Iso 13485

STD.
BSI BS EN IS0 lr3485-ENGL 2 O O L m 3624hh9 0899738 L59 W

BRITISH STANDARD BS EN I S 0
13485:2001
Quality systems -
Medical devices -
Particular
requirements for the
application of
EN I S 0 9001 (revision
of EN 46001:1996)
(identical to
I S 0 13485:1996)
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The European StandardEN IS0 13485:2000has the statusof a

British Standard
ICs 03.120.10;11.040.01
NO COPYING WITHOUTBSI PERMISSION EXCEPTAS PERMITTED BY COPYRIGHT LAW

Copyright European Committee for Standardization
Provided by IHS under license with CEN Licensee=Underwriters Laboratories Inc /5909636100
No reproduction or networking permitted without license from IHS Not for Resale, 11/08/2006 11:26:52 MST
National foreword
of
This British Standardis the official English language version
EN IS0 134852000. It is identical withIS0 134851996. It supersedes
BS EN 46001:1997 which will be withdrawn on 15 February 2004.
The UK participation in its preparation was entrusted Technical
to Committee
CH/66, Quality systemsfor manufacture of medical devices, which has the
responsibility to:
- aid enquirers to understand the text;

- present to the responsible internationallEuropean committee any
enquiries on the interpretation,or proposals for change, and keep the
UK interests informed;
monitor related international and Europeandevelopments and
promulgate them in theUK.
A list of organizations represented on this committee can be obtained on

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request to its secretary.

Cross-references
Attention is drawn to thefact that CEN and CENELEC Standards normally
include an annex which lists normative references to international
publications with their corresponding European publications. The British
Standards which implement these international or European publications may
be found in theBSI Standards Catalogue under thesection entitled
“International Standards Correspondence Index”, or by using the “Find”
facility of the BSI Standards Electronic Catalogue.
A British Standarddoes not purport to include all the necessary provisions of
a contract. Usersof British Standards are responsible for their correct
application.
Compliance witha British Standard does notof itself confer immunity
f r o m legal obligations.
Summary of pages
been British
This prepared underthe having This document comprises a front cover, an insidefront cover, the EN IS0 title
direction ofthe Health and page, the EN IS0 foreword page, the Is0 title page, pages ii to iv, pages 1
Environment Sector to 10,the annex ZA page and a back cover.
Committee, was published
under the aunority of the The BSI copyright date displayed in this document indicates when the
Standards Committee and document was last issued.
comes into effect on
15 March 2001
Amendments issued since publication
Amd. No. Date Comments
O BSI 03-2001
ISBN O 680 36992 7

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STD.BSI BS E N IS0 13485-ENGL 2001 M Lb24669 0899720 807 m
EUROPEANSTANDARD EN IS0 13485

NORME EUROPÉENNE
EUROPÄISCHE NORM November 2000
ICs 03.120.10;11.040.01
English version
Quality systems - Medical devices - Particular requirementsfor

the application of EN IS0 9001 (revision of EN 46001 :1996)
(identical to IS0 13485:1996)
- -
Systemes qualit6 Dispositifs medicaux Exigences Qualit$ttssicherungssysteme- Medizinprodukte Besondere-
particuli6res relativesA l'application de I'EN
I S 0 9001 Anforderungen für die Anwendung von EN I S 0 9001
(r6vision de I'EN 46001 :1996) (identiqueB I'ISO (Uberprüfung der EN 46001:1996) (identisch mit IS0
13485:1996) 134831996)
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This European Standard was approved
by CENKENELEC on 1 April 2000.
CENKENELEC members are boundto comply with the CEWCENELEC lntemal Regulations which stipulate the conditions for giving
this
European Standard the status
of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may
be obtained on application to
the Management Centre orto any CENKENELEC member.
This European Standard exists in three official versions (English, French, German). A version
in any other language made by translation
under the responsibilityof a CEN/CENELEC memberinto its own language and notified to the Management Centre has the same status as
the offlcial versions.
CENKENELEC members are the national standards bodies and national electrotechnical committees, respectively, of Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands,
Noway, Portugal, Spain,
Sweden, Switzerland and United Kingdom.
CENELEC
CEN Management Centre: CENELEC Central Secretariat:
rue de Stassart, 36 8-1050 Brussels rue de Stassart, 35 8-1050 Brussels
Q 2000 CENKENELEC All rightsof exploitation in any form andby any means reserved Ref. No. EN IS0 13485:2000 E
worldwide for CEN national Members and for CENELEC
Members.

Foreword
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Thetext of theInternationalStandardfromTechnicalCommitteeISO/TC210"Quality
managementandcorrespondinggeneralaspectsformedicaldevices"oftheInternational
Organization for Standardization (ISO) has been taken over as an European Standard by
Technical Committee CENKENELEC "Coordinating working group on quality supplements",
the secretariat of which is held by DIN.
This European Standard supersedes EN46001:1996.
This European Standard shall be given the status of a national standard, eitherby publication
of an identical text or by endorsement, at the latest by May 2001, and conflicting national
standards shall be withdrawn at the latest by February 2004.
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s).
According to the CENKENELEC Internal Regulations, the national standards organizations

of the following countries are bound to implement this European Standard: Austria, Belgium,
CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The textof the International StandardIS0 13485: 1996
has been approved by CEN/CENELEC
as a European Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).

STDmBSI BS EN IS0 13485-ENGL 2 O O L m Lb24bb90899722 b8T m
EN IS0 13486:2000
INTERNATIONAL IS0
STANDARD 13485
First edition
1996-12-1 5
Quality systems Medical devices - -

Particular requirements for the application
of IS0 9001
Systdmes qualit6 Dispositifs ddjcaux - -fxjgences particulieres
relatives A l'application de I'ISO 9001
Reference number
I S 0 13485:1996(E)
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STD-BSI BS EN IS0 L3485-ENGL 2OOL m L b 2 4 b b 9 0899723 5Lb
EN IS0 13486:2000
1 $cope ............................................................................................ 1
2 Normativereferences .................................................................... 1
3 .. ......................................................................................
Definltlons 1
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4 Qualitysystemrequirements ......................................................... 3
4.1 Management responsibility ................................................. 3
4.2 Quality system .................................................................... 3
4.3 contract review .................................................................. 3
4.4 Design control .................................................................... 3
46 Document and data control ................................................ 4
4.6 Purchasing ......................................................................... 5
4.7 C o n t r o l of customer-supplied product ................................ 5
4.8 Product identification and traceability ................................. 5
4.9 Pracess control .................................................................. 6
4.10 Inspection and testing ........................................................ 7
4.1 1 Control of inspection. measuring and test equipment ........ 7
4.12 Inspection and test status .................................................. 7
4.13 Control of nonconforming product...................................... 8
4.1 4 Corrective and preventive action ........................................ 8
4.1 5 Handling, storage, packaging, preservation and delivery .. 9
4.16 Control of q u a l ¡ records ................................................... 9
4.17 Intemalq u a l ¡ audi ......................................................... 10
4.1 8 Training .............................................................................. 10
4.19 Senricing ............................................................................. 10
420 Statistical techniques .......................................................... 10

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STD-BSI BS EN IS0 13485-ENGL 2001 m 1b24bb9 0899724 452 9

EN IS0 13486:2000
Foreword
IS0 (theIntemationalOrganizationforStandardization)is a worldwide
federation of national standards bodies (IS0 member bodies). The work of
preparingIntemationalStandards is normallycarriedoutthrough IS0
technical committees. Each member body interestedin a subject for which
a technical committee has been established has thetoright be represented
onthatcommittee.Intemationalorganizations,governmentalandnon-
governmental, inliaisonwith SO, alsotakepart in thework. IS0
collaboratescloselywiththeIntemationalElectrotechnicalCommission
(IEC) on all matters of electrotechnical standardization.
Draft IntemationalStandardsadoptedbythetechnicalcommitteesare
circulated to the member bodies for voting. Publication as an Intemational
Standard requires approvalby at least 75 % of the member bodies casting
a vote.
Intemational Standard IS0 13485 was prepared by Technical Committee

lSO/TC 210, Quality management and corresponding general aspects for
medical devices.
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Introduction
IS0 9001 isageneralstandarddefiningqualitysystemrequirements.
IS0 13485 providesparticularrequirementsforsuppliersof medical
devices that are more specific than the general requirements specified in
IS0 9001.
In
conjunctionwith IS0 9001, this
International
Standard
defines
requirementsforqualitysystemsrelating to thedesigddevelopment,
production, installation and servicing of medical devices.
It embraces all the
principlesofgoodmanufacturingpractice (GMP) widelyused in the
manufacture of medical devices. It can only be used in combination with
IS0 9001 and is not an independent standard.
There are a wide variety of medical devices and some of the particular
requirements of this Intemational Standard only apply to named groups of
medical devices. These groups are described in clause 3.
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Other International Standards specify more detailed particular requirements

that are additional to those specified here. Suppliers should review the
requirementsandconsiderusingtherelevantIntemationalStandards in
these areas.
Toassist in the understanding of therequirementsofthisInternational

Standard, an international guidance standard is being prepared.

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S T D * B S I BS EN IS0 13485-ENGL 2 0 0 1 W 1b24bb90899726 225

EN IS0 13486:ZOOO
- -
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Quality systems Medical devices Particular

requirements forthe application of IS0 9001
1 Scope
I This
Intemational
Standardspecifies, in conjunction with IS0 9001, the
quality
system requirements
for
the
~ desigddeveloprnent,productionand,whenrelevant,installationandServicingofmedicaldevices.
This Intemational Standard, in conjunction with IS0 9001, is applicable when thereis a need to assess a medical
device supplier's quality system.
As part of an assessment by a third party for the purpose

of regulatory requirements, the supplier may be required
to provide access to confidential data in order to demonstrate compliance with this Intemational Standard. The
supplier may be required to exhibit these data but is not obliged to provide copies for retention.
NOTE - In this International Standard the termi

f
' appropriate" is used several times. When a requirement is qualified by this
phrase, W is deemed to be"appropriate"unlessthesuppliercandocument a justificationotherwise. A requirementis
considered "appropriate"if its non-implementation could result in
- the product not meeting its specified requirements, and/or
- the supplier being unableto carry out corrective action.
2 Normative references
Thefollowingstandardscontainprovisionswhich,throughreference in thistext,constituteprovisionsofthis
Intemational Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision,andparties to agreementsbasedonthisIntemationalStandardareencouragedtoinvestigatethe
possibility of applying the most recent editions of the standards indicated below. Members IEC
of and IS0 maintain
registers of currently valid Intemational Standards.
- Vocabulary.
IS0 8402:1994, Quality management and quality assurance
IS0 9001 :1994,Quality systems - Model for qualityassutance in design, development, production, installation and
servicing.
IS0 11 137:1995,Sterilization of healthcare products- Requirements for validation and mutine control- Radiation
sterilization.
3 Definitions
For the purposes of this Intemational Standard, the definitions givenin IS0 8402 apply, with the exception that the
definition of "product" as givenin IS0 9001 applies. In addition, the following definitions apply.
NOTE - These definitions should be regarded as generic,

as definitions provided in national regulations may differ slightly.
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STD-BSI BS EN IS0 L3485-ENGL 2001 m Lb24669 0899727 L b 3 m

EN IS0 13486:2000
3.1 medical device: Any instrument, apparatus, appliance, material or other article, whether used alone or in
combination, including the software necessary for its proper application, intended by the manufacturer tobe used
for human beings for the purpose
-
of
-
diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
andwhichdoesnotachieve its principalintendedactioninoronthehumanbodybypharmacological,

immunological or metabolic means, but which may be assisted in its function by such means.
NOTE -
In addition to the medical device categories defined hereinafter, the term "medical device-also includes non-active
medical devices andin vitro diagnostic devices.
3.2 activemedicaldevice:Anymedicaldevice(see3.1)relyingforitsfunctioningonasourceofelectrical
energy or any source of power other than that directly generated by the human body or gravity.
3.3 active implantable medical device: Any active medical device (see 3.1 and 3.2) which is intended to be
totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural
orifice, and whichis intended to remain after the procedure.
3.4 implantable medicaldevice: Any medical device (see 3.1) intended

- to be totally or partially introduced into the human body or a natural orifice, or
- to replace an epithelial surface or the surface of the eye,
by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which can
only be removed by medical or surgical intervention.
NOTE - This definition applies to implantable medical devices other than active implantable medical devices.
3.5 sterik medlcal device: Any medical device labelled as sterile. (See 3.6.1 ofIS0 11 137:1995.)
NOTE -
Requirementsforlabellingamedicaldevice as sterile may be subject to national or regionalregulationsor
standards.
3.6 labelling: Written, printed or graphic matter

- of its containers or wrappers, or
affixed to a medical device or any
- accompanying a medical device,
of the medical device, but excluding shipping documents.

related to identification, technical description and use
NOTE -
For the purposes of this International Standard, the term 'marking" as used in IS0 9001 is interpreted to mean
labelling".
3.7 cu.tomsr complaint: Any written, electronic or oral communication that alleges deficiencies related to the
identity, quality, durability, reliability, safety or performance of a medical device ( s e e 3.1) that has been placed on
the market.
3.8 advisory n o t k Notice issued by the supplier, subsequent to delivery of the medc
ial device, to provide
supplementary information andlorto advise what action should be taken in
- the use of a medical device,
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EN IS0 13485:2000
- the modification of a medical device,

- the retum to the supplierof a medical device,
- the destruction of a medical device,
forthepurposeofcorrectiveorpreventiveactionand in compliancewithnationalandregionalregulatory
requirements.
4 Quality system requirements

4.1 Managementresponsibility
The requirements givenin 4.1 of IS0 9001:1994 apply.
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4.2 Qualitysystem
4.2.1
General
The requirements given in 4.2.1 ofIS0 9001:1994 apply.
t for all medical devices;
The supplier shall establish and document the specified requirements.
NOTE - If this International Standard is used for compliance with regulatory requirements, the relevant requirementsof
the regulations should be included in the specified requirements.
4.2.2 Quality system procedures
The requirements givenin 4.2.2 of IS0 9001 :1994 apply.
4.2.3 Qualityplanning
IS0 9001 :1994 apply.

The requirements given in 4.2.3 of
P a r t i c u l a r e m e n t for all medical devices;
The supplier shall establish and maintain a file containing documents defining product specifications and quality
system requirements (process and quality assurance) for
- completemanufacturing,and
- installation and servicing,if appropriate,
for each type/model of medical device,or referring to the location(s)

of this information (see 4.5.2 and 4.16).
4.3 Contractreview
The requirements givenin 4.3 of IS0 9001 :1994 apply.
4.4 Designcontrol
4.4.1
General
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STD.BS1 BS EN IS0 13485-ENGL 2001 L b 2 4 b b 9 0899729 T 3 4 W

EN IS0 13485:2000
for devi-a;
Throughout the design process, the supplier shall evaluate the needfor risk analysis and maintain records of
any risk analyses performed.
4.4.2 Design and development planning
4.4.3 Organizational and technical interfaces
4.4.4 Design Input
4.4.5Designoutput
The requirements givenin 4.4.5 of IS0 9001:1994 apply.
4.4.6Designreview
4.4.7Designverification
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4.4.8Designvalidation
for mdevice=
As part of design validation, the supplier shall perform and maintain
records of clinical evaluations.
NOTE- Clinical evaluation may include a compilation of relevant scientific literature, historical evidence that similar
designs andlor materials are clinically safe, or a clinical investigation or trial, to ensure that the device performs as
intended. Nationalor regional regulations may require actual clinical investigations or trials.
4.4.9Designchanges
4.5 Document and data control
4.5.1
General
4.59 Document and data approval andissue
4
devices;
The supplier shall define the period for which at least one copy of obsolete controlled documents shall be
retained. This period shall ensure that specifications to which medical devices have been manufactured are
available for at least the lifetime of the medical device as defined by the supplier.
4.5.3 Document and data changes
4.6 Purchasing
4.6.1 General
4.6.2 Evaluation of subcontractors
The requirements given in 4.6.2 ofIS0 9001 :1994 apply.
4.6.3 Purchasingdata
The requirements given in 4.6.3of IS0 9001 :1994 apply.
To the extent required by the particular requirements for traceability given

in 4.8, the supplier shall retain copies
(see 4.16) of relevant purchasing documents.
4.6.4 Verification of purchased product
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4.7 Control of customer-supplied product
4.8 Product identification and traceability
ParticuLgr r e e
Identification
a)
Thesuppliershallestablishandmaintainprocedures toensurethatmedicaldevicesreturnedtothe
supplier for reprocessing to specified requirements are identified and distinguished at all times from norma
production (see 4.15.1).
Traceability
b)
Thesuppliershallestablish,documentandmaintainproceduresfortraceability.Theproceduresshall
define the extentof traceability and shall facilitate corrective and preventive action (see 4.14).
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EN IS0 13486:2000
When defining the extent of traceability, the supplier shall include all components and materials used and
records of the environmental conditions [see 4.9 b) 4)] when these could cause the medical device not to
satisfy its specified requirements.
The supplier shall require thatits agents or distributors maintain records of the distribution of medical devices
with regard to traceability and that such records are available for inspection.
4.9 Process control
The requirements givenin 4.9 of I S 0 9001:1994 apply.
Personnel
The supplier shall establish, document and maintain requirements for health, cleanliness and clothing of
personnel if contact between such personnel and the product or the environment could adversely affect the
quality of the product.
Thesuppliershallensurethat allpersonnel whoarerequiredto work temporarilyunderspecial
environmental conditions are appropriately trained
or supervised by a trained person (see 4.18).
Environmental controlin manufacture

For medical devices
1) that are supplied sterile, or

2) that are supplied non-sterile and intended for sterilization before use, or
3) if themicrobiologicaland/orparticulatecleanlinessorotherenvironmentalconditionsareof
significance in their use,or
4) if the environmental conditions are of significancein their manufacture,
thesuppliershallestablishanddocumentrequirementsfortheenvironmenttowhichtheproductis
exposed.
If appropriate, the environmental conditions shall
be controlled and/or monitored.
Cleanliness of product
The supplier shall establish, document and maintain requirements for the cleanliness of the product if
1) product is cleaned by the supplier prior to sterilization and/or

its use, or
2) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use,
or
3) product is suppliedto be used non-sterile and its cleanliness
of significance
is in use, or
4) process agents are to be removed from product during manufacture.
If appropriate, product cleaned in accordance with 1) or 2) above need not be subject to the preceding
particularrequirements[¡.e.a)Personnel,and b) Environmentalcontrolinmanufacture]priortothe
cleaning procedure.
Maintenance
The supplier shall establish and document requirements for maintenance activities when such activities
may affect product quality.
Records of such maintenance shall be kept (see 6).
4.1
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Installation
If appropriate,thesuppliershallestablishanddocumentbothinstructionsandacceptancecriteriafor
installing and checking the medical device.
Records of installation and checking performed by the supplier or its authorized representative shall be
retained (see 4.16).
If the contract (see 4.3) allows installation other than by the supplier or its authorized representative, the
supplier shall provide the purchaser with written instructions for installation and checking.
Computer software usedin process control

The supplier shall establish and maintain documented procedures for the validation of the application of
computersoftwarewhich is usedforprocesscontrol.Theresultsofthevalidationshall berecorded
(see 4.16).
t for s W e medical device%
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The supplier shall subject the medical device to a validated sterilization process and record (see 4.16) all the
control parameters of the sterilization process.
4.10 Inspection and testing
4.10.1
General
The requirements given in 4.10.1of IS0 9001:1994 apply.
4.10.2 Receiving inspection and testing
4.10.3 In-process inspection and testing
4.1 0.4 Final inspection and testing
4.10.5 Inspection and test records
The requirements given in 4.10.5of IS0 9001:1994 apply.
r reqummot for activeu & m W l e m e w devlces

1 and
The supplier shall record (see 4.16) the identity of personnel performing any inspection or testing.
4.1 1 Control of inspection, measuring and test equipment
The requirements givenin 4.1 1 of IS0 9001:1994 apply.
4.12 Inspection and test status

7
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EN IS0 13486:2000
4.13 Control of nonconforming product
4.13.1
General
The requirements givenin 4.1 3.1 of IS0 9001:I

994 apply.
4.13.2 Review and diaposition of nonconforming product
The requirements given in 4.1 3.2 IS0

of 9001 :1994 apply.
Thesuppliershallensurethatnonconformingproductisacceptedbyconcessiononly if regulatory
requirements are met. The identity of the person@) authorizing the concession be
shallrecorded (see 4.16).
If productneeds to be reworked(one or moretimes),thesuppliershalldocumenttherework in awork

instruction that has undergone the same authorization and approval procedure as the originalwork instruction.
Prior to authorization and approval,a determination of any adverse effect of the rework upon product shall be
made and documented.
4.1 4 Corrective and preventive action
4.14.1
General
P a r t i c u l a r t s for ahnedical devices

The supplier shall establish and maintain a documented feedback system to provide early warningof quality
problems and for input into the corrective and/or preventive action system.
If this International Standard is usedfor compliance with regulatory requirements which require the supplier to
gain experience from the post-production phase, the review of this experience shall form part of the feedback
system.
The supplier shall maintain records (see 4.16) ofall customer complaint investigations. When the investigation
determines that the activities at remote premises contributed to the customer complaint, relevant information
shall be communicated between the supplier and the remote premises.
If any customer complaint is not followed by corrective and/or preventive action, the reason shall be recorded.
Ifthis International Standard is used for compliance with regulatory requirements, the supplier shall establish,
document and maintain procedures to notify the regulatory authority of those incidents which meet the reporting
criteria.
The supplier shall establish, document and maintain procedures for the issue of advisory notices for medical
devices. These procedures shallbe capable of being implemented at any time.
4.14.2Cormctiveaction
4.1 4.3 Preventive action
The requirements givenin 4.1 4.3 of IS0 9001:I

994 apply.
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EN IS0 13485:2000
4.15 Handling, storage, packaging, preservation and delivery
The supplier shall establish and maintain documented procedures for the control of product with a limited shelf-
life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded
(see 4.16).
If appropriate, special arrangements shall be established, documented and maintained for the control of used
product in order to prevent contamination of other product, the manufacturing environment or personnel.
4.1 5.2 Handling
The requirements givenin 4.15.2 Of Is0 9001 A994 apply.
4.15.3 Storage
5.3 of IS0 9001 :1994 apply.

m e requirements given in 4.1
4.15.4
Packaging
Is0 9001 :1994 apply.

The requirements given in 4.1 5.4 of
4.15.5 Preservation
The requirements givenin 4.15.5 of Is0 9001:1994 apply.
4.15.6
Delivery
The requirements givenin 4.1 5.6 of IS0 9001 :1994 apply.
ent for=tive m a l devlces andm

- edciacles;
The supplier shall ensure that the name and address of the shipping package consignee is included in the
quality records (see 4.16).
4.16 Control of quality records
P a r t W a m u h m n t s for ahndd devices;
The supplier shall retain the quality records for a period of time at least equivalent
to the lifetime of the medical
device as defined by the supplier, but not less than
2 years from the date of despatch from the supplier.
NOTE 1 National or regional regulations may requirea period longer than 2 years.
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The supplier shall establish and maintain a record for each batch of medical devices that provides traceability to
the extent specified in 4.8 and identifies the quantity manufactured and quantity approved for distribution. The
batch record shall be verified and authorized.
NOTE 2 A batch may be a single medical device.
4.17 Internal quality audits

of IS0 9001:1994 apply.
The requirements given in 4.17
4.18
Training
4.19 Servicing
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4.20 Statisticaltechniques
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EN IS0 13485:2000
Annex ZA (normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in itby
amendment or revision. For undated references the latest edition of the publication referred
to applies.
PublicationYearTitle EN
I S 0 8402
1994
Quality
management
and
quality
EN I S 0 8402
1995
assurance - Vocabulary
I S 0 9001
1994
Quality
systems - Modelfor
quality
EN I S 0 9001
1994
assurance in desigddevelopment,
production, installation and servicing
--`,,,`,,,``,,`,`,````,````,,`-`-`,,`,,`,`,,`---

~~~~~~ ~
STD*BSI BS EN IS0 13485-ENGL 2001 D 1621.1669 0899737 O00 m

BS EN I S 0
13485:2001
BSI - British Standards Institution
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or
editions.
It is the constant aimof BSI to improve the quality of our productsand services.
We would be grateful if anyone finding an inaccuracy or ambiguity while using
this British Standard would inform the Secretary of the technical committee
--`,,,`,,,``,,`,`,````,````,,`-`-`,,`,,`,`,,`---
responsible, the identityof which can be found on the inside frontcover.

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STD.

BSI BS EN IS0 lr3485-ENGL 2 O O L m 3624hh9 0899738 L59 W

The European StandardEN IS0 13485:2000has the statusof a

NO COPYING WITHOUTBSI PERMISSION EXCEPTAS PERMITTED BY COPYRIGHT LAW

- aid enquirers to understand the text;

A list of organizations represented on this committee can be obtained on

request to its secretary.

Amendments issued since publication

Amd. No. Date Comments

ISBN O 680 36992 7

Copyright European Committee for Standardization

STD.BSI BS E N IS0 13485-ENGL 2001 M Lb24669 0899720 807 m

EUROPEANSTANDARD EN IS0 13485

Quality systems - Medical devices - Particular requirementsfor

Copyright European Committee for Standardization

This European Standard supersedes EN46001:1996.

According to the CENKENELEC Internal Regulations, the national standards organizations

Copyright European Committee for Standardization

Quality systems Medical devices - -

Copyright European Committee for Standardization

Copyright European Committee for Standardization

STD-BSI BS EN IS0 13485-ENGL 2001 m 1b24bb9 0899724 452 9

Intemational Standard IS0 13485 was prepared by Technical Committee

Other International Standards specify more detailed particular requirements

Toassist in the understanding of therequirementsofthisInternational

Copyright European Committee for Standardization

S T D * B S I BS EN IS0 13485-ENGL 2 0 0 1 W 1b24bb90899726 225

Quality systems Medical devices Particular

As part of an assessment by a third party for the purpose

NOTE - In this International Standard the termi

NOTE - These definitions should be regarded as generic,

STD-BSI BS EN IS0 L3485-ENGL 2001 m Lb24669 0899727 L b 3 m

andwhichdoesnotachieve its principalintendedactioninoronthehumanbodybypharmacological,

3.4 implantable medicaldevice: Any medical device (see 3.1) intended

3.6 labelling: Written, printed or graphic matter

of the medical device, but excluding shipping documents.

- the use of a medical device,

Copyright European Committee for Standardization

STD.BSI BS EN IS0 13485-ENGL 2001 m Lb24bb9 0899728 O T B m

- the modification of a medical device,

4 Quality system requirements

The requirements givenin 4.1 of IS0 9001:1994 apply.

The requirements given in 4.2.1 ofIS0 9001:1994 apply.

t for all medical devices;

The supplier shall establish and document the specified requirements.

4.2.2 Quality system procedures

The requirements givenin 4.2.2 of IS0 9001 :1994 apply.

IS0 9001 :1994 apply.

P a r t i c u l a r e m e n t for all medical devices;

for each type/model of medical device,or referring to the location(s)

The requirements givenin 4.3 of IS0 9001 :1994 apply.

The requirements given in 4.4.1 ofIS0 9001:1994 apply.

STD.BS1 BS EN IS0 13485-ENGL 2001 L b 2 4 b b 9 0899729 T 3 4 W

4.4.2 Design and development planning

The requirements givenin 4.4.2 of IS0 9001 :1994 apply.

4.4.3 Organizational and technical interfaces

The requirements givenin 4.4.3 of IS0 9001 :1994 apply.

4.4.4 Design Input

The requirements givenin 4.4.4 of IS0 9001 :1994 apply.

The requirements givenin 4.4.5 of IS0 9001:1994 apply.

The requirements givenin 4.4.6 of IS0 9001 :1994 apply.

The requirements givenin 4.4.7 of IS0 9001 :1994 apply.

The requirements givenin 4.4.8 of IS0 9001 :1994 apply.