Iso 15223-1-2016

INTERNATIONAL ISO
STANDARD 15223-1
Third edition
2016-11-01
Corrected version
2017-03
Medical devices — Symbols to be used

with medical device labels, labelling
and information to be supplied —
Part 1:
General requirements
Dispositifs médicaux — Symboles à utiliser avec les étiquettes,
l’étiquetage et les informations à fournir relatifs aux dispositifs
médicaux —
Partie 1: Exigences générales
Reference number
ISO 15223-1:2016(E)
I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

© ISO 2016
ISO 15223-1:2016(E)
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ii
ISO 15223-1:2016(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................ iv
Introduction .................................................................................................................................................................................................................................. v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 General requirements ..................................................................................................................................................................................... 2
4. 1 Pro p o s al o f symb o ls f ........................................................................................................................................... 2
o r ado p tio n
4.2 Requirements for usage .................................................................................................................................................................. 2

4. 3 .......................................................................................................................................................................................... 3
O ther symb o ls
5 Symbols .......................................................................................................................................................................................................................... 3
Annex A (informative) Examples ........................................................................................................................................................................... 20
Annex B (informative) Use of general prohibition symbol and negation symbol............................................... 24
Bibliography ............................................................................................................................................................................................................................. 25
© ISO 2016 – All rights reserved

iii
ISO 15223-1:2016(E)
Foreword
I SO (the I nternational O rganiz ation for Standardiz ation) is a worldwide federation of national s tandards
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 b een es tablished has the right to b e represented on that committee. I nternational
organi zation s , governmental and non- governmental, in liaison with I SO, al so take p ar t in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f
elec trotechnical s tandardi z ation.
T he procedures used to develop this do cument and those intended for its fur ther maintenance are
describ ed in the I SO/I E C D irec tives , Par t 1 . I n p ar ticu lar 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 ru les of the I SO/I E C D irec tives , Par t 2 (see www. iso . org/direc tives) .
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 I SO l is t of p atent declarations received (see www. iso . org/p atents) .
Any trade name used in this document is in formation given for the convenience o f users and does not
cons titute an endors ement.
For an explanation on the meaning o f ISO specific terms and expressions related to con formity assessment,
as well as information about I SO ’s adherence to the World Trade O rganization ( WTO) principles in the
Technical B arriers to Trade (TB T ) see the following URL: www.iso.org/iso/foreword. html .
T he com mittee res p ons ible for this document is I SO/ TC 2 10 , Quality m an agem ent an d correspon din g
gen eral aspects for m edical devices.
T his third edition cancel s and replaces the second edition (I SO 1 52 2 3 -1 : 2 01 2 ) , which has b een
technically revised with the following principal revisions:

— C laus e 2 , up dated the title of I S O 70 0 0 and added the “date of release” for each of the regis tered
symbols to Table 1 ;
— symbol 5.1.1, modified the requirement related to the placement o f the manu facturer’s name and
addres s on I VD lab els;
— symbol 5.1.2, modified the requirement related to the placement o f name and address o f the
authorized representative in the Europ ean Union on I VD lab el s;
— symbol 5.4.3, added the in formation used to indicate an instruction to consult an electronic
ins truc tions for use (eI F U ) ;
— symbol 5.4.5, added the re ference to ISO 7000, symbol 2725, “Contains or presence o f”;
— symbol 5.5.5, modified the description o f the symbol and the requirement regarding use with IVD;
— A.1 5 , added the examples of the placement of the eI F U indicator.
A lis t of al l p ar ts in the I SO 1 52 2 3 series can b e found on the I SO webs ite.
NOTE Future symbols intended to appear in this document are to be validated in accordance with
I S O 1 5 2 2 3 -2 .
T his correc ted vers ion of I S O 1 52 2 3 -1 : 2 016 incorp orates the fol lowing correc tion:
— in A.9 , the graphical symbol o f NOTE 2 has been corrected.
iv
ISO 15223-1:2016(E)
Introduction
This document addresses the presentation o f certain items o f in formation that are considered by
regulatory authorities to be essential for the sa fe and proper use o f medical devices. As such, the items
are required to appear with the medical device in most regulatory domains. The in formation can be
required to appear on the medical device itself, as part of the label, or provided with the medical device.
Many countries require that their own language be used to display textual in formation with medical
devices. At the same time, manu facturers seek to take costs out o f labelling by reducing or rationalizing
variants. This can cause problems in relation to translation, design and logistics when multiple
languages are included on a single label or piece of documentation. For example, users of medical
devices labelled in a number o f di fferent languages can experience con fusion and delay in locating the
appropriate language.
This document proposes solutions to these problems through the use o f internationally recognized
symbols with precisely defined descriptions.
While compiling symbols to be included in this document, ISO/TC 210 recognized the need for systematic
methodology for the selection, development and validation o f symbols proposed for adoption. This is
the subject o f ISO 15223-2.
This document is primarily intended to be used by manu facturers o f medical devices who market
identical products in countries where there are different language requirements for medical device
labelling. It can also be of assistance to
— distributors of medical devices or other representatives of manufacturers,
— healthcare providers responsible for training, as well as those being trained,
— those responsible for post-market vigilance,
— healthcare regulatory authorities, testing organizations, certification bodies and other organizations
which are responsible for implementing regulations affecting medical devices and which have
responsibility for post-market surveillance, and
— consumers or end users of medical devices who draw their supplies from a number of sources and
can have varied language capabilities.

v
INTERNATIONAL STANDARD ISO 15223-1:2016(E)
Medical devices — Symbols to be used with medical device

labels, labelling and information to be supplied —
Part 1:
General requirements
1 Scope
This do c u ment identi fie s re qu i rements for s ymb ol s used in me d ic a l device lab el l i ng that convey
i n formation on the s a fe and e ffe c tive u s e o f me d ic a l device s . I t a l s o l i s ts s ymb ol s th at s ati s fy the
requirements of this document.

This do c u ment i s appl ic ab le to s ymb ol s used in a bro ad s p e c tru m o f me d ic a l device s , wh ich are
marke te d glob a l ly a nd there fore ne e d to me e t d i fferent regu lator y re qu i rements .
T he s e s ymb ol s may be used on the me d ic a l device its el f, on its p ackagi ng or in the as s o c iate d
do c u mentation . T he re qui rements o f th i s do c u ment are no t i ntende d to apply to s ymb ol s s p e ci fie d i n
other standards.
2 Normative references
T he fol lowi ng do c u ments are re ferre d to i n the tex t i n s uch a way th at 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 7000 1) , Graphical symbols for use on equipment — Registered symbols

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information
to be supplied — Part 2: Symbol development, selection and validation
3 Terms and definitions

For the pu rp o s e s o f th i s do c ument, the term s and defi n ition s given i n I S O 149 71 and the fol lowi ng apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
characteristic information
i n formation that repre s ents the prop er ty or prop er tie s o f a s ymb ol
1) f
The co llectio n o I S O 7 0 0 0 grap hical symb o ls and additio nal in fo rmatio n co ncerning their us e are availab le at
https://www.iso.org/obp/ui/#search . E ach symb o l in the datab as e has a “regis tratio n date”. Thes e dates are given
in the ISO Registration Number column in Table 1.

1
ISO 15223-1:2016(E)
3.2
description
normative text which defines the purpose, application and use o f the symbol
[SOURC E: I EC 8 0 416 -1 : 2 0 0 8 , 3 . 2 ]
3.3
label
written, printed or graphic information provided up on the medical device itsel f
[SOURC E: GH TF/S G1/N43 : 2 0 0 5 ]
3.4
labelling
in formation supplied by the manu facturer that is provided for, associated with, or a ffixed to, a medical
device or any o f its containers or wrappers
Note 1 to entry: This in formation relates to the identification, technical description (3 . 2 ) and us e of the me dic a l
device, but excludes sh ippi ng do cuments .
Note 2 to entry: Some regional and national regulations re fer to “labelling” as “in formation supplied by the
manu fac tu rer ”.
3.5
symbol used in medical device labelling
graphical representation app earing on the label (3 . 3 ) and/or as so ciated documentation of a medical
device that communicates ch aracteristic inform ation (3 .1) without the need for the s uppl ier or receiver
of the information to have knowledge of the language of a p ar ticular nation or p eople
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar
objects, including alphanumeric characters.
3.6
title
unique name by which a graphical symbol is identified and spoken o f
[SOURC E: I EC 8 0 416 -1 : 2 0 0 8 , 3 .9]
4 General requirements
4.1 Proposal of symbols for adoption

Symbols proposed for adoption in this document shall be validated in accordance with ISO 15223-2.
Any symbol proposed for adoption in this document shall be applicable to a range o f medical devices
and have global or regional applicability.
4.2 Requirements for usage

When risk management shows it to be appropriate for symbols to be used to convey in formation
es sential for prop er use on the medical device, its p ackaging or in as sociated documentation, the
symbols given in Table 1 may be used.
2
ISO 15223-1:2016(E)
Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000,
especially with respect to relative dimensions, including relative line thickness, orientation and the
absence or presence o f filled or shaded areas.
NOTE 1 ISO and IEC jointly maintain an online database o f graphical symbols for use on equipment, which
contains the complete set o f graphical symbols included in ISO 7000 and IEC 60417 available at https://www.
iso.org/obp/ui/#search . This online collection shows each graphical symbol and identifies it by a reference
number and a title (in English and French). The graphical symbols are available in di fferent formats (e.g. AI, DWG,
EPS) and some additional data as applicable is provided. Various search and navigation facilities allow for easy
retrieval o f graphical symbols.
As part o f risk management, the manu facturer should determine the appropriate size for the symbol to
be legible for its intended function.
NOTE 2 This document does not speci fy colours or minimum size for the symbols in Table 1 , nor does it speci fy
the relative size o f symbols and that o f indicated in formation.
It is important that symbols be used properly. Guidance on appropriate use o f the general prohibition
symbol and the negation symbol is given in Annex B.
Be fore symbols are used, the manu facturer shall carry out a risk assessment that indicates that the use
o f the symbol does not introduce an unacceptable risk.
NOTE 3 Additional information regarding risk assessment can be found in ISO 14971.
Symbols may be used without accompanying text. Where regulations require accompanying text, the
title o f the symbol given in this document should be considered su fficient. All dates and times presented
in association with symbols shall use the conventions set out in ISO 8601.
4.3 Other symbols

Other standards speci fy additional symbols that are applicable to particular kinds or groups o f
medical devices or to particular situations. Examples o f sources for such symbols are identified in the
Bibliography. This listing is not exhaustive.
5 Symbols
When appropriate, information essential for proper use shall be indicated on the medical device, its
packaging, or in the associated documentation by using the corresponding symbols given in Table 1.
A manu facturer may use any appropriate symbol regardless o f category.
NOTE Table 1 has been organized into symbol categories for ease o f use. The category into which a symbol is
grouped does not have any significance as far as usage is concerned. The order o f appearance o f symbols and the
categories in which they are placed are not prioritized. Examples o f the use o f symbols can be found in Annex A.

3
Table 1 — Symbols to convey information essential for proper use

4
ISO 15223-1:2016(E)
Reference Description of Informative Restrictions of Additional ISO 7000
number of Title of symbol symbol Requirements notes use requirements Reg. no.
symbol a
5.1 Manufacture
5.1.1 M a nu fac tu rer I nd i c ate s the me d ic a l T h i s s ym b o l s h a l l b e NO TE 1 T h i s s ym b o l i s u s e d to 3 0 82
de vice m a nu fac tu rer, a s ac c o m p a n i e d b y the n a m e i nd i c ate i n fo r m atio n th at i s

2 0 1 1-10 - 0 2
de fi ne d i n a nd add re s s o f the re qu i re d i n E u ro p e . b
E U D i re c ti ve s 9 0/3 8 5/ m a nu fac tu r er (i . e . the
E E C , 9 3/42 / E E C a nd p er s o n p l ac i n g the me d ic a l
NO TE 2 T he fu l l de fi n i ti o n o f
“m a nu fac tu rer ” i s g i ven i n E U

9 8/7 9/ E C . de vi ce o n the m a rke t) ,
D i re c ti ve s 9 0/3 8 5/ E E C , 9 3/42 / E E C
adj ac e n t to th e s ym b o l .
a nd 9 8/7 9/ E C .
NO TE 3 G u i d a nce o n the
re qu i rements fo r E U D i re c ti ve s
9 0/3 8 5/ E E C a nd 9 3/42 / E E C i s
gi ven i n E N 10 41 .
NO TE 4 G u i d a nce o n the
re qu i rements fo r E U D i re c ti ve
9 8/7 9/ E C i s g i ve n i n I S O 1 8 1 1 3 -1 ,
I S O 1 8 1 1 3 -2 , I S O 1 8 1 1 3 - 3 ,
I S O 1 8 1 1 3 - 4 a nd I S O 1 8 1 1 3 - 5 .
NO TE 5 T he d ate o f m a nu fac tu re ,
a s we l l a s the n a me a nd add re s s o f
the m a nu fac tu rer, c a n b e co mb i ne d
i n o ne s y m b o l .
NO TE 6 T he rel ati ve s i z e o f the
s y m b o l a n d th e s i z e o f th e n a m e a n d
add re s s a re no t s p e c i fi e d .
Table 1 (continued)
Reference
Description of Informative Restrictions of Additional ISO 7000
number of Title of symbol Requirements
symbol notes use requirements Reg. no. a
symbol
5.1.2 Authorized Indicates the authorized T h i s s ym b o l s h a l l b e NO TE 1 T h i s s ym b o l i s u s e d to N/A

representative in the representative in the indicate information that is
ac c o m p a n i e d b y the n a m e
European and address of the

E u ro p e a n C o m mu n i t y. required in the European Commu-
C o m mu n i t y authorized representative n i t y.
in the European NOTE 2 Guidance on the

requirements for EU Directives
C o m mu n i t y, adj ac e nt to th e
s ymb ol .
90/385/EEC and 93/42/EEC is
given in EN 1041.
NOTE 3 Guidance on the
requirements for EU Directive
98/79/EC is given in ISO 18113-1,
ISO 18113-2, ISO 18113-3,
ISO 18113-4 and ISO 18113-5.
NOTE 4 The relative size of the
s y m b o l a n d the s i z e o f the n a m e a n d
add re s s a re no t s p e c i fi e d .
ISO 15223-1:2016(E)
5
Table 1 (continued)
6
ISO 15223-1:2016(E)
Reference
symbol
5.1.3 D ate o f I nd i c ate s the d ate when T h i s s ym b o l s h a l l b e NO TE T he rel ati ve s i z e o f the I n E u ro p e: b 2 49 7
m a nu fac tu re the me d i c a l de vi ce wa s ac c o m p a n i e d b y a d ate s y m b o l a n d the s i z e o f the d ate a re

— the d ate co u ld b e a 2 0 0 4 - 0 1-1 5
m a nu fac tu re d . to i nd i c ate the d ate o f no t s p e c i fi e d .
ye a r, ye a r a n d m o n th , o r
m a nu fac tu r e . T h i s s h a l l b e
ye a r, m o n th a n d d ay, a s
e x p re s s e d a s i n I S O 8 6 0 1
re qu i re d i n the rel e va nt
as fo u r d igits fo r th e ye a r
E U D i re c ti ve;
a nd , where ap p ro p r i ate ,
two d i gi ts fo r the mo nth

— th i s s y m b o l m ay
a n d t wo d i g i t s fo r th e d ay.
b e u s e d to i de n ti fy
th e m o nth a nd ye a r o f
T he d ate s h a l l b e l o c ate d
m a nu fac tu re fo r ac ti ve
i mp l a ntab le me d i c a l
de vi c e s , o r th e ye a r o f
m a nu fac tu re fo r ac ti ve
me d i c a l de vic e s where
no u s e - b y d ate i s g i ve n ,
a s re qu i re d b y th e ap -
p ro p r i ate E U D i r e c ti ve .
Table 1 (continued)
Reference
symbol
5.1.4 U s e - b y d ate Indicates the date after NOTE 1 For example, June 2002 is
T h i s s ym b o l s h a l l b e In Europe: b 2607
which the medical expressed as 2002-06.
ac c o m p a n i e d b y a d ate to
— the date could be a 2004-01-15
device is not to be used. indicate that the medical NOTE 2 The relative size of the
device should not be used f s y m b o l a n d the s i z e o the d ate a re
ye a r, ye a r a n d m o n th , o r
ye a r, m o n th a n d d ay, a s
a fte r th e e n d o f th e ye a r,
no t s p e c i fi e d . re qu i re d b y th e
m o n th o r d ay s ho w n .
relevant
The date shall be NO TE 3 S y no ny m fo r “u s e - b y d ate ”
EU Directive;
expressed as in ISO 8601 i s “u s e b y ”.
asf f
o ur d igits
and, where appropriate,

o r th e ye a r
NOTE 4 For some medical devices — th i s s y m b o l c a n b e
u s e d to i de n ti fy th e ti me
two digits for the month (e . g. I VD s) , th i s d ate i s o n l y va l i d
when the medical device is limit for implanting

unopened. an active implantable
a n d t wo d i g i t s fo r th e d ay.
medical device
The date shall be located s a fe l y a s re q u i re d
adj ac e n t to th e s ym b o l . b y E U D i re c ti ve 9 0/ 3 8 5/
EEC.
5.1.5 Batch code Indicates the NOTE 1 The relative size of the
T h i s s ymb ol s h a l l b e 2492
manufacturer’s batch ac c o m p a n i e d b y the f s y m b o l a nd the s i z e o the b atc h
2004-01-15
code so that the batch or manufacturer’s batch code. c o de a re no t s p e c i fi e d .
The batch code shall be

lo t c a n b e i de n ti fi e d .
f NO TE 2 S y no n ym s o r “ b atc h
code” are “lot number” and “batch

number”.
ISO 15223-1:2016(E)
7
Table 1 (continued)
8
ISO 15223-1:2016(E)
Reference
symbol
5.1.6 C ata lo g ue nu m b er I nd i c ate s the T he m a nu fac tu rer ’s NO TE 1 T he re l ati ve s i z e o f the I n E u ro p e , b the 2 493
m a nu fac tu rer ’s c ata lo g ue nu mb er s h a l l b e s y m b o l a n d the s i z e o f the c at a lo g ue m a nu fac tu rer ’s

2 0 0 4 - 0 1-1 5
c ata l o g ue nu m b er s o adj ac e n t to th e s ym b o l . nu m b e r a re no t s p e c i fi e d . c ata l o g ue nu m b er s h a l l
th at the me d ic a l de vice b e p l ace d a fter o r b e lo w
c a n b e i de n ti fi e d .
NO TE 2 S y no ny m s fo r the s y m b o l a n d adj ac e n t
“c ata lo g ue nu mb er ” a re
to i t . T h i s s ym b o l m ay
“re ference nu mb er ” a nd
c u r re n tl y b e s h o w n
“re o rder nu mb er ”.
wi tho ut the enclo s u re;
ho we ver, i t i s i ntende d
th at th i s o p tio n b e
wi thd r awn i n a futu re
e d i ti o n o f th i s do c u ment.
5.1.7 S er i a l nu m b er I nd ic ate s the T h i s s ymb ol s h a l l b e NOTE T he re l ati ve s i z e o f the I n E u ro p e , b the 2 49 8
m a nu fac tu rer ’s s er i a l ac c o mp a n i e d b y th e s ym b o l a n d th e s i z e o f th e s e r i a l m a nu fac tu rer ’s s er i a l

2 0 0 4 - 0 1-1 5
nu m b e r s o th at a s p e c i fi c m a nu fac tu rer ’s s er i a l nu m b e r a re n o t s p e c i fi e d . nu mb er s h a l l b e p l ace d
me d i c a l de vice c a n b e nu mb er. T he s er i a l nu mb er a fter o r b el ow the
i de n ti fi e d . s h a l l b e adj ac e n t to th e s ym b o l a nd adj ac e n t to
s ym b o l . i t . T h i s s ymb o l m ay c u r -
re n tl y b e s ho w n w i tho u t
the encl o s u re; ho we ver,
i t i s i ntende d th at th i s
o p ti o n b e wi thd rawn i n
a futu re e d itio n o f th i s
do c u ment.
Table 1 (continued)
Reference
symbol
5.2 Sterility
5.2 .1 Sterile Indicates a medical NO TE U s e o f th i s s y m b o l In Europe, b this 2499

device that has been p re c lude s th e u s e o f s y m b o l s 5 . 2 . 2 s ym b o l i s re s t r i c te d to
2004-01-15
s ub j e c te d to a to 5.2.5. u s e o n te r m i n a l l y
sterilization process. sterilized medical

devices
(EN 556-1:2001, 4.1
applies, including its
associated note).
5.2 .2 Sterilized using Indicates a medical NOTE 1 Aseptic techniques can 2500
aseptic processing device that has been i nc l ude fi l tr ati o n .
2004-01-15
techniques manufactured using
accepted aseptic NOTE 2 U s e o f th i s s y m b o l
techniques. p re c l ud e s th e u s e o f s ym b o l 5 . 2 . 1 .
5.2 .3 Sterilized using Indicates a medical NOTE U s e o f th i s s ym b o l p re - In Europe, b th i s s ym b o l 2501

e th yl e ne o x i de device that has been c lude s th e u s e o f s y m b o l 5 . 2 . 1 . is restricted to use on 2004-01-15
s te r i l i z e d u s i n g e th yl e ne te r m i n a l l y s te r i l i z e d
oxide. medical devices

(EN 556-1:2001, 4.1
associated note).
5.2 .4 Sterilized using Indicates a medical NOTE 1 T h i s s ymb ol c a n b e In Europe, b th i s s ym b o l 2502

irradiation device that has been used to indicate that the product is restricted to use on 2004-01-15
sterilized using h a s b e e n s ub j e c te d to i r rad i ati o n te r m i n a l l y s te r i l i z e d
irradiation. processes. medical devices
ISO 15223-1:2016(E)
(EN 556-1:2001, 4.1
NOTE 2 U s e o f th i s s y m b o l
p re c l ud e s th e u s e o f s ym b o l 5 . 2 . 1 .
associated note).
9
Table 1 (continued)
10
ISO 15223-1:2016(E)
Reference
symbol
5.2 .5 S ter i l i z e d u s i n g s te a m I nd i c ate s a me d i c a l NO TE U s e o f th i s s y m b o l I n E u ro p e , b th i s s ym b o l 2 503
o r d r y he at de vice th at h a s b e en p re c lude s th e u s e o f s y m b o l 5 . 2 . 1 . i s re s tr ic te d to u s e o n
2 0 0 4 - 0 1-1 5
s ter i l i z e d u s i n g s te a m o r te r m i n a l l y s te r i l i z e d
d r y h e at. me d ic a l de vice s
( E N 5 5 6 -1 : 2 0 0 1 , 4 . 1
ap p l ie s , i nclud i n g i ts
a s s o c i ate d no te) .
5.2 .6 D o no t re s ter i l i z e I nd ic ate s a me d ic a l 2 60 8
de vice th at i s no t to b e
2 0 0 4 - 0 1-1 5
re s ter i l i z e d .
5.2 .7 N o n- s ter i le I nd ic ate s a me d ic a l T h i s s y m b o l s h o u ld o n l y 2 60 9
de vice th at h a s no t b e en b e u s e d to d i s ti n g u i s h
2 0 0 4 - 0 1-1 5
s ub j e c te d to a b e twe en identic a l o r
s ter i l i z ati o n p ro ce s s . s i m i l a r me d ic a l de vice s
s o ld i n b o th s ter i l e a nd
no n- s ter i l e co nd i tio n s .
5.2 .8 D o no t u s e i f p acka ge I nd ic ate s a me d ic a l NOTE T h i s s ym b o l m ay a l s o m e a n I n E u ro p e , b th i s s y m b o l 2606
i s d a m a ge d de vice th at s ho u ld no t “D o no t u s e i f the p ro duc t s ter i le s h a l l b e e x pl a i ne d i n the

2 0 0 4 - 0 1-1 5
b e u s e d i f the p ackage b a r r i e r s ys te m o r i ts p ac ka g i n g i s i n fo r m ati o n s up p l i e d b y
h a s b e en d a m a ge d o r co mp ro m i s e d”. the m a nu fac tu rer.
o p ene d .
Table 1 (continued)
Reference
symbol
5.2 .9 S te r i l e flu i d p ath Indicates the presence of The method of sterilization In Europe, b th i s s y m b o l 3084
-
a s te r i l e flu i d p ath w i th shall be indicated in the shall be explained in the 2011-10-05
in the medical device in e mp t y b o x , a s ap p ro p r i ate . f
i n o r m ati o n s up p l i e d b y
cases when other parts The part of the medical the manufacturer.
of the medical device, device that is sterile shall
including the exterior,
might not be supplied b e i de n ti fi e d i n th e
sterile. i n fo r m ati o n s up p l i e d b y
the manufacturer.
5.3 Storage
5.3.1 Fragile, handle with Indicates a medical 0621

care device that can be 2014-06-04
broken or damaged if not
h a n d le d c a re fu l l y.
5.3.2 Ke e p away fro m Indicates a medical NOTE T h i s s ym b o l c a n a l s o m e a n 0624

sunlight device that needs “Ke e p away fro m h e at”, a s
2014-06-04
protection from light referenced in ISO 7000.
sources.
5.3.3 Protect from heat and Indicates a medical NOTE T h i s s ym b o l c a n a l s o m e a n In Europe, b th i s s y m b o l 0615
radioactive sources device that needs shall be explained in the
ISO 15223-1:2016(E)
protection from heat and
“Ke e p away fro m
radioactive sources”.
s u n l ight and
f
2004-01-15
radioactive sources. the manufacturer.
11
Table 1 (continued)
12
ISO 15223-1:2016(E)
Reference
symbol
5.3 .4 Ke e p d r y I nd i c ate s a me d i c a l NO TE T h i s s y m b o l c a n a l s o me a n 0 62 6
de vice th at ne e d s to “Ke e p away fro m ra i n” a s

2 0 14 - 0 6 - 0 4
b e p ro te c te d fro m reference d i n I S O 70 0 0 .
mo i s tu re .
5.3 .5 L o wer l i m i t o f temp er- I nd i c ate s the lo wer l i m i t T he l o wer l i m i t o f temp er- 053 4
atu re o f temp er atu re to wh ich atu re s h a l l b e i nd i c ate d

2 0 0 4 - 0 1-1 5
the me d i c a l de vi ce c a n adj ac e n t to th e lo we r
b e s a fe l y e x p o s e d . ho r i z o nta l l i ne .
5.3 .6 Up p er l i m i t o f I nd i c ate s the up p er l i m i t T he up p er l i m i t o f temp er- 0533
temp eratu re o f temp er atu re to wh ich atu re s h a l l b e i nd i c ate d

2 0 0 4 - 0 1-1 5
the me d i c a l de vi ce c a n adj ac e n t to th e up p e r
b e s a fe l y e x p o s e d . ho r i z o nta l l i ne .
5.3 .7 Temp eratu re l i m i t I nd i c ate s the T he up p er a nd l o wer l i m i ts 0632
temp er atu re l i m i ts o f temp eratu re s h a l l b e

2 0 14 - 0 6 - 0 4
to wh ich the me d ic a l i n d i c ate d adj ac e n t to the
de v i c e c a n b e s a fe l y up p er a nd lo wer ho r i z o nta l
exposed. l i ne s .
Table 1 (continued)
Reference
symbol
5.3 .8 H um id i ty Indicates the range of T he hu m i d i t y In Europe, b th i s s y m b o l 2620

limitation hu m i d i t y to wh i c h the limitation shall be shall be explained in the 2004-01-15
medical device can be i n d i c ate d adj ac e n t to the f
s a fe l y e x p o s e d . upper and lower horizontal the manufacturer.

lines.
5.3.9 Atmospheric Indicates the range of The atmospheric pressure In Europe, b th i s s y m b o l 2621
pressure atmospheric pressure limitations shall be shall be explained in the 2004-01-15
limitation to which the medical i n d i c ate d adj ac e n t to th e f
f
de v i c e c a n b e s a e l y upper and lower horizontal the manufacturer.
exposed. lines.
5.4 Safe use
5.4.1 Biological risks Indicates that there NOTE See ISO 7010.
T h i s s ym b o l i s 0659
are potential biological not to be confused with 2004-01-15
risks associated with the the “Biohazard” sign
medical device. intended to be used in the
workplace.
5.4.2 Do not re-use Indicates a medical NOTE S y no ny m s fo r “D o no t re - 1051

device that is intended u s e ” a re “s i n gl e u s e ” a n d “u s e o n l y
2004-01-15
for one use, or for use on once”.
a single patient during a
ISO 15223-1:2016(E)
single procedure.
13
Table 1 (continued)
14
ISO 15223-1:2016(E)
Reference
symbol
5.4.3 C o n s u l t i n s tr uc tio n s I nd i c ate s the ne e d fo r NO TE 1 S y no ny m fo r “C o n s u l t W hen u s e d to i nd ic ate 1 6 41
fo r u s e the u s er to co n s u l t the i n s tr uc ti o n s fo r u s e” i s “C o n s u l t a n i n s tr uc tio n to co n s u l t

2 0 0 4 - 0 1-1 5
i n s tr uc tio n s fo r u s e . o p er ati n g i n s tr uc ti o n s ”. a n e le c tr o n ic i n s tr uc-
ti o n s fo r u s e (eI F U ) , th i s
NO TE 2 C o n s ider the d i fference
s ym b o l i s ac c o mp a n i e d
b e t we en the de s c r ip tio n o f th i s
b y a n e I F U i n d i c ato r.
s y m b o l a n d th at o f s y m b o l 5 . 4 . 4 .
T h i s i n d i c ato r m ay
rep r e s ent the m a nu fac-
tu rer ’s eI F U we b s i te o r
a n y o th e r ap p ro p r i ate
i nd ic ati o n o n the u s e
o f eI F U . T he i nd ic ato r
m ay b e p l ac e d e i th e r
a lo n gs ide , b ene ath o r
s u r ro u n d i n g th e s y m b o l
(s e e A . 1 5 ) .
5.4.4 C au tio n I nd i c ate s the ne e d fo r T he s y m b o l va r i a n t NO TE 1 C o n s ider the d i fference T h i s s y m b o l i s no t to b e 0 43 4 A
the u s er to co n s u l t the I S O 70 0 0 , s ym b o l 0 43 4B b e t we en the de s c r ip tio n o f th i s co n fu s e d wi th the

2 0 0 4 - 0 1-1 5
i n s tr uc tio n s fo r u s e fo r (“C au ti o n” ) m ay b e u s e d . s y m b o l a n d th at o f s y m b o l 5 . 4 . 3 . “C au tio n” s i gn i ntende d
i mp o r t a n t c auti o n a r y to b e u s e d i n the
NO TE 2 T h i s s ym b o l i s e s s e n ti a l l y
i n fo r m ati o n s uch a s wo rkp l ace .
a c au ti o n a r y s ym b o l a n d i s u s e d
wa r n i n gs a nd
to h i gh l i ght the fac t th at there a re
p re c auti o n s th at c a n no t,
s p e c i fi c wa r n i n gs o r p r e c au ti o n s
fo r a va r i e t y o f re a s o n s ,
a s s o c i ate d wi th the me d i c a l de vi ce ,
b e p re s ente d o n the
wh ich a r e no t o ther wi s e fo u nd o n
me d ic a l de vice i ts el f.
the l ab el .
Table 1 (continued)
Reference
symbol
5.4.5 Contains or presence Indicates the presence NO TE T h i s s y m b o l i s i n te n de d In Europe, b

T h i s s y m b o l s ho u l d th i s s y m b o l Application of
of natural rubber latex f
o n at u r a l r u b b e r o r d r y to wa r n th o s e p e o p le wh o m ay not be used for medical shall be explained in the I S O 70 0 0 , s y m b o l
natural rubber latex as a have allergic reactions to certain devices containing f i n o r m ati o n s up p l i e d b y 2725
material of construc- proteins in latex. the manufacturer.
“s y n th e ti c r ub b e r ”.
2005-09-08
tion within the medical
device or the packaging
of a medical device.
5 . 5 I V D - s p e c i fi c
5.5.1 diagnostic
In vitro Indicates a medical In Europe, b
T h i s s y m b o l s h o u ld o n l y th i s s y m b o l N/A
medical device device that is intended b e u s e d to i d e n ti fy in i s o n l y u s e d to i de n ti fy in
to be used as an in vitro vitro diagnostic medical diagnostic medical

vitro
diagnostic medical devices and not to d e vi c e s a s de fi ne d i n E U
device. f Directive 98/79/EC.

s p e c i y th at th e m e d i c a l
device is for “ in vitro
use”.
5.5.2 Control Indicates a control NOTE For negative controls, use N/A
material that is intended s ym b o l 5 . 5 . 3 a n d fo r p o s i ti ve
NOTE ISO 7000-2494
f f -
to ve r i y the p e r o r c o n tro l s , u s e s ym b o l 5 . 5 . 4 .
mance characteristics of wa s w i th d raw n b y
ISO/TC 145/SC 3.
another medical device. Letters and words
are not registered as
grap h i c a l s y m b o l s i n
ISO 7000.
5.5.3 Negative control Indicates a control 2495

material that is intended 2004-01-15
f
to ve r i y th e re s u l ts i n
the expected negative
ISO 15223-1:2016(E)
range.
15
Table 1 (continued)
16
ISO 15223-1:2016(E)
Reference
symbol
5.5.4 Po s i ti ve co ntro l I nd i c ate s a c o ntro l 2 49 6
m ater i a l th at i s i ntende d
2 0 0 4 - 0 1-1 5
to ve r i fy th e re s u l ts i n
the e x p e c te d p o s i ti ve
ra n ge .
5.5.5 C o nt a i n s s u ffi c i e n t fo r I nd i c ate s the to ta l T he nu mb er o f te s ts th at NO TE T he rel ati ve s i z e o f the Ap p l ic atio n o f
< n > te s ts nu mb er o f I VD te s ts th at c a n b e p er fo r me d wi th the s y m b o l a n d the nu m b e r o f te s t s I S O 70 0 0 , s ymb ol
c a n b e p er fo r me d wi th I V D s h a l l ap p e a r adj ac e n t p e r fo r m e d c a n va r y. 0 51 8
the I V D . to th e s ym b o l .
2 0 0 4 - 0 1-1 5
Table 1 (continued)
Reference
symbol
5.5.6 For IVD performance Indicates an IVD device NOTE 1 A synonym is “IVD for This symbol shall not Application of
evaluation only that is intended to be investigational use only”. appear jointly on the ISO 7000, symbol
used only for evaluating
NOTE 2 A medical device that is of label or in the labelling 3083
its performance for IVD performance evaluation an IVD device bearing 2011-10-03
characteristics before it the symbol
is placed on the market only is not intended to be used for
an diagnostic examination
for medical diagnostic in vitro
use. for medical purposes (i.e. to yield

diagnostic results).
which means that the

medical device is an in
vitro diagnostic medical
device intended by the
manufacturer to be used
for an in vitro diagnostic
examination.
5.6 Transfusion/infusion
5.6.1 Sampling site Indicates a medical NOTE This is not to be associated In Europe, b this symbol 2715
device or blood with a site on a patient where shall be explained in the 2005-09-08
processing application samples are taken. in formation supplied by
that includes a system the manufacturer.
dedicated to the collec-
tion of samples of a given
ISO 15223-1:2016(E)
substance stored in the
medical device or blood
container.
17
Table 1 (continued)
18
ISO 15223-1:2016(E)
Reference
symbol
5.6.2 F l u i d p ath I nd i c ate s the p re s ence o f I n E u ro p e , b th i s s y m b o l 2722
a flu i d p ath . s h a l l b e e x pl a i ne d i n the

2005 -09-08
i n fo r m ati o n s up p l i e d b y
the m a nu fac tu rer.
5.6.3 N o n - p y ro ge n i c I nd ic ate s a me d ic a l I n E u ro p e , b th i s s y m b o l 2724
de vice th at i s s h a l l b e e x pl a i ne d i n the
2005 -09-08
n o n - p y ro ge n i c . i n fo r m ati o n s up p l i e d b y
the m a nu fac tu rer.
5.6.4 D ro p s p e r m i l l i l i tre I nd ic ate s the nu mb er o f NOTE T he nu m b er o f d ro p s p er I n E u ro p e , b th i s s y m b o l 2726
d ro p s p er m i l l i l i tre . m i l l i l i tre i s s p e c i fi e d ; 2 0 i s s h o w n s h a l l b e e x pl a i ne d i n the

2005 -09-08
a s a n e xa mp l e a nd wi l l b e rep l ace d i n fo r m ati o n s up p l i e d b y
b y th e ap p ro p r i ate nu m b e r o f d ro p s the m a nu fac tu rer.
p er m i l l i l i tre .
5.6.5 L i qu i d fi l te r w i th p o re I nd ic ate s a n i n fu s i o n NOTE T he no m i n a l p o re s i z e o f the I n E u ro p e , b th i s s y m b o l 2727
size o r tra n s fu s i o n s ys te m fi l te r i s s p e c i fi e d ; 1 5 i s s ho w n a s a n s h a l l b e e x pl a i ne d i n the

2005 -09-08
o f the me d ic a l de vice e x a m p le a n d w i l l b e re p l ac e d b y the i n fo r m ati o n s up p l i e d b y
th at c o n ta i n s a fi l te r o f ap p r o p r i ate p o re s i z e . the m a nu fac tu rer.
a p a r tic u l a r no m i n a l
p o re s i z e .
Table 1 (continued)
Reference
symbol
5.6.6 One-way valve Indicates a medical NOTE It is important for the user In Europe, b this symbol 2728
device with a valve that to know that the flow is only shall be explained in the 2005-09-08
allows flow in only one possible in one direction and cannot in formation supplied by
direction. be reversed. the manufacturer.
5.7 Others
5.7.1 Patient number Indicates a unique In Europe, b this symbol 2610

number associated with shall be explained in the 2004-01-15
an individual patient. in formation supplied by
the manufacturer.
a Each symbol in the ISO/IEC symbols database (available at https://www.iso.org/obp/ui) has a “registration date”. This date is shown below the Registration Number.
b At the moment, only countries applying the principles laid down in the EU Directives have this requirement or restriction.
ISO 15223-1:2016(E)
19
ISO 15223-1:2016(E)
Annex A
(informative)
Examples
A.1 Example of use of symbol 5.1.1, “Manufacturer”
Name Address
A.2 Example of use of symbol 5.1.1, “Manufacturer”, combined with 5.1.3, “Date of
manufacture”
Name Address 2015-06
A.3 Example of use of symbol 5.1.2, “Authorized representative in the European

Community”
Name Address
A.4 Examples of use of symbol 5.1.3, “Date of manufacture”
2015
2015-06
20
ISO 15223-1:2016(E)
A.5 Examples of use of symbol 5.1.4, “Use-by date”
2015-06
2015-06-15
A.6 Example of use of symbol 5.1.5, “Batch code”
ABC123
A.7 Example of use of symbol 5.1.6, “Catalogue number”
ABC123
A.8 Example of use of symbol 5.1.7, “Serial number”
ABC123
A . 9 E xa m p l e s o f
u s e o f
s ym b o l s f
o r “ S te r i l e fl u i d p a th ”
NO TE 1 M e d ic a l de vice conta i n s a s ter i le flu id p ath th at h a s b e en s ter i l i z e d u s i n g e thylene oxide .

21
ISO 15223-1:2016(E)
NO TE 2 M e d ic a l de vice conta i n s a s ter i le flu id p ath th at h a s b e en s ter i l i z e d u s i n g i r rad i atio n .
NO TE 3 M e d ic a l de vice conta i n s a s ter i le flu id p ath th at h a s b e en s ter i l i z e d u s i n g s te a m or d r y he at.
A.10 Examples of use of symbols for temperature limits
Upper limit of Lower limit of Temperature

temperature temperature limit
A.11 Examples of use of symbol 5.3.8, “Humidity limitation”
A.12 Example of use of symbol 5.3.9, “Atmospheric pressure limitation”
A.13 Examples o f use o f symbol 5.5.5, “Contains sufficient for < n > tests”
22
ISO 15223-1:2016(E)
A.14 Example of use of symbol 5.7.1, “Patient number”
ABC123
A.15 Example of use of symbol 5.4.3, “Consult instructions for use” for an
electronic instruction for use (eIFU)
eIFU indicator
eIFU indicator
NOTE The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that
the instructions for use are available in an electronic format.

23
ISO 15223-1:2016(E)
Annex B
(informative)
Use of general prohibition symbol and negation symbol
B.1 General prohibition symbol

The general prohibition symbol (as used in ISO 3864-1) is intended to indicate a prohibited action. For
medical device lab el l ing, the prohibition circle with a diagonal b ar shou ld b e used to mean “do not”,
e.g. symbol 5.4.2 “Do not re-use”. It is sometimes used out o f context in medical device labelling, e.g.
to mean “do es not contain”. I t is imp or tant that us age b e cons is tent with the intended meaning so that
haz ards do not aris e from mis unders tanding.
B.2 Negation symbol

Manu facturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing
this meaning do es not exis t, should fol low the metho d set out in I E C 8 0 416 -3 : 2 0 02 , C lause 7 (a large “X”
placed over the symbol). Although it is not generally recommended that this symbology be used with
any o f the symbols given in this document, the use o f the negation symbol is permitted.
24
ISO 1 5 2 2 3 -1 : 2 01 6(E)
Bibliography
[1] ISO 3864-1, Graphical symbols — Safety colours and safety signs — Part 1: Design principles for
safety signs and safety markings
[2] ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs
[3] ISO 14971, Medical devices — Application of risk management to medical devices
[4] ISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling) — Part 1: Terms, definitions and general requirements
[5] ISO 18113-2 2) , In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling) — Part 2: In vitro diagnostic reagents for professional use
(labelling) — Part 3: In vitro diagnostic instruments for professional use
(labelling) — Part 4: In vitro diagnostic reagents for self-testing
(labelling) — Part 5: In vitro diagnostic instruments for self-testing
[9] IEC 60417, Graphical symbols for use on equipment
[10] IEC 80416-1, Basic principles for graphical symbols for use on equipment — Part 1: Creation of
graphical symbols for registration
[11] IEC 80416-3:2002, Basic principles for graphical symbols for use on equipment — Part 3: Guidelines
for the application of graphical symbols
[12] EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be
designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices
[13] EN 1041, Information supplied by the manufacturer of medical devices
[14] GHTF/SG1/N43. 2005, Labelling for medical devices. Available at: http://www.imdrf.org/docs/
f /sg1/technical-docs/ghtf-sg1-n43-2005-labelling-medical-devices-050603.pdf
ght /fi na l
2) Cancels and replaces EN 375:2001.

25
ISO 15223-1:2016(E)
I C S 0 1 . 0 8 0 . 2 0 ; 1 1 . 0 4 0 . 0 1
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INTERNATIONAL ISO

Medical devices — Symbols to be used

I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n

COPYRIGHT PROTECTED DOCUMENT

4.2 Requirements for usage .................................................................................................................................................................. 2

© ISO 2016 – All rights reserved

gen eral aspects for m edical devices.

technically revised with the following principal revisions:

A lis t of al l p ar ts in the I SO 1 52 2 3 series can b e found on the I SO webs ite.

— in A.9 , the graphical symbol o f NOTE 2 has been corrected.

© ISO 2016 – All rights reserved

Medical devices — Symbols to be used with medical device

i n formation on the s a fe and e ffe c tive u s e o f me d ic a l device s . I t a l s o l i s ts s ymb ol s th at s ati s fy the

requirements of this document.

marke te d glob a l ly a nd there fore ne e d to me e t d i fferent regu lator y re qu i rements .

do c u mentation . T he re qui rements o f th i s do c u ment are no t i ntende d to apply to s ymb ol s s p e ci fie d i n

ISO 7000 1) , Graphical symbols for use on equipment — Registered symbols

3 Terms and definitions

in the ISO Registration Number column in Table 1.

[SOURC E: GH TF/S G1/N43 : 2 0 0 5 ]

of the information to have knowledge of the language of a p ar ticular nation or p eople

4.1 Proposal of symbols for adoption

4.2 Requirements for usage

symbols given in Table 1 may be used.

4.3 Other symbols

© ISO 2016 – All rights reserved

Table 1 — Symbols to convey information essential for proper use

de vice m a nu fac tu rer, a s ac c o m p a n i e d b y the n a m e i nd i c ate i n fo r m atio n th at i s

E U D i re c ti ve s 9 0/3 8 5/ m a nu fac tu r er (i . e . the

“m a nu fac tu rer ” i s g i ven i n E U

the m a nu fac tu rer, c a n b e co mb i ne d

NO TE 6 T he rel ati ve s i z e o f the

5.1.2 Authorized Indicates the authorized T h i s s ym b o l s h a l l b e NO TE 1 T h i s s ym b o l i s u s e d to N/A

European and address of the

in the European NOTE 2 Guidance on the

5.1.3 D ate o f I nd i c ate s the d ate when T h i s s ym b o l s h a l l b e NO TE T he rel ati ve s i z e o f the I n E u ro p e: b 2 49 7

m a nu fac tu re the me d i c a l de vi ce wa s ac c o m p a n i e d b y a d ate s y m b o l a n d the s i z e o f the d ate a re

two d i gi ts fo r the mo nth

and, where appropriate,

two digits for the month (e . g. I VD s) , th i s d ate i s o n l y va l i d

when the medical device is limit for implanting

The batch code shall be

code” are “lot number” and “batch

m a nu fac tu rer ’s c ata lo g ue nu mb er s h a l l b e s y m b o l a n d the s i z e o f the c at a lo g ue m a nu fac tu rer ’s

th at the me d ic a l de vice b e p l ace d a fter o r b e lo w

wi thd r awn i n a futu re

5.1.7 S er i a l nu m b er I nd ic ate s the T h i s s ymb ol s h a l l b e NOTE T he re l ati ve s i z e o f the I n E u ro p e , b the 2 49 8

m a nu fac tu rer ’s s er i a l ac c o mp a n i e d b y th e s ym b o l a n d th e s i z e o f th e s e r i a l m a nu fac tu rer ’s s er i a l

me d i c a l de vice c a n b e nu mb er. T he s er i a l nu mb er a fter o r b el ow the

the encl o s u re; ho we ver,

5.2 .1 Sterile Indicates a medical NO TE U s e o f th i s s y m b o l In Europe, b this 2499

sterilization process. sterilized medical

5.2 .3 Sterilized using Indicates a medical NOTE U s e o f th i s s ym b o l p re - In Europe, b th i s s ym b o l 2501

oxide. medical devices

5.2 .4 Sterilized using Indicates a medical NOTE 1 T h i s s ymb ol c a n b e In Europe, b th i s s ym b o l 2502

irradiation. processes. medical devices

5.2 .5 S ter i l i z e d u s i n g s te a m I nd i c ate s a me d i c a l NO TE U s e o f th i s s y m b o l I n E u ro p e , b th i s s ym b o l 2 503

5.2 .6 D o no t re s ter i l i z e I nd ic ate s a me d ic a l 2 60 8

5.2 .7 N o n- s ter i le I nd ic ate s a me d ic a l T h i s s y m b o l s h o u ld o n l y 2 60 9

s ter i l i z ati o n p ro ce s s . s i m i l a r me d ic a l de vice s

5.2 .8 D o no t u s e i f p acka ge I nd ic ate s a me d ic a l NOTE T h i s s ym b o l m ay a l s o m e a n I n E u ro p e , b th i s s y m b o l 2606

i s d a m a ge d de vice th at s ho u ld no t “D o no t u s e i f the p ro duc t s ter i le s h a l l b e e x pl a i ne d i n the

h a s b e en d a m a ge d o r co mp ro m i s e d”. the m a nu fac tu rer.