parts)
practicable level the risks arising from vibration generated
f
b y the I VD me d ic a l de vice , ta ki ng accou nt o te ch n ic a l
progress and of the means available for limiting vibrations,

p a r tic u l a rl y at s o u rce , u n le s s the vibration s a re p a r t o f the
s p e c i fie d p er fo rm a nce .
f
m a nu ac tu re d i n s uch a way a s to re duce to the lowe s t
practicable level the risks arising from the noise emitted,

taking account of technical progress and of the means
ava i l ab le to re duce no i s e p a r tic u l a rl y at s ou rce .
16.5 Term i n a l s a nd con ne c to rs to the ele c tr ic i ty, ga s o r hyd rau l ic ISO 14971
a nd pneu m atic energ y s upp l ie s wh ich the u s er, pro fe s s ion a l IEC 61010-2-101
o r l ay, o r o ther p ers on s ho u ld h a nd le s ho u ld b e de s i gne d a nd
con s tr uc te d i n s uch a way a s to m i n i m i z e a l l p o s s ib le r i s ks .

ISO 16142-2:2017(E)

References a
f
m a nu ac tu re d i n s uch a way a s to re duce to the lowe s t IEC 61010-2-101
practicable level the risk of error when certain parts within IEC 62366-1
the IVD medical device are intended to be connected or IEC 62366-2
reconnected before or during use.
16.7 Accessible parts of the IVD medical device (excluding the IEC 61010-2–101
p a r ts or a re a s i ntende d to s up p l y he at or re ach gi ven
temperatures) and their surroundings should not attain

p o tenti a l l y d a ngerou s temp eratu re s u nder no rm a l u s e .
17 P ro te c tion aga i n s t the r i s ks p o s e d b y I VD me d ic a l de vice s fo r s el f- te s ti n g
17.1 The IVD medical device for self-testing should be designed AAMI HE75
a nd m a nu fac tu re d i n s uch a way th at i t p er fo rm s EN 13532
ap pro pr i atel y for its i ntende d u s e ta ki ng i nto acco u nt the EN 13612
s ki l l s a nd the me a n s ava i l ab le to l ay p ers on s a nd the ISO 15197
i n fluence re s u lti n g from va r i ation th at c a n re a s on ab l y b e ISO 17593
a ntic ip ate d i n the l ay p ers o n’s te ch n ique a nd envi ron ment. ISO 18113-1
T he i n fo r m ation a nd i n s tr uc tion s p rovide d b y the ISO 18113-4
m a nu fac tu rer s hou ld b e e a s y for the l ay p ers on to ISO 18113-5
u nders ta nd a nd app l y. IEC 62366-1
IEC 62366-2
17.2 The IVD medical device for self-testing should be designed IEC 62366-1
a nd m a nu fac tu re d i n s uch a way a s to re duce , a s fa r as IEC 62366-2
re a s o n ab l y p rac tic ab le , the r i s k o f u s e er ro r b y the l ay p ers o n
in the handling of the IVD medical device and, if applicable,

the specimen, and also in the interpretation of results.
17.3 The IVD medical device for self-testing should, where ISO 18113-1
ISO 18113-4
re a s o n ab l y p o s s ib le , i nclude a pro ce du re b y wh ich the l ay
f f
p ers on c a n veri y th at, at the ti me o ISO 18113-5
u s e , the pro duc t wi l l
f f
p er o r m a s i ntende d b y the m a nu ac tu rer. IEC 62366-1
IEC 62366-2
18 G enera l re qu i rements re ga rd i n g the i n for m atio n s upp l ie d b y the m a nu fac tu rer
18.1 ISO 14971

E ach I VD me d ic a l device s h a l l b e acco mp a n ie d b y the
ISO 15223-1
i n for m ation ne e de d to identi fy the I VD me d ic a l de vice a nd
f f f ISO 18113 (all parts)

its m a nu ac tu rer a nd co m mu n ic ate s a e ty a nd p er o rm a nce
f f ISO/TR 24971
rel ate d i n o r m ation to the u s er, p ro e s s ion a l or l ay, o r o ther
f IEC 60878
p ers on , a s ap pro pr i ate . T h i s i n or m atio n s hou ld b e e a s i l y
f IEC 61010-2-101
u nders to o d . S uch i n or m atio n m ay ap p e a r o n the I VD
medical device itself, on the packaging or in the instructions IEC 62366-1

f f IEC 62366-2
or u s e . T he acco mp a nyi ng i n or m atio n s h a l l me e t the
f
re qu i rements o the author i ty h avi ng j u r i s d ic tion a nd
contain the following particulars.

a) f
T he me d iu m , f ISO 15223-1
or m at, content, le gib i l i ty a nd lo c ation o
the label and instructions for use shall be appropriate to ISO 18113 (all parts)
the particular IVD medical device, its intended use and the IEC 60878
technical knowledge, experience, education or training of IEC 62366-1
the intended user(s). In particular, instructions for use shall IEC 62366-2
b e wr i tten i n ter m s re ad i l y u nders to o d b y the i ntende d u s er
and, where appropriate, supplemented with drawings and

d i agra m s . S ome I VD me d ic a l de vice s m ay i nclude s ep a rate
i n for m ation fo r the p ro fe s s ion a l u s er a nd the l ay p ers o n .

ISO 16142-2:2017(E)

References a
b) The information required on the label, shall be provided ISO 15223-1
on the IVD medical device itself. If this is not practicable or ISO 18113 (all parts)
appropriate, some or all o f the in formation may appear on IEC 60878
the packaging for each unit or on the packaging of multiple
IVD medical devices. Where multiple IVD medical devices
are supplied to a single user or location, a single copy o f the
instructions for use may be provided i f so agreed by the
purchaser who in any case may request further copies to be
provided.
ISO 15223-1
c) In duly justified and exceptional cases, instructions for
use may not be needed or may be abbreviated i f the IVD ISO 18113 (all parts)
medical device can be used sa fely and as intended by the IEC 60878
manu facturer without any such instructions for use. IEC 62366-1
IEC 62366-2
d) Labels shall be provided in a human-readable format but ISO 18113 (all parts)
may be supplemented by machine-readable forms, such as
radio- frequency identification (RFID) or bar codes.
e) When the IVD medical device is intended for professional ISO 18113 (all parts)
use only, instructions for use may be provided to the user in
non-paper format (e.g. electronic), except when the IVD
medical device is intended for near-patient testing.
f) Residual risks, which are required to be communicated ISO 14971
to the user or other person, shall be included as limitations, ISO 18113 (all parts)
contraindications, precautions or warnings in the IEC 62366-1
in formation supplied by the manu facturer. IEC 62366-2
g) Where appropriate, this information should take the ISO 15223-1
form o f internationally recognized symbols. Any symbol ISO 18113 (all parts)
or identification colour used shall con form to the accepted IEC 60878
standards. The symbols and colours shall be described in the IEC 61010-2-101
documentation supplied with the IVD medical device.
h) In the case of an IVD medical device containing a ISO 18113 (all parts)
substance or a mixture which can be considered as being IEC 61010-2-101
dangerous, taking account o f the nature and quantity o f its
constituents and the form under which they are present,
relevant hazard pictograms and labelling requirements
shall apply. Where there is insu fficient space to put all the
information on the IVD medical device itself, the relevant
hazard pictograms shall be put on the label and the other
in formation required by that regulation shall be given in the
instructions for use.
i) The provisions on the sa fety data sheet for any substance
or mixtures shall apply unless all relevant in formation as
appropriate is already made available by the instructions for
use.
j) For a reagent derived from biological material, the source ISO 18113 (all parts)
and, where applicable, a measure o f its activity.
18.2 The label shall meet the requirements o f the authority having ISO 18113 (all parts)
jurisdiction and contain the following particulars:
a) the name or trade name o f the IVD medical device; ISO 15223-1
IEC 60878
IEC 61010-2-101

ISO 16142-2:2017(E)

References a
ISO 15223-1
b) the details strictly necessary for the user to identi fy the
IVD medical device and, where it is not obvious for the user, ISO 18113 (all parts)
the intended use o f the IVD medical device; IEC 60878
c) the name or trade name and address of the manufacturer ISO 15223-1
and where the manufacturer does not have an address within ISO 18113 (all parts)
the locale, an authorized representative within the locale to IEC 60878
which the user can re fer; IEC 61010-2-101
d) an indication that the IVD medical device is for in vitroISO 15223-1
diagnostic use; ISO 18113 (all parts)
IEC 60878
IEC 61010-2-101
e) the batch code/lot number or the serial number of the ISO 15223-1
IVD medical device and separate components preceded by ISO 18113 (all parts)
the word LOT or SERIAL NUMBER or an equivalent symbol, IEC 60878
as appropriate, or the equivalent; IEC 61010-2-101
f ) where applicable, the unique device identification (UDI);
g) an unambiguous indication of the date until when the ISO 15223-1
IVD medical device, or any o f its components, may be used ISO 18113 (all parts)
sa fely, without degradation o f per formance, expressed at IEC 60878
least as the year, the month and, where relevant, the day, in
that order, or where there is no indication of the date until
when it may be used sa fely, the year o f manu facture. This
year o f manu facture may be included as part o f the batch or
serial number, provided the date is clearly identifiable;
h) where
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contents, expressed in terms of weight, concentration,
volume, numerical count, or any combination o f these, or
other terms which accurately reflect the contents o f the
package;
i) an indication o f any special storage or handling condition ISO 18113 (all parts)
that applies;
j) where appropriate, an indication o f the sterile state o f the ISO 15223-1
IVD medical device and the sterilization method or a ISO 18113 (all parts)
statement indicating any special microbiological state or IEC 60878
state o f cleanliness;
k) warnings or precautions to be taken that need to be ISO 15223-1
brought to the immediate attention of the user, ISO 18113 (all parts)
pro fessional or lay, or other person. This in formation may be IEC 60878
kept to a minimum in which case more detailed IEC 61010-2-101
in formation shall appear in the instructions for use;
l) where applicable, any particular operating instructions; ISO 18113 (all parts)
IEC 61010-2-101
m) if the IVD medical device is intended for single use or ISO 15223-1
single-patient use, an indication of that fact. A ISO 18113 (all parts)
manufacturer’s indication of single use or single-patient use IEC 60878
shall be consistent for a model or type re ference;
n) if the IVD medical device is intended for self-testing or ISO 18113 (all parts)
near-patient testing, an indication o f that fact; IEC 61010-2-101
o) i f the IVD medical device is for “per formance evaluation ISO 18113 (all parts)
only”, an indication o f that fact; and
NOTE The actual text o f the indication is authority having
jurisdiction-specific.

ISO 16142-2:2017(E)

References a
p) where an IVD medical device kit includes individual ISO 18113 (all parts)
reagents and articles that can be made available as a
separate IVD medical device, each such IVD medical device
s h a l l co mp l y wi th the l ab el l i n g re qu i rements co nta i ne d 1 8 . 2 .
18.3 The instructions for use shall meet the requirements of the ISO 18113 (all parts)
f
author ity h avi n g j u r i s d ic tion a nd conta i n the ol lowi ng
particulars:
a) the n a me or trade n a me o f the I VD me d ic a l de vice; ISO 15223-1
IEC 60878
b) the IVD medical device’s intended use: ISO 18113 (all parts)
i) what is detected or measured and whether it is ISO 18113 (all parts)
qualitative, quantitative or a combination of both,
ii) the operating principle, ISO 18113 (all parts)
iii) its function (e.g. screening, monitoring, diagnosis or ISO 18113 (all parts)
support of diagnosis),
i v) f f ISO 18113 (all parts)
the s p e c i fic d i s order, co nd ition or r i s k ac to r o
i ntere s t th at it i s i ntende d to de te c t, de fi ne o r d i fferenti ate ,
v) the typ e o f s p e c i men(s) re qu i re d, ISO 18113 (all parts)

vi) the intended user and intended patient population, and ISO 18113 (all parts)
vi i) the u s e envi ron ment; ISO 18113 (all parts)
c) an indication that the IVD medical device is for ISO 15223-1 in vitro
d i agno s tic u s e; ISO 18113 (all parts)

IEC 60878
d) f
a de s c r ip tion o the te s t p r i nc ip le;ISO 18113 (all parts)
e) instructions from reception of the specimen to obtaining ISO 18113 (all parts)
a nd a n a l ys i ng re s u lts to en s u re th at the I VD me d ic a l device
p er for m s a s i ntende d (e . g. c a l ib ratio n , qu a l ity co ntro l ,
cle a n i ng a nd d i s i n fe c tio n) ;
f) a description of the reagents, calibrators and controls ISO 18113 (all parts)
a nd a ny l i m itation up on thei r u s e (e . g. s u itab le for a
de d ic ate d i n s tr u ment o n l y) i f app l ic ab le;
g) a list of materials provided and a list of special materials ISO 18113 (all parts)
o r e qu ip ment re qu i re d b ut no t p rovide d;
h) for IVD medical devices intended for use together with

other medical devices, including IVD medical devices, or
equipment:
i) i n for m ation to identi fy s uch I VD me d ic a l de vice s or
equipment, in order to obtain a safe combination, or

i i) i n for m ation on a ny known re s tr ic tion s to
combinations of medical devices, including IVD medical

device s , a nd e qu ip ment;
i) a n i nd ic ation o f a ny s torage (e . g. temp eratu re , l i ght, ISO 18113 (all parts)

hu m id i ty, du s t) o r h a nd l i ng co nd ition s wh ich app l y; IEC 61010-2-101
j) a n i nd ic atio n o f a ny o p erati ng (e . g. temp eratu re , l i ght, ISO 18113 (all parts)
hu m id i ty, du s t) o r h a nd l i ng co nd ition s wh ich app l y; IEC 61010-2-101
k) where releva nt, a ny ch a nge i n the s hel f l i fe fol lowi ng ISO 18113 (all parts)
the fi rs t op en i ng o f the pr i m a r y conta i ner, to ge ther with the
s torage cond ition s a nd s tab i l i ty o f worki ng s o lution s;

ISO 16142-2:2017(E)

References a
l) if the IVD medical device is supplied as sterile, an ISO 15223-1
indication of its sterile state, the sterilization method and ISO 18113 (all parts)
instructions in the event of the sterile packaging being IEC 60878
d a m age d b e fore u s e;
m) i n for m atio n th at a l lows the u s er to b e i n fo r me d o f a ny ISO 15223-1

warnings, precautions, measures to be taken and limitations ISO 18113 (all parts)
of use regarding the IVD medical device. This information IEC 60878
shall cover, where appropriate: IEC 61010-2-101
i) warnings, precautions or measures to be taken in the ISO 18113 (all parts)
event of malfunction of the IVD medical device or its IEC 61010-2-101
de grad atio n a s s u gge s te d b y ch a nge s i n i ts app e a ra nce th at
m ay a ffe c t p er fo rm a nce ,
ii) warnings, precautions or measures to be taken in ISO 18113 (all parts)

re ga rd to the e xp o s u re to re a s on ab l y fore s e e ab le e x ter n a l IEC 61010-2-101
i n fluence s o r envi ro n menta l cond i tio n s , s uch a s m agne tic IEC 61326-2-6
field s , e x ter n a l ele c tr ic a l a nd ele c tro m agne tic e ffe c ts ,
electrostatic discharge, radiation associated with diagnostic

or therap eutic p ro ce du re s , pre s s u re , hu m id i ty o r
temperature,
iii) warnings, precautions or measures to be taken in ISO 18113 (all parts)
f
re ga rd to the ri s ks of IEC 61010-2-101
i nter erence p o s e d b y the
f
re a s o n ab l y f
o re s e e ab le p re s ence o IEC 61326-2-6
the I VD me d ic a l device
during diagnostic procedures, evaluations or therapeutic

f
tre atments (e . g. ele c trom agne tic i nter erence em i tte d b y the
IVD medical device affecting other equipment),

iv) precautions related to materials incorporated into the
IVD medical device that are carcinogenic, mutagenic or toxic,
or that have endocrine disrupting properties or that could
result in sensitization or allergic reaction of the patient or user,
v) if the IVD medical device is intended for single use or ISO 15223-1
single-patient use, an indication of that fact. A ISO 18113 (all parts)
manufacturer’s indication of single use or single-patient use IEC 60878
s h a l l b e con s i s tent for a mo del o r typ e re ference , a nd
vi) if the IVD medical device is reusable, information on

the appropriate processes to allow reuse, including cleaning,
disinfection, decontamination, packaging and, where
appropriate, the validated method of re-sterilization.
f f
I n or m atio n s h a l l b e pro vide d to identi y when the I VD
medical device should no longer be reused, e.g. signs of

material degradation or the maximum number of allowable
reu s e s;
n) a ny wa r n i n gs or p re c autio n s rel ate d to p o tenti a l l y ISO 18113 (all parts)

i n fe c tiou s m ater i a l th at i s i nclude d i n the I VD me d ic a l de vice;
o) where relevant, requirements for special facilities (e.g. IEC 61010-2-101

clean room environment) or special training (e.g. radiation
s a fe ty) or p a r tic u l a r qu a l i fic ation s o f the I VD me d ic a l de vice
i ntende d u s er;
p) conditions for collection, handling and preparation of the ISO 18113 (all parts)
s p e c i men i nclud i ng add iti ve a nd p re s er vati ve s ne ce s s a r y to
m a i nta i n the i nte gri ty o f the s p e c i men a nd re com mende d
storage, handling or shipping instructions for the protection

a nd m a i nten a nce o f s tab i l i ty o f the s p e c i men , i f app ro pr i ate;

ISO 16142-2:2017(E)

References a
q) de ta i l s o f a ny p rep a rator y tre atment o r h a nd l i n g o f the ISO 18113 (all parts)
I VD me d ic a l device b e fore it i s re ady for u s e (e . g. IEC 61010-2-101
s teri l i z ation , fi n a l a s s emb l y, c a l ibration , e tc .) ;
r) the i n fo r m ation ne e de d to veri fy whe ther the I VD ISO 18113 (all parts)
me d ic a l device i s p rop erl y i n s ta l le d a nd i s re ady to p er for m IEC 61010-2-101
s a fel y a nd a s i ntende d b y the m a nu fac tu rer, to ge ther with ,
where relevant:
i) de ta i l s o f the n atu re , a nd fre quenc y, o f pre ventati ve a nd IEC 61010-2-101
regular maintenance, including cleaning and disinfection,
i i) identi fic ation o f a ny co n s u m ab le co mp onents a nd how ISO 18113 (all parts)
to replace them, IEC 61010-2-101
i i i) i n fo r m ation on a ny ne ce s s a r y c a l ibratio n to en s u re ISO 17511
th at the I VD me d ic a l de vice o p erate s p rop erl y a nd s a fel y ISO 18113 (all parts)
during its intended lifetime, and ISO 18153
i v) me tho d s o f m iti gati n g the ri s ks encou ntere d b y IEC 61010-2-101
persons involved in installing, calibrating or servicing the
I VD me d ic a l device;
s) where releva nt, re com mend ation s for qu a l ity co ntro l ISO 18113 (all parts)
p ro ce du re s;
t) the me trolo gic a l trace ab i l ity o f va lue s a s s i gne d to ISO 17511

calibrators and trueness-control materials, including ISO 18113 (all parts)
identi fic ation o f app l ic ab le re ference m ater i a l s or re ference
me a s u rement p ro ce du re s o f h i gher order;
u) a s s ay pro ce du re i nclud i ng c a lc u l atio n s a nd ISO 18113 (all parts)

i nter p re tation o f re s u lts a nd where releva nt, i f a ny,
con fi r m ato r y te s ti ng i s ne ce s s a r y;
v) p er for m a nce ch a rac teri s tic s , to the e x tent ne ce s s a r y fo r ISO 17511

the I VD me d ic a l de vice to b e u s e d s a fel y a nd e ffe c ti vel y [e . g. ISO 18113 (all parts)
cl i n ic a l s en s i ti vi ty, cl i n ic a l s p e c i fic ity, p o s iti ve pre d ic ti ve
va lue , ne gati ve p re d ic ti ve va lue , acc u rac y wh ich re s u lts from

tr uene s s ( b i a s) a nd p re c i s ion (rep e atab i l ity,
repro duc ib i l ity) , l i m i ts o f de te c tion a nd me a s u rement ra n ge ,
including information needed for the control of known

relevant interferences, limitations of the method and
information about the use of available reference
me a s u rement p ro ce du re s a nd m ater i a l s b y the u s er] ;
w) where releva nt, re ference i nter va l s; ISO 18113 (all parts)

x) information on interfering substances or limitations ISO 18113 (all parts)
f
(e . g. vi s u a l e vidence o hyp erl ip id aem i a o r h aemol ys i s , age o f
specimen) that can affect the performance of the IVD

me d ic a l de vice;
y) wa rn i n gs or pre c autio n s to b e ta ken i n order to fac i l i tate ISO 18113 (all parts)
the safe disposal of the IVD medical device, its accessories, IEC 61010-2-101
f
a nd the con s u m ab le s u s e d wi th it, i f a ny. T h i s i n o rm atio n
shall cover, where appropriate:

i) infection or microbial hazards (e.g. consumables ISO 18113 (all parts)
f f
conta m i n ate d with p o tenti a l l y i n e c tiou s s ub s ta nce s o IEC 61010-2-101
human origin),
ii) environmental hazards (e.g. batteries or materials that IEC 61010-2-101
em it p o tenti a l l y h a z a rdo u s le vel s o f rad i ation) , a nd
i i i) p hys ic a l h a z a rd s (e . g. e xp lo s io n) ; IEC 61010-2-101


ISO 16142-2:2017(E)

References a
z) the name, registered trade name or registered trade mark ISO 15223-1
of the manufacturer and the address of his registered place of ISO 18113 (all parts)
business at which he can be contacted and his IEC 60878
location be established, together with a telephone number or IEC 61010-2-101
fa x nu mb er or web s ite add re s s to ob tai n te ch n ic a l a s s i s tance;
aa) date of issue or revision of the instructions for use ISO 18113 (all parts)
releva nt to the p a r tic u l a r I VD me d ic a l device;
b b) a no tice to the u s er, p ro fe s s io n a l o r l ay, th at a ny s er iou s
incident that has occurred in relation to the IVD medical

device should be reported to the manufacturer and the
author ity h avi n g j u r i s d ic tion where the I VD me d ic a l de vice
wa s p u rch a s e d o r u s e d; a nd
cc) where an IVD medical device kit includes individual ISO 18113 (all parts)
reagents and articles that can be made available as separate
IVD medical devices, each such IVD medical device shall
co mp l y wi th the l ab el l i n g re qu i rements co nta i ne d i n 1 8 . 3 .
18.4 In addition, the instructions for use for the IVD medical
device intended for self-testing or near-patient testing shall
co mp l y wi th the fol lowi ng:
a) ISO 15197
de ta i l s o f the te s t p ro ce du re , i nclud i n g a ny re agent
preparation, specimen collection or preparation and ISO 17593

f ISO 18113-1
i n or m ation on how to r u n the te s t a nd re ad the re s u lts;
ISO 18113-4
ISO 18113-5
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b) 15197
our chats
the re s u lts ne e d to b e e xpre s s e d a nd p re s ente d i n a way
ISO 17593
th at i s re ad i l y u nders to o d b y the i ntende d u s er;
ISO 18113-1
ISO 18113-4
ISO 18113-5
IEC 62366-1
IEC 62366-2
c) information needs to be provided with advice to the user ISO 15197
on action to be taken (in case of positive, negative or ISO 17593
indeterminate result), on the test limitations and on the ISO 18113-1
ff
p o s s ib i l ity o f
a l s e p o s iti ve or ISO 18113-4
a l s e -ne gati ve re s u lt.
f f
I n or m atio n s h a l l a l s o b e p rovide d a s to a ny ac tors th at c a n
affect the test result (e.g. age, gender, menstruation,

i n fe c tion , e xerc i s e , fa s ti n g , d ie t or me d ic atio n) ;
d) for the IVD medical device intended for self-testing, the ISO 15197
f ISO 17593
i n or m ation p rovide d s h a l l i nclude a s tatement cle a rl y
f ISO 18113-1
d i re c ti ng th at the u s er s ho u ld no t ta ke a ny de c i s io n o
ISO 18113-4
me d ic a l rele va nce wi thout fi rs t co n s u lti ng the app ro pr i ate
he a lthc a re p ro fe s s io n a l; a nd
e) for the IVD medical device intended for self-testing used ISO 15197
for the monitoring of an existing disease, the information ISO 17593
f
s h a l l s p e c i y th at the p atient s ho u ld on l y ad ap t the tre atment ISO 18113-1
if he has received the appropriate training to do so. ISO 18113-4
B.3 Additional specific product standards
T he fol lowi ng s p e c i fic pro duc t s tanda rd s c an s upp or t the e s s enti a l pri nciple s , but have no t b e en
mapped to Table B.1 or Table B.2:

— CLSI POCT04-A2 [20] ;

ISO 1 61 42 -2 : 2 01 7(E)
— CLSI MMO3-Ed3 [21] ;
— CLSI MM06-A2 [22] ;
— CLSI MM09-A2 [23] ;
— CLSI MM12-A [24] ;
— CLSI MM16-A [25] ;
— CLSI MM17-A [26] ;
— CLSI MM22-A [27] ;
— CLSI M53-A [28] ;
— CLSI I/LA18-A2 [29] ;
— ISO 5725 (all parts) [2] ;
— ISO 16256 [6] ;
— ISO 16355 (all parts) [4] ;
— ISO 22870 [19] .

ISO 16142-2:2017(E)
Annex C
(informative)
Website listings of other standards suitable for the medical device
sector and for assessment purposes
T he fol lowi ng web s ite s contai n l i s ts o f s tandard s authoritie s with j u ri s d ic tion found s u itable for the
IVD medical device sector and for assessment purposes :

— https://ec.europa.eu/growth/single-market/european- standards/harmonised-standards/iv-
diagnostic-medical-devices_en
— http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c fStandards/search.cfm
— https://www.tga.gov.au/standards-orders-and-medical -devices
— http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-norm es/md_rec_stand_im_norm_lst-eng.php
— http://www.nicpbp.org.cn/qxbgzx/CL0490/

ISO 16142-2:2017(E)
Annex D
(informative)
Reference to the essential principles by International Standards
D.1 Purpose
Writers of standards in the healthcare sector are encouraged to use the essential principles to help
ensure that their standard addresses the appropriate high-level requirements such that an IVD medical
device, wh ich compl ie s with thei r s ta ndard, wi l l provide an appropri ate level o f s a fe ty a nd p er formance .
Standard s that fu l fi l the h igh-level re qu i rements of the e s s entia l pri nc iple s s hou ld i nclude an
i n formative an nex that map s the clau s e s and s ub cl au s e s o f the s tanda rd to the corre s p ond i ng s p e c i fic
e s s entia l pri nc iple s that they fu l fi l .
This committee, in line with practice of other ISO and IEC committees, has developed a template to
support this approach. D.2 is a template for such an annex for writers of standards where the relevant
clause/subclause numbers are entered in the second column of Table D.1 f and any relevant qua l i yi ng
remark or notes are added in the third column of the table. Rows that are not applicable should be
dele te d . T he title o f the an ne x s hou ld b e “Re ference to the e s s enti a l pri nciple s ”.
D.2 Suggested format for a reference to the essential principles annex

T h i s do c u ment ha s b e en prep a re d to s upp or t the e s s enti a l pri nciple s o f s a fe ty and p er formance of
(i n s er t typ e o f I VD me d ic a l device, pro ce s s or s er vice here) as an I VD me d ic a l device accord i ng to
I S O 16142 -2 : 2 017. T h i s do c u ment i s i ntende d to b e accep table for con form ity a s s e s s ment pu rp o s e s .
C ompl ia nce with th i s do c u ment provide s one me an s o f demon s trati ng con forma nce with the s p e ci fic
essential principles of ISO 16142-2:2017. Other means are possible. Table D.1 maps the clauses and
subclauses of this document with the essential principles of ISO 16142-2:2017.
Table D.1 — Correspondence between the essential principles and this document
Essential principle of Corresponding clause(s)/subclause(s) of
ISO 16142-2:2017, Annex B this document
Qualifying remarks/Notes
1 [list the relevant clauses and subclauses of the [indicate if this relevant essential
standard being mapped in this column] pr i nc ip le i s on l y p a r ti a l l y covere d i n
this column]
a)
b)
2
a)
b)
c)
d)
3
4
5
6
7.1

ISO 16142-2:2017(E)
Table D.1 (continued)

7.2
8.1
8.2
8.3
8.4
9.1
a)
b)
c)
9.2
9.3
9.4
9.5
10.1
10.2
10.3
10.4
11.1
11.2
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b)
c)
d)
e)
f)
g)
h)
11.3
11.4
11.5
12.1
12.2
12.3
13.1
13.2
13.2 a)
13.2 b)
14.1
15.1
15.2
15.3
15.4
16.1

ISO 16142-2:2017(E)

16.2
16.3
16.4
16.5
16.6
16.7
17.1
17.2
17.3
18.1
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
18.2
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
m)
n)
o)
p)
18.3
a)
b)
i)
ii)
iii)

ISO 16142-2:2017(E)

iv)
v)
vi)
vii)
c)
d)
e)
f)
g)
h)
i)
ii)
i)
j)
k)
l)
m)
i)
ii)
iii) Get more FREE standards from Standard Sharing Group and our chats
iv)
v)
vi)
n)
o)
p)
q)
r)
i)
ii)
iii)
iv)
s)
t)
u)
v)
w)
x)
y)
i)
ii)
iii)
z)

ISO 16142-2:2017(E)

aa)
bb)
cc)
18.4
a)
b)
c)
d)
e)

ISO 16142-2:2017(E)
Annex E
(informative)
Terminology — Alphabetized index o f defined terms
NO TE T he I S O O n l i ne B rows i ng Pl at for m (O B P) p rovide s acce s s to term s a nd de fi n itio n s

2) .
Term Source
author ity h avi n g j u r i s d ic tion 3.1
basic standard 3.2
essential principles 3.3
f f
e s s enti a l p r i nc ip le s o f 3.3
s a e ty a nd p er o r m a nce
group standard 3.4

hazard 3.5
hazardous situation 3.6
informative 3.7
intended use 3.8
in vitrodiagnostic medical device 3.10
IVD kit 3.9
IVD medical device 3.10
IVD medical deviceGetkit more FREE standards from Standard
3.9 Sharing Group and our chats
f
l i e - c ycle 3.11
manufacturer 3.12
medical device 3.13
normative 3.14
performance evaluation 3.15
process standard 3.16
product standard 3.17
post-production 3.18
residual risk 3.19
risk 3.20
risk control 3.21
risk management 3.22
state of the art 3.23
2) Available at: https://www.iso.org/obp/ui/#home

ISO 1 61 42 -2 : 2 01 7(E)
Bibliography
[1] ISO 16142-1, Medical devices — Recognized essential prin ciples of safety an d perform an ce of
medical devices — Part 1: General essential principles and additional specific essential principles for
all non-IVD medical devices and guidance on the selection o f standards
[2] ISO 5725 (all parts), Accuracy (truen ess an d precision) of m easurem ent m eth ods an d results
[3] ISO/IEC Guide 51:2014, Safety aspects — Guidelin es for th eir in clusion in stan dards
[4] ISO 16355 (all parts), Application of statistical an d related m eth ods to n ew techn ology an d product
developm ent process
[5 ] Glob a l H armon i z ation Tas k Force — Study Group 1 — E s s enti a l pri nciple s o f s a fe ty and
performance of medical devices, GHTF/SG1/N41: 2005 3)

[6] ISO 16256, Clinical laboratory testin g an d in vitro diagn ostic test system s — Referen ce m eth od
for testin g th e in vitro activity of antimicrobial agents again st yeast fun gi involved in infectious
diseases
[7] ISO/IEC Guide 2:2004, Stan dardization an d related activities — Gen eral vocabulary
[8] ISO 9001, Quality management systems — Requirements

[9] ISO 14001, Environmental management systems — Requirements with guidance for use
[10] ISO 31000, Risk m an agem ent — Prin ciples an d guidelin es
[11] ISO/IEC 17000, Con formity assessment — Vocabulary and general principles
[12] IEC 60601-1-9, Medical electrical equipment — Part 1-9: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for environmentally conscious design
[13] IEC 61010 (all parts), Sa fety requirements for electrical equipment for measurement, control, and
laboratory use
[14] ISO 20916 4) , Clinical performance studies for in vitro diagnostic devices (IVDs) using specimens
from hum an subjects — Good study practice
[15] ISO/TS 19218-1, Medical devices — Hierarchical codin g structure for adverse events — Part 1 :
Event-type codes
[16] IEC 60320, Applian ce couplers for h ouseh old an d sim ilar gen eral purposes
[17] IEC 60799, Electrical accessories — Cord sets an d intercon n ection cord sets
[18] ISO/IEC Guide 63, Guide to the development and inclusion o f sa fety aspects in International
Stan dards for m edical devices
[19] ISO 22870, Point-o f-care testing (POCT) — Requirements for quality and competence
[20] CLSI POCT04-A2, Point-o f-care in vitro diagnostic (IVD) testing; Approved guideline
[21] CLSI MMO3-Ed3, Molecular diagn ostic m eth ods for infectious diseases
[22] CLSI MM06-A2, Quantitative molecular methods for in fectious diseases; Approved guideline
3) The Glo b al H armo nizatio n Tas k Fo rce (GH TF) has b een dis s o lved and rep laced by the I nternatio nal M edical
Device Regulators Forum (IMDRF). www.imdrf.org

4) Under preparation.
ISO 1 61 42 -2 : 2 01 7(E)
[23] CLSI MM09-A2, Nucleic acid sequencing methods in diagnostic laboratory medicine; Approved
guidelin e
[24] CLSI MM12-A, Diagnostic nucleic acid microarrays; Approved guideline

[25] CLSI MM16-A, Use of external RNA controls in gene expression assays; Approved guideline
[26] CLSI MM17-A, Verification and validation of multiplex nucleic acid assays
[27] CLSI MM22-A, Microarrays for diagnosis and monitoring of in fectious diseases; Approved guideline
[28] CLSI M53-A, Criteria for laboratory testing and diagnosis of human immunodeficiency virus
in fection; Approved guideline
[29] CLSI I/LA18-A2, Specifications for immunological testing for in fectious diseases; Approved guideline
[30] IEC 60417, Graphical symbols for use on equipment

ISO 1 61 42 -2 : 2 01 7(E)
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INTERNATIONAL ISO

Medical devices — Recognized

COPYRIGHT PROTECTED DOCUMENT

ii © ISO 2017 – All rights reserved

© ISO 2017 – All rights reserved iii

iv © ISO 2017 – All rights reserved

u nders ta nd i ng o f the ne e d s a nd re qu i rements o f tho s e who u s e or who a re a ffe c te d by s ta nda rd s .

Improvements in standards will contribute to global harmonization efforts at all levels.

s tand ard s are mandator y.

te ch nolo g y, c a n b e faci l itate d by the appropriate u s e o f relevant me d ic a l device s tand ard s . T h i s i s b as e d

on the premise that

as a fundamental and effective tool for the protection of public health,

— re qu i rements and defi nition s: roman typ e;

— term s defi ne d i n Clause 3: italics.

© ISO 2017 – All rights reserved v

vi © ISO 2017 – All rights reserved

Medical devices — Recognized essential principles of

T h i s do c ument i s i ntende d for u s e a s gu id ance b y me d ic a l device ma nu fac tu rers , s tandard s development

ISO 2859 (all parts), Samplin g procedures for in spection by attributes

ISO 3951 (all parts), Samplin g procedures for in spection by variables

ISO 11137 (all parts), Sterilization of h ealth care products — Radiation

dose: Method VDmaxSD

ISO 13408 (all parts), A septic processin g of h ealth care products

© ISO 2017 – All rights reserved 1

ISO 15195, Laboratory medicine — Requirements for reference measurement laboratories

ISO 16269 (all parts),

2 © ISO 2017 – All rights reserved

IEC 62304, Medical device software — Software life cycle processes

1) Available from: Clinical and Laboratory Standards Institute, Wayne, PA US.

3 Terms and definitions

cou ntr y, j u ri s d ic tion, or a s s igne d territor y

general aspects applicable to a wide range of products, processes or services

fam i ly o f s i m i la r pro duc ts , pro ce s s e s or s er vice s

N o te 1 to entr y: Group s ta nd a rd s a re s o me ti me s re fer re d to a s s em i- ho ri z o nta l s ta nd a rd s a nd u s u a l l y app l y to

one field (s e c tor) .

4 © ISO 2017 – All rights reserved

© ISO 2017 – All rights reserved 5

6 © ISO 2017 – All rights reserved

(3.13) has been manufactured

4 Essential principles of safety and performance of IVD medical devices

5.1 General approach to using standards

8 © ISO 2017 – All rights reserved

© ISO 2017 – All rights reserved 9

Figure 1 — Types of standards

pro ce s s s tandard s a re routi nely develop e d b o th a s group o r pro duc t s ta nda rd s .

5.3 Risk management approach to demonstrating compliance

exp e c ta nc y o f e ach c an d i ffer as:

le ad i ng to h a z ardou s s ituation s are identi fie d a nd control le d i f ne ce s s ar y;

o f events le ad i ng to the ha z ardou s s ituation a re identi fie d and the ri s k i s control le d i f ne ce s s a r y;

10 © ISO 2017 – All rights reserved

5.4 Phases of the IVD medical device life-cycle

me d ic a l device, i nclud i ng e xa mple s o f I nternationa l Standard s that may b e uti l i ze d du ri ng the d i s ti nc t

ac tivitie s as s o c iate d with e ach o f the l i fe - c ycle phas e s .

mai n ly du ri ng I VD me d ic a l device de s ign a s p o s s ible te ch n ic a l s olution s to es s entia l pri nc iple s . T ho s e

s tandard s genera l ly defi ne re qu i rements wh ich, when i mplemente d, provide ri sk control me as u re s to

known hazards or hazardous situations.

pha s e s o f a me d ica l device l i fe - c ycle . T he s e s ta ndard s manage as p e c ts o f the me d ic a l device s a fe ty and

Figure 2 — Phases of the life-cycle

5.5 Use of standards during IVD medical device life-cycle phases

5.5.1 Design and development planning

of the design process.

s ys tem s , I E C 62 3 6 6 -1 on u s abi l ity and I E C 62 3 0 4 on s o ftware l i fe - c ycle pro ce s s e s re qui re that pl an s

© ISO 2017 – All rights reserved 11