ISO
15223-1
INTERNATIONAL
STANDARD
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 —
General requirements
Part 1:
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)
--,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 ISO 15223-1:2016(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reprodu i ct i ion or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved ---`,,`,`,,`,,`-`-`,```,,,,,`,`,`,,,,,`,,,,--
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 Proposal of symbols for adoption ...........................................................................................................................................2
4.2 Requirements for usage ..................................................................................................................................................................2
5 Symbols 3
4.3 Other symbols ..........................................................................................................................................................................................3
Annex A Examples 20
..........................................................................................................................................................................................................................
Annex B Use of general prohibition symbol and negation symbol 24
(informative) ...........................................................................................................................................................................
Bibliography 25
(informative) ...............................................
.............................................................................................................................................................................................................................
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--,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- ISO 15223-1:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of 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 of 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 different types of ISO documents should be noted. This document was drafted 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 of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of 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 information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.isQou.oarligt/yi smo/afnoargeewmoerndt.h atmndl .corresponding general aspects for medical devices The committee responsible for this document is ISO/TC 210, . This third edition cancels and replaces the second edition (ISO 15223-1:2012), which has been technically revised with the following principal revisions: — Clause 2, updated the title of ISO 7000 and added the “date of release” for each of the registered symbols to Table 1; — symbol 5.1.1, modified the requirement related to the placement of the manufacturer’s name and address on IVD labels; — symbol 5.1.2, modified the requirement related to the placement of name and address of the authorized representative in the European Union on IVD labels; — symbol 5.4.3, added the information used to indicate an instruction to consult an electronic instructions for use (eIFU); — symbol 5.4.5, added the reference to ISO 7000, symbol 2725, “Contains or presence of”; — symbol 5.5.5, modified the description of the symbol and the requirement regarding use with IVD; — A.15, added the examples of the placement of the eIFU indicator. A list of all parts in the ISO 15223 series can be found on the ISO website. NOTE Future symbols intended to appear in this document are to be validated in accordance with ISO 15223-2. This corrected version of ISO 15223-1:2016 incorporates the following correction: — in A.9, the graphical symbol of NOTE 2 has been corrected. --,,,,,,,,,,,,,,,,,`-`-`,,`,,`,`,,`--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reprodu i ct v ion or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved ISO 15223-1:2016(E) Introduction This document addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the medical device in most regulatory domains. The information 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 information with medical devices. At the same time, manufacturers seek to take costs out of 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 of different languages can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of 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 of symbols proposed for adoption. This is the subject of ISO 15223-2. This document is primarily intended to be used by manufacturers of 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. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT v --``,,,,`,,,,,`,`,`,,,,,,--,,,,,,,--- --``,,,,,,,,,,,,,,,,```,--,,,,,,,---
Copyright International Organization for Standardization
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INTERNATIONAL STANDARD ISO 15223-1:2016(E)
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied —
General requirements
Part 1:
1 Scope
This document identifies requirements for symbols used in medical device labelling that convey
information on the safe and effective use of medical devices. It also lists symbols that satisfy the
requirements of this document.
This document is applicable to symbols used in a broad spectrum of medical devices, which are
marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated
documentation. The requirements of this document are not intended to apply to symbols specified in
other standards.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated refGerreanpcheicsa, lt hsyem labtoelsst feodr iutisoen o onf e tqhuei prmefeenret n—ce Rde dgoisctuemreedn sty (minbcolulsding any amendments) applies.
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ISO 15223-1:2016(E)
3.2
description
normative text which defines the purpose, application and use of the symbol
[3S.O3URCE: IEC 80416-1:2008, 3.2]
label
written, printed or graphic information provided upon the medical device itself
[3S.4OURCE: GHTF/SG1/N43:2005]
labelling
information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical
device or any of its containers or wrappers description
Note 1 to entry: This information relates to the identification, technical (3.2) and use of the medical
device, but excludes shipping documents.
Note 2 to entry: Some regional and national regulations refer to “labelling” as “information supplied by the
m3.a5nufacturer”.
symbol used in medical device labelling
label
characteristic information
graphical representation appearing on the (3.3) and/or associated documentation of a medical
device that communicates (3.1) without the need for the supplier or receiver
of the information to have knowledge of the language of a particular nation or people
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar
o3b.6jects, including alphanumeric characters.
title
unique name by which a graphical symbol is identified and spoken of
[SOURCE: IEC 80416-1:2008, 3.9]
4 General requirementsSymbols 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 of medical devices and have global or regional applicability.
When risk management shows it to be appropriate for symbols to be used to convey information
essential for proper use on the medical device, its packaging or in associated documentation, the
symbols given in Table 1 may be used.
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--`,,,,,,,,,,,,,,,,```,--,,,,,,,---
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 of filled or shaded areas.
NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which
contains the complete set of 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 different formats (e.g. AI, DWG,
EPS) and some additional data as applicable is provided. Various search and navigation facilities allow for easy
retrieval of graphical symbols.
As part of risk management, the manufacturer should determine the appropriate size for the symbol to
be legible for its intended function.
NOTE 2 This document does not specify colours or minimum size for the symbols in Table 1, nor does it specify
the relative size of symbols and that of indicated information.
It is important that symbols be used properly. Guidance on appropriate use of the general prohibition
symbol and the negation symbol is given in Annex B.
Before symbols are used, the manufacturer shall carry out a risk assessment that indicates that the use
of 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 of the symbol given in this document should be considered sufficient. All dates and times presented
in association with symbols shall use the conventions set out in ISO 8601.
Other standards specify additional symbols that are applicable to particular kinds or groups of
medical devices or to particular situations. Examples of 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 manufacturer may use any appropriate symbol regardless of category.
NOTE Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is
grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the
categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.
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ISO 15223-1:2016(E)
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---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 6.1.5 b 3942 eht ,eporuE nI eht fo ezis evitaler ehT ETON s’rerutcafunam ehT eht setacidnI rebmun eugolataC s’rerutcafunam eugolatac eht fo ezis eht dna lobmys eb llahs rebmun eugolatac s’rerutcafunam 51-10-4002 llahs rebmun eugolatac .deificeps ton era rebmun .lobmys eht ot tnecajda os rebmun eugolatac woleb ro retfa decalp eb ecived lacidem eht taht tnecajda dna lobmys eht rof smynonyS ETON .deifitnedi eb nac yam lobmys sihT .ti ot era ”rebmun eugolatac“ nwohs eb yltnerruc dna ”rebmun ecnerefer“ ;erusolcne eht tuohtiw .”rebmun redroer“ dednetni si ti ,revewoh eb noitpo siht taht erutuf a ni nwardhtiw .tnemucod siht fo noitide 7.1.5 b 8942 eht ,eporuE nI eht fo ezis evitaler ehT ETON eb llahs lobmys sihT eht setacidnI rebmun laireS laires s’rerutcafunam laires eht fo ezis eht dna lobmys eht yb deinapmocca laires s’rerutcafunam 51-10-4002 decalp eb llahs rebmun .deificeps ton era rebmun laires s’rerutcafunam cificeps a taht os rebmun eht woleb ro retfa rebmun laires ehT .rebmun eb nac ecived lacidem ot tnecajda dna lobmys eht ot tnecajda eb llahs .deifitnedi -ruc yam lobmys sihT .ti .lobmys tuohtiw nwohs eb yltner ,revewoh ;erusolcne eht siht taht dednetni si ti ni nwardhtiw eb noitpo siht fo noitide erutuf a .tnemucod 8 --``,,,,,,,,,,,,,,,,```,--,,,,,,,---
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ISO 15223-1:2016(E)
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2 ETON
citpesa
detpecca
.1.2.5
lobmys
fo esu
eht
sedulcerp
.seuqinhcet
3.2.5
b
1052
lobmys
siht
,eporuE
nI
-erp
lobmys
siht
fo
esU
ETON
lacidem
a
setacidnI
gnisu
deziliretS
no
esu ot
detcirtser
si
.1.2.5
lobmys
fo
esu
eht
sedulc
neeb
sah
taht
ecived
edixo
enelyhte
51-10-4002
dezilirets
yllanimret
enelyhte
gnisu
dezilirets
secived
lacidem
.edixo
1.4
,1002:1-655
NE(
sti
gnidulcni
,seilppa
.)eton
detaicossa
4.2.5
b
2052
lobmys
siht
,eporuE
nI
eb
nac
lobmys
sihT
1 ETON
lacidem
a
setacidnI
gnisu
deziliretS
no
esu ot
detcirtser
si
tcudorp
eht
taht etacidni
ot
desu
neeb
sah
taht
ecived
noitaidarri
51-10-4002
dezilirets
yllanimret
noitaidarri
ot detcejbus
neeb
sah
gnisu
dezilirets
secived
lacidem
.sessecorp
.noitaidarri
1.4
,1002:1-655
NE(
sti
gnidulcni
,seilppa
lobmys
siht fo
esU
2 ETON
.)eton
detaicossa
.1.2.5
lobmys
fo esu
eht
sedulcerp
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT
---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 5.2.5 b 3052 lobmys siht ,eporuE nI lobmys siht fo esU ETON lacidem a setacidnI maets gnisu deziliretS no esu ot detcirtser si .1.2.5 lobmys fo esu eht sedulcerp neeb sah taht ecived taeh yrd ro 51-10-4002 dezilirets yllanimret ro maets gnisu dezilirets secived lacidem .taeh yrd 1.4 ,1002:1-655 NE( sti gnidulcni ,seilppa .)eton detaicossa 6.2.5 8062 lacidem a setacidnI eziliretser ton oD eb ot ton si taht ecived 51-10-4002 .deziliretser 7.2.5 9062 ylno dluohs lobmys sihT lacidem a setacidnI elirets-noN hsiugnitsid ot desu eb neeb ton sah taht ecived 51-10-4002 ro lacitnedi neewteb a ot detcejbus secived lacidem ralimis .ssecorp noitazilirets dna elirets htob ni dlos .snoitidnoc elirets-non 8.2.5 b 6062 lobmys siht ,eporuE nI naem osla yam lobmys sihT ETON lacidem a setacidnI egakcap fi esu ton oD eht ni denialpxe eb llahs elirets tcudorp eht fi esu ton oD“ ton dluohs taht ecived degamad si 51-10-4002 yb deilppus noitamrofni si gnigakcap sti ro metsys reirrab egakcap eht fi desu eb .rerutcafunam eht .”desimorpmoc ro degamad neeb sah .denepo Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved --``,,,,,,,,,,,,,,,,```,--,,,,,,,---
ISO 15223-1:2016(E)
)deunitnoc(
elbaT
ecnerefeR
0007
OSI
lanoitiddA
fo
snoitcirtseR
evitamrofnI
fo noitpircseD
stnemeriuqeR
lobmys
fo
eltiT
fo
rebmun
.on
.geR
stnemeriuqer
esu
seton
lobmys
lobmys
a
9.2.5
b
4803
lobmys
siht
,eporuE
nI
noitazilirets
fo dohtem
ehT
fo ecneserp
eht
setacidnI
htap
diulf
eliretS
eht
ni
denialpxe
eb
llahs
eht
ni
detacidni
eb
llahs
-htiw htap
diulf
elirets
a
50-01-1102
yb
deilppus
noitamrofni
.etairporppa
sa
,xob
ytpme
ni ecived
lacidem
eht
ni
.rerutcafunam
eht
strap rehto
nehw
sesac
lacidem
eht
fo
trap
ehT
,ecived
lacidem
eht
fo
llahs
elirets
si
taht
ecived
,roiretxe
eht
gnidulcni
eht
ni deifitnedi
eb
deilppus
eb
ton
thgim
yb
deilppus
noitamrofni
.elirets
.rerutcafunam
eht
egarotS
3.5
1.3.5
1260
lacidem
a setacidnI
htiw
eldnah
,eligarF
eb nac
taht
ecived
erac
40-60-4102
ton fi degamad
ro
nekorb
.ylluferac
deldnah
2.3.5
4260
naem
osla
nac
lobmys
sihT
ETON
lacidem
a setacidnI
morf
yawa
peeK
sa
,”taeh
morf
yawa
peeK“
sdeen
taht
ecived
thgilnus
40-60-4102
.0007
OSI
ni
decnerefer
thgil morf
noitcetorp
.secruos
3.3.5
b
5160
lobmys
siht
,eporuE
nI
naem
osla
nac
lobmys
sihT
ETON
lacidem
a setacidnI
dna
taeh
morf
tcetorP
eht
ni
denialpxe
eb
llahs
dna
thgilnus
morf
yawa
peeK“
sdeen
taht
ecived
secruos
evitcaoidar
51-10-4002
yb
deilppus
noitamrofni
.”secruos
evitcaoidar
dna taeh morf
noitcetorp
.rerutcafunam
eht
.secruos
evitcaoidar
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT
---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 4.3.5 6260 naem osla nac lobmys sihT ETON lacidem a setacidnI yrd peeK sa ”niar morf yawa peeK“ ot sdeen taht ecived 40-60-4102 .0007 OSI ni decnerefer morf detcetorp eb .erutsiom 5.3.5 4350 -repmet fo timil rewol ehT timil rewol eht setacidnI -repmet fo timil rewoL detacidni eb llahs eruta hcihw ot erutarepmet fo eruta 51-10-4002 rewol eht ot tnecajda nac ecived lacidem eht .enil latnoziroh .desopxe ylefas eb 6.3.5 3350 -repmet fo timil reppu ehT timil reppu eht setacidnI fo timil reppU detacidni eb llahs eruta hcihw ot erutarepmet fo erutarepmet 51-10-4002 reppu eht ot tnecajda nac ecived lacidem eht .enil latnoziroh .desopxe ylefas eb 7.3.5 2360 stimil rewol dna reppu ehT eht setacidnI timil erutarepmeT eb llahs erutarepmet fo stimil erutarepmet 40-60-4102 eht ot tnecajda detacidni lacidem eht hcihw ot latnoziroh rewol dna reppu ylefas eb nac ecived .senil .desopxe 12 --``,,,,,,,,,,,,,,,,```,--,,,,,,,---
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved
ISO 15223-1:2016(E)
)deunitnoc(
elbaT
ecnerefeR
0007
OSI
lanoitiddA
fo
snoitcirtseR
evitamrofnI
fo noitpircseD
stnemeriuqeR
lobmys
fo
eltiT
fo
rebmun
.on
.geR
stnemeriuqer
esu
seton
lobmys
lobmys
a
8.3.5
b
0262
lobmys
siht
,eporuE
nI
ytidimuh
ehT
fo egnar
eht
setacidnI
ytidimuH
eht
ni
denialpxe
eb
llahs
eb
llahs
noitatimil
eht hcihw
ot
ytidimuh
noitatimil
51-10-4002
yb
deilppus
noitamrofni
eht
ot tnecajda
detacidni
eb nac
ecived
lacidem
.rerutcafunam
eht
latnoziroh
rewol
dna
reppu
.desopxe
ylefas
.senil
9.3.5
b
1262
lobmys
siht
,eporuE
nI
erusserp
cirehpsomta
ehT
fo egnar
eht
setacidnI
cirehpsomtA
eht
ni
denialpxe
eb
llahs
eb
llahs
snoitatimil
erusserp
cirehpsomta
erusserp
51-10-4002
yb
deilppus
noitamrofni
eht
ot tnecajda
detacidni
lacidem
eht
hcihw
ot
noitatimil
.rerutcafunam
eht
latnoziroh
rewol
dna
reppu
ylefas
eb nac
ecived
.senil
.desopxe
esu
efaS
4.5
1.4.5
9560
.0107
OSI
eeS
si lobmys
sihT
ETON
ereht
taht
setacidnI
sksir
lacigoloiB
htiw
desufnoc
eb
ot
ton
lacigoloib
laitnetop
era
51-10-4002
ngis
”drazahoiB“
eht
eht htiw
detaicossa
sksir
eht
ni desu
eb
ot dednetni
.ecived
lacidem
.ecalpkrow
2.4.5
1501
-er
ton
oD“
rof
smynonyS
ETON
lacidem
a
setacidnI
esu-er
ton
oD
ylno
esu“
dna
”esu
elgnis“
era
”esu
dednetni
si taht
ecived
51-10-4002
.”ecno
no esu rof
ro ,esu
eno
rof
a gnirud
tneitap
elgnis
a
.erudecorp
elgnis
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT
---,,,,,,,--,```,,,,,,,,,,,,`,,,,``--
ISO 15223-1:2016(E)
)deunitnoc(
elbaT
ecnerefeR
0007
OSI
lanoitiddA
fo
snoitcirtseR
evitamrofnI
fo
noitpircseD
stnemeriuqeR
lobmys
fo
eltiT
fo
rebmun
.on
.geR
stnemeriuqer
esu
seton
lobmys
lobmys
a
3.4.5
1461
etacidni
ot desu
nehW
tlusnoC“
rof mynonyS
ETON
rof
deen eht
setacidnI
snoitcurtsni
tlusnoC
tlusnoc
ot
noitcurtsni
na
tlusnoC“
si ”esu
rof
snoitcurtsni
eht
tlusnoc
ot
resu
eht
esu
rof
51-10-4002
-curtsni
cinortcele
na
.”snoitcurtsni
gnitarepo
.esu
rof snoitcurtsni
siht ,)UFIe(
esu
rof snoit
deinapmocca
si
lobmys
ecnereffid
eht redisnoC
ETON
.rotacidni
UFIe
na
yb
siht
fo
noitpircsed
eht neewteb
yam
rotacidni
sihT
.4.4.5
lobmys
fo
taht
dna lobmys
-cafunam
eht tneserper
ro etisbew
UFIe
s’rerut
etairporppa
rehto
yna
esu
eht
no noitacidni
rotacidni
ehT
.UFIe
fo
rehtie
decalp
eb yam
ro
htaeneb
,edisgnola
lobmys
eht
gnidnuorrus .)51.A
ees(
eb
ot
ton
si
lobmys
sihT
ecnereffid
eht redisnoC
ETON
tnairav
lobmys
ehT
rof
deen eht
setacidnI
noituaC
eht
htiw
desufnoc
siht
fo
noitpircsed
eht neewteb
B4340
lobmys
,0007
OSI
eht
tlusnoc
ot
resu
eht
51-10-4002
dednetni
ngis
”noituaC“
.3.4.5
lobmys
fo
taht
dna lobmys
.desu
eb
yam
)”noituaC“(
rof esu
rof snoitcurtsni
eht
ni
desu
eb
ot
yranoituac
tnatropmi
.ecalpkrow
yllaitnesse
si
lobmys
sihT
ETON
sa
hcus noitamrofni
desu
si
dna
lobmys
yranoituac
a
dna
sgninraw
era ereht
taht
tcaf
eht
thgilhgih
ot
,tonnac
taht snoituacerp
snoituacerp
ro sgninraw
cificeps
,snosaer
fo yteirav
a
rof
,ecived
lacidem
eht
htiw
detaicossa
eht
no detneserp
eb
no dnuof
esiwrehto
ton
era
hcihw
.flesti
ecived
lacidem
.lebal
eht
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved
---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 5.4.5 b fo noitacilppA lobmys siht ,eporuE nI dluohs lobmys sihT dednetni si lobmys sihT ETON ecneserp eht setacidnI ecneserp ro sniatnoC lobmys ,0007 OSI eht ni denialpxe eb llahs lacidem rof desu eb ton yam ohw elpoep esoht nraw ot yrd ro rebbur larutan fo xetal rebbur larutan fo 5272 yb deilppus noitamrofni gniniatnoc secived niatrec ot snoitcaer cigrella evah a sa xetal rebbur larutan .rerutcafunam eht .”rebbur citehtnys“ .xetal ni snietorp -curtsnoc fo lairetam 80-90-5002 lacidem eht nihtiw noit gnigakcap eht ro ecived .ecived lacidem a fo cificeps-DVI 5.5 ortiv nI 1.5.5 ni ni b A/N lobmys siht ,eporuoEr tnivI ylno dluohs lobmys osrihtiTv orti vl anciidem a setacidnI citsongaid yfitnedi ot desu ylno si yfitnedi ot desu eb dednetni si taht ecived ecived lacidem lacidem citsongaid lacidem citsongaid na sa desu eb ot UE ni denifed sa secived or toivt tnoin dna secived lacidem citsongaid .CE/97/89 evitceriD lacidem eht taht yficeps .ecived “ rof si ecived .”esu 2.5.5 A/N esu ,slortnoc evitagen roF ETON lortnoc a setacidnI lortnoC evitisop rof dna 3.5.5 lobmys dednetni si taht lairetam 4942-0007 OSI ETON .4.5.5 lobmys esu ,slortnoc -rofrep eht yfirev ot yb nwardhtiw saw fo scitsiretcarahc ecnam .3 CS/541 CT/OSI .ecived lacidem rehtona sdrow dna sretteL sa deretsiger ton era ni slobmys lacihparg .0007 OSI 3.5.5 5942 lortnoc a setacidnI lortnoc evitageN dednetni si taht lairetam 51-10-4002 ni stluser eht yfirev ot evitagen detcepxe eht .egnar --``,,,,,,,,,,,,,,,,```,--,,,,,,,---
Copyright International Organization for Standardization
Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly
No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT
ISO 15223-1:2016(E)
)deunitnoc(
elbaT
ecnerefeR
0007
OSI
lanoitiddA
fo
snoitcirtseR
evitamrofnI
fo
noitpircseD
stnemeriuqeR
lobmys
fo
eltiT
fo
rebmun
.on
.geR
stnemeriuqer
esu
seton
lobmys
lobmys
a
4.5.5
6942
lortnoc
a
setacidnI
lortnoc
evitisoP
dednetni
si
taht
lairetam
51-10-4002
ni
stluser
eht
yfirev
ot
evitisop
detcepxe
eht
.egnar
5.5.5
n
fo
noitacilppA
eht
fo
ezis
evitaler
ehT
ETON
taht
stset
fo
rebmun
ehT
latot
eht
setacidnI
rof
tneiciffus
sniatnoC
lobmys
,0007
OSI
stset
fo
rebmun
eht
dna
lobmys
eht
htiw
demrofrep
eb
nac
taht
stset
DVI
fo
rebmun
stset
< 8150 .yrav nac demrofrep tnecajda raeppa llahs DVI htiw demrofrep eb nac .lobmys eht ot .DVI eht 51-10-4002 Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved ---
< > Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved --``,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- 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 Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT ISO 15223-1:2016(E) Annex B Use of general prohib(itiniofonr smyamtibveo)l 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 labelling, the prohibition circle with a diagonal bar should be used to mean “do not”, e.g. symbol 5.4.2 “Do not re-use”. It is sometimes used out of context in medical device labelling, e.g. to mean “does not contain”. It is important that usage be consistent with the intended meaning so that hazards do not arise from misunderstanding. B.2 Negation symbol Manufacturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing this meaning does not exist, should follow the method set out in IEC 80416-3:2002, Clause 7 (a large “X” placed over the symbol). Although it is not generally recommended that this symbology be used with any of the symbols given in this document, the use of the negation symbol is permitted. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved --``,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- ISO 15223-1:2016(E) Bibliography Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings [1] ISO 3864-1, Graphical symbols — Safety colours and safety signs — Registered safety signs [2] ISO 7010, Medical devices — Application of risk management to medical devices [3] ISO 14971, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements [4] ISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use 2) [5] ISO 18113-2 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use 3) [6] ISO 18113-3 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing 4) [7] ISO 18113-4 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing 5) [8] ISO 18113-5 , Graphical symbols for use on equipment [9] IEC 60417, Basic principles for graphical symbols for use on equipment — Part 1: Creation of graphical symbols for registration [10] IEC 80416-1, Basic principles for graphical symbols for use on equipment — Part 3: Guidelines for the application of graphical symbols [11] IEC 80416-3:2002, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices [12] EN 556-1:2001, Information supplied by the manufacturer of medical devices [13] EN 1041, [14] GHTF/SG1/N43. 2005, Labelling for medical devices. Available at: http://www.imdrf.org/docs/ ghtf/final/sg1/technical-docs/ghtf-sg1-n43-2005-labelling-medical-devices-050603.pdf 2) Cancels and replaces EN 375:2001. 3) Cancels and replaces EN 591:2001. 4) Cancels and replaces EN 376:2002. 5) Cancels and replaces EN 592:2002. 25 Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT --``,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- ISO 15223-1:2016(E) ICS 01.080.20; 11.040.01 Price based on 25 pages --``,,,,`,,,,,`,`,`,,,,,```,`-`-`,,`,,`,`,,`--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reprodu©ctio nI oSr One t2wo0rk1ing6 p e–rm Aittelld wriithgohutt lisce rnsees freomr vIHeSd Not for Resale, 10/14/2019 19:24:48 MDT,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 6.5.5 fo noitacilppA ton llahs lobmys sihT rof DVI“ si mynonys A 1 ETON ecived DVI na setacidnI ecnamrofrep DVI roF lobmys ,0007 OSI eht no yltnioj raeppa .”ylno esu lanoitagitsevni eb ot dednetni si taht ylno noitaulave 3803 gnillebal eht ni ro lebal gnitaulave rof ylno desu gniraeb ecived DVI na fo si taht ecived lacidem A 2 ETON ecnamrofrep sti 30-01-1102 lobmys eht noitaulave ecnamrofreoprt DivV nIi rof ti erofeb scitsiretcarahc rof desu eb ot dednetni ton si ylno tekram eht no decalp si noitanimaxe citsongaid na citsongaid lacidem rof dleiy ot .e.i( sesoprup lacidem rof .esu .)stluser citsongaid eht taht snaem hcihw ni na si ecived lacidem lacidem citsongaid ortiv eht yb dednetni ecived desu eb ot rerutcafunam citsongaid ortiv ni na rof .noitanimaxe noisufni/noisufsnarT 6.5 1.6.5 b 5172 lobmys siht ,eporuE nI detaicossa eb ot ton si sihT ETON lacidem a setacidnI etis gnilpmaS eht ni denialpxe eb llahs erehw tneitap a no etis a htiw doolb ro ecived 80-90-5002 yb deilppus noitamrofni .nekat era selpmas noitacilppa gnissecorp .rerutcafunam eht metsys a sedulcni taht -celloc eht ot detacided nevig a fo selpmas fo noit eht ni derots ecnatsbus doolb ro ecived lacidem .reniatnoc --``,,,,,,,,,,,,,,,,```,--,,,,,,,--- Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 2.6.5 b 2272 lobmys siht ,eporuE nI fo ecneserp eht setacidnI htap diulF eht ni denialpxe eb llahs .htap diulf a 80-90-5002 yb deilppus noitamrofni .rerutcafunam eht 3.6.5 b 4272 lobmys siht ,eporuE nI lacidem a setacidnI cinegoryp-noN eht ni denialpxe eb llahs si taht ecived 80-90-5002 yb deilppus noitamrofni .cinegoryp-non .rerutcafunam eht 4.6.5 b 6272 lobmys siht ,eporuE nI rep spord fo rebmun ehT ETON fo rebmun eht setacidnI ertilillim rep sporD eht ni denialpxe eb llahs nwohs si ;deificeps si ertilillim .ertilillim rep spord 80-90-5002 yb deilppus noitamrofni decalper eb lliw dna elpmaxe na sa .rerutcafunam eht spord fo rebmun etairporppa eht yb .ertilillim rep 5.6.5 b 7272 lobmys siht ,eporuE nI eht fo ezis erop lanimon ehT ETON noisufni na setacidnI erop htiw retlif diuqiL eht ni denialpxe eb llahs na sa nwohs si 51 ;deificeps si retlif metsys noisufsnart ro ezis 80-90-5002 yb deilppus noitamrofni eht yb decalper eb lliw dna elpmaxe ecived lacidem eht fo .rerutcafunam eht .ezis erop etairporppa fo retlif a sniatnoc taht lanimon ralucitrap a .ezis erop Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved ---,,,,,,,--,```,,,,,,,,,,,,,,,,``-- ISO 15223-1:2016(E) )deunitnoc( elbaT ecnerefeR 0007 OSI lanoitiddA fo snoitcirtseR evitamrofnI fo noitpircseD stnemeriuqeR lobmys fo eltiT fo rebmun .on .geR stnemeriuqer esu seton lobmys lobmys a 6.6.5 b 8272 lobmys siht ,eporuE nI resu eht rof tnatropmi si tI ETON lacidem a setacidnI evlav yaw-enO eht ni denialpxe eb llahs ylno si wolf eht taht wonk ot taht evlav a htiw ecived 80-90-5002 yb deilppus noitamrofni tonnac dna noitcerid eno ni elbissop eno ylno ni wolf swolla .rerutcafunam eht .desrever eb .noitcerid srehtO 7.5 1.7.5 b 0162 lobmys siht ,eporuE nI euqinu a setacidnI rebmun tneitaP eht ni denialpxe eb llahs htiw detaicossa rebmun 51-10-4002 yb deilppus noitamrofni .tneitap laudividni na .rerutcafunam eht a .rebmuN noitartsigeR eht woleb nwohs si etad sihT .”etad noitartsiger“ a sah )iu/pbo/gro.osi.www//:sptth ta elbaliava( esabatad slobmys CEI/OSI eht ni lobmys hcaE b .noitcirtser ro tnemeriuqer siht evah sevitceriD UE eht ni nwod dial selpicnirp eht gniylppa seirtnuoc ylno ,tnemom eht tA Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT ---,,,,,,,--,,,,,,`,`,`,,,,,`,,,,``-- ISO 15223-1:2016(E) Annex A (iEnfxoarmmpalteivse) 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 Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or networking permitted without license from IHS Not for Resale, 10/14/2019 19:24:48 MDT © ISO 2016 – All rights reserved --``,,,,`,,,,,`,`,`,,,,,,--,,,,,,,--- 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 Examples of use of symbols for “Sterile fluid path” NOTE 1 Medical device contains a sterile fluid path that has been sterilized using ethylene oxide. Copyright International Organization for Standardization Provided by IHS Markit under license with ANSI Licensee=Becton Dickinson - Loc 1 - 61, 64/5984713001, User=Chiu, Shelly No reproduction or network©ing pIeSrmOit te2d0 w1ith6ou t– lic Aenlsle rfroimg hIHtSs reserved Not for Resale, 10/14/2019 19:24:48 MDT ---,,,,,,,--,`,,,,,`,`,`,,,,,`,,,,-- ISO 15223-1:2016(E) NOTE 2 Medical device contains a sterile fluid path that has been sterilized using irradiation. NOTE 3 Medical device contains a sterile fluid path that has been sterilized using steam or dry heat. 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 of use of symbol 5.5.5, “Contains sufficient for n tests”
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