SIST EN ISO 15223-1:2017
(Main)Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
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.
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole, Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO 15223-1:2016)
Dieser Teil der ISO 15223 legt Anforderungen an Symbole zur Verwendung in Kennzeichnungen von Medizinprodukten fest, die zur Lieferung von Informationen für die sichere und wirkungsvolle Anwendung von Medizinprodukten angewendet werden. Sie führt auch eine Liste von Symbolen auf, die den Anforderungen dieses Teils der ISO 15223 entsprechen.
Dieser Teil der ISO 15223 gilt für Symbole, die auf ein breites Spektrum von Medizinprodukten anwendbar sind, die weltweit in Verkehr gebracht werden und daher unterschiedliche behördliche Anforderungen erfüllen müssen.
Diese Symbole dürfen auf dem Medizinprodukt selbst, auf seiner Verpackung oder in den zugehörigen Dokumenten verwendet werden. Die Anforderungen dieses Teils der ISO 15223 sind nicht dazu vorgesehen, für Symbole zu gelten, die in anderen Normen festgelegt sind.
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales (ISO 15223-1:2016)
ISO 15223-1:2016 identifie les exigences s'appliquant aux symboles utilisés dans l'étiquetage des dispositifs médicaux et fournissant des informations en vue d'une utilisation correcte et sûre de ces dispositifs. Il répertorie également les symboles satisfaisant à ses exigences.
ISO 15223-1:2016 s'applique aux symboles utilisés pour une vaste gamme de dispositifs médicaux commercialisés au niveau mondial et devant à ce titre répondre à diverses exigences réglementaires.
Ces symboles peuvent figurer sur le dispositif médical lui-même, sur son emballage ou dans la documentation associée. Les exigences du présent document n'ont pas pour objectif d'être appliquées aux symboles spécifiés dans d'autres normes.
Medicinski pripomočki - Simboli za označevanje medicinskih pripomočkov, označevanje in podatki, ki jih mora podati dobavitelj - 1. del: Splošne zahteve (ISO 15223-1:2016)
Ta dokument opredeljuje zahteve glede simbolov za označevanje medicinskih pripomočkov, ki podajajo informacije o varni in učinkoviti uporabi medicinskih pripomočkov. Navaja tudi simbole, ki ustrezajo zahtevam iz tega dokumenta.
Ta dokument se uporablja za simbole, ki se uporabljajo pri različnih medicinskih pripomočkih na globalnem tržišču in morajo zato izpolnjevati različne predpisane zahteve.
Ti simboli se uporabljajo na samih medicinskih pripomočkih, na njihovi embalaži ali v priloženi dokumentaciji. Zahteve tega dokumenta se ne uporabljajo za simbole, ki so določeni v drugih standardih.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15223-1:2017
01-februar-2017
1DGRPHãþD
SIST EN ISO 15223-1:2012
0HGLFLQVNLSULSRPRþNL6LPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
R]QDþHYDQMHLQSRGDWNLNLMLKPRUDSRGDWLGREDYLWHOMGHO 6SORãQH]DKWHYH ,62
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO 15223-1:2016)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen (ISO
15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO 15223-1:2016)
Ta slovenski standard je istoveten z: EN ISO 15223-1:2016
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 15223-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15223-1:2017
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SIST EN ISO 15223-1:2017
EUROPEAN STANDARD
EN ISO 15223-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2016
ICS 01.080.20; 11.040.01
Supersedes EN ISO 15223-1:2012
English version
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements (ISO 15223-1:2016)
Dispositifs médicaux - Symboles à utiliser avec les Medizinprodukte - Bei Aufschriften von
étiquettes, l'étiquetage et les informations à fournir Medizinprodukten zu verwendende Symbole,
relatifs aux dispositifs médicaux - Partie 1: Exigences Kennzeichnung und zu liefernde Informationen - Teil
générales (ISO 15223-1:2016) 1: Allgemeine Anforderungen (ISO 15223-1:2016)
This European Standard was approved by CEN on 22 October 2016.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal 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 CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2016 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 15223-1:2016 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on Medical Devices . 5
Annex ZB (informative) Relationship between this European standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 8
Annex ZC (informative) Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
European foreword
This document (EN ISO 15223-1:2016) has been prepared by Technical Committee ISO/TC 210 “Quality
management and corresponding general aspects for medical devices” in collaboration with Technical
Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be
withdrawn at the latest by May 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 15223-1:2012.
This document 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).
For relationship with EU Directive(s), see informative Annex ZA, Annex ZB and Annex ZC, which are
integral parts of this document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA/Annex ZB/Annex ZC”, the user should always check that any referenced
document has not been superseded and that its relevant contents can still be considered the generally
acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlations between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
a
ISO 7000 — ISO 7000:2014
ISO 8601 — ISO 8601:2004
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 15223-2 — ISO 15223-2:2010
a
Available only in database format from ISO or IEC.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15223-1:2016 has been approved by CEN as EN ISO 15223-1:2016 without any
modification.
4
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on Medical Devices
This European Standard has been prepared under a Commission's standardization request 'M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”,
“minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements (ERs) Clause(s)/subclause(s) of this Qualifying remarks/Notes
of Directive 93/42/EEC European Standard
8.7 5.2.7 Provided that the symbol is
provided according to the
general requirements indicated
in the ER 13.1 of Directive
93/42/EEC and only for non-
sterile products.
13.2 4.2, 4.3 Only the first sentence of this
ERs is covered, provided that the
symbol is provided on the label
and according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
5
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
13.3 (a) 5.1.1, 5.1.2 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (c) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, Provided that the symbol is
5.2.9 provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (d) 5.1.5, 5.1.7 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC. If a
Serial number is not provided
the symbol for 'LOT' must
precede the batch code.
13.3 (e) 5.1.4 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
“use-by” date must be expressed
as, at least, the year and the
month.
13.3 (f) 5.4.2 Only the first sentence of this ER
is covered, provided that the
symbol is provided on the label
and according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
13.3 (i) 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, Provided that the symbol is
5.3.6, 5.3.7, 5.3.8, 5.3.9 provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
ER is only covered with respect
to the conditions indicated by
the symbols. For other
conditions, other symbols or
other means of indication may
be needed.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
13.3 (k) 5.2.6, 5.2.7, 5.2.8, 5.4.1, 5.4.4, Provided that the symbol is
5.4.5 provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
ER is only covered with respect
to the warnings indicated by the
symbols. For other warnings,
other symbols or other means of
indication may be needed.
13.3 (l) 5.1.3 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC.
Active medical devices must be
labelled with at least the year of
manufacture unless a “use-by”
date (5.1.4) is given. The date of
manufacture may be included in
the batch or serial number
(5.1.5, 5.1.7).
13.3 (m) 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
provided on the label and
according to the general
requirements indicated in the ER
13.1 of Directive 93/42/EEC, the
ER is only covered with respect
to the conditions indicated by
the symbols.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
Annex ZB
(informative)
Relationship between this European standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request 'M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive of 20 June 1990 on the
approximation of the laws of the Member States relating to active implantable medical devices [OJ L
189].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 90/385/EEC as amended by 2007/47/EC. This
means that risks have to be reduced “as far as possible”, “to a minimum”, “to the lowest possible level”,
“minimized” or “removed”, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 4, 5, 8, 9 and 10 of the Directive.
NOTE 3 This Annex ZB is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this
European Standard.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on
active implantable medical devices
Essential Requirements (ERs) Clause(s)/subclause(s) of this Qualifying remarks/Notes
of Directive 90/385/EEC European Standard
11 5.1.5, 5.1.6, 5.1.7 ER is covered only for indication
of batch code or serial number.
Components are not covered”.
14.1, 1st indent 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
provided on the sterile pack,
This ER is only covered with
respect to the conditions
indicated by the symbols. For
other warnings, other symbols
or other means of indication
may be needed.
14.1, 2nd indent 5.2.1, 5.2.2, 5.2.3, 5.2.4. 5.2.5 Provided that the symbol is
provided on the sterile pack.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
14.1, 3rd indent 5.1.1 Provided that the symbol is
provided on the sterile pack.
14.1, 7th indent 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5 Provided that the symbol is
provided on the sterile pack.
14.1, 8th indent 5.1.3 Provided that the symbol is
provided on the sterile pack.
Active implantable medical
devices must be labelled with at
least the month and year of
manufacture.
14.1, 9th indent 5.1.4 Provided that the symbol is
provided on the sterile pack.
14.2, 1st indent 5.1.1, 5.1.2 Provided that the symbol is
provided on the sales packaging.
The 'Trade name' of the
manufacturer must not be used
with this symbol.
14.2, 7th indent 5.2.1 Provided that the symbol is
provided on the sales packaging.
14.2, 8th indent 5.1.3 Provided that the symbol is
provided on the sales packaging.
14.2, 9th indent 5.1.4 Provided that the symbol is
provided on the sales packaging.
14.2, 10th indent 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, Provided that the symbol is
5.3.6, 5.3.7, 5.3.8, 5.3.9 provided on the sales packaging,
The ER is only covered in
respect of the conditions
indicated by the symbols. For
other conditions, other symbols
or other means of indication
may be needed.
15, 8th indent 5.2.8 Provided that the symbol is
provided in the instructions for
use, only the warning “do not
use the product, if the product
sterile barrier system or its
packaging is compromised” is
addressed.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
Annex ZC
(informative)
Relationship between this European standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request 'M/252,
concerning the development of European standards relating to in vitro diagnostic medical devices' to
provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the
European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [OJ L
331].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZC.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be
reduced “as far as possible”, “to a minimum”, “to the lowest possible level”, “minimized” or “removed”, according
to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.
NOTE 3 This Annex ZC is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZC.1, it means that it is not addressed by this
European Standard.
Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC on in
vitro diagnostic medical devices
Essential Requirements (ERs) Clause(s)/subclause(s) of this Qualifying remarks/Notes
of Directive 98/79/EC European Standard
B.8.2 4.2, Clause 5 Only the first two sentences of
this ER are covered with regard
to the use of symbols.
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SIST EN ISO 15223-1:2017
EN ISO 15223-1:2016 (E)
B.8.4 (a) 5.1.1, 5.1.2 In Directive 98/79/EC the
requirements of Annex I, ER
B.8.4(a) refer to the IVD device
label, which must show the
name and address of the
manufacturer and, where
necessary, also of the EC
authorised representative.
When the IVD device is a kit (i.e.
a set of several components
packaged together), the kit itself
shall be labelled as above with
the name and address of
manufacturer and, where
necessary, also of the EC
authorised representative.
B.8.4 (b) 5.1.3, 5.1.6, 5.5.2, 5.5.3, 5.5.4, The ER is only covered with
5.5.5 respect to the conditions
indicated by the symbols.
B.8.4 (c) 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5,
5.2.9
B.8.4 (d) 5.1.5, 5.1.7 If a Serial number is not
provided the symbol for 'LOT'
must precede the batch code.
B.8.4 (e) 5.1.4 The date must be expressed as
the year, the month and where
relevant the day, in that order.
B.8.4 (g) 5.5.1
B.8.4 (h) 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, The ER is only covered with
5.3.6, 5.3.7, 5.3.8, 5.3.9 respect to the conditions
indicated by the symbols.
B.8.4 (j) 5.2.6 , 5.2.8, 5.4.1, 5.4.2, 5.4.4, The ER is only covered with
5.4.5 respect to the conditions
indicated by the symbols.
B.8.6 5.1.5, 5.1.7
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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SIST EN ISO 15223-1:2017
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SIST EN ISO 15223-1:2017
INTERNATIONAL ISO
STANDARD 15223-1
Third edition
2016-11-01
Corrected version
2016-12-15
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)
©
ISO 2016
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SIST EN ISO 15223-1:2017
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
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copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 15223-1:2017
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
4.3 Other symbols . 3
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
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SIST EN ISO 15223-1:2017
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.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
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.
iv © ISO 2016 – All rights reserved
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SIST EN ISO 15223-1:2017
ISO 15223-1:2016(E)
Introduction
This document addresses the presentation of certain items of information that are considered by
regulatory authorities to be e
...
SLOVENSKI STANDARD
oSIST prEN ISO 15223-1:2015
01-oktober-2015
0HGLFLQVNLSULSRPRþNL6LPEROL]DR]QDþHYDQMHPHGLFLQVNLKSULSRPRþNRY
R]QDþHYDQMHLQSRGDWNLNLMLKPRUDSRGDWLGREDYLWHOMGHO 6SORãQH]DKWHYH
,62',6
Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2015)
Medizinprodukte - Bei Aufschriften von Medizinprodukten zu verwendende Symbole,
Kennzeichnung und zu liefernde Informationen - Teil 1: Allgemeine Anforderungen
(ISO/DIS 15223-1:2015)
Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les
informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
(ISO/DIS 15223-1:2015)
Ta slovenski standard je istoveten z: prEN ISO 15223-1
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 15223-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15223-1:2015
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oSIST prEN ISO 15223-1:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15223-1
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2015-08-06 2015-11-06
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
ICS: 01.080.20; 11.040.01
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15223-1:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015
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oSIST prEN ISO 15223-1:2015
ISO/DIS 15223-1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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oSIST prEN ISO 15223-1:2015
ISO/DIS 15223-1
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
4.3 Other symbols. 3
5 Symbols . 3
5.1 Manufacture . 4
5.2 Sterility . 8
5.3 Storage . 10
5.4 Safe use . 12
5.5 IVD-specific . 14
5.6 Transfusion/infusion . 15
5.7 Other . 17
Annex A (informative) Examples . 19
A.1 Example of use of symbol 5.1.1, “Manufacturer” . 19
A.2 Example of use of symbol 5.1.1, “Manufacturer”, combined with 5.1.3, “Date of
manufacture” . 19
A.3 Example of use of symbol 5.1.2, “Authorized representative in the European Community”. 19
A.4 Examples of use of symbol 5.1.3, “Date of manufacture” . 19
A.5 Examples of use of symbol 5.1.4, “Use-by date” . 20
A.6 Example of use of symbol 5.1.5, “Batch code” . 20
A.7 Example of use of symbol 5.1.6, “Catalogue number” . 20
A.8 Example of use of symbol 5.1.7, “Serial number” . 20
A.9 Examples of use of symbols for “Sterile fluid path” . 20
A.10 Examples of use of symbols for temperature limits . 21
A.11 Examples of use of symbol 5.3.8, “Humidity limitation” . 21
A.12 Example of use of symbol 5.3.9, “Atmospheric pressure limitation” . 21
A.13 Examples of use of symbol 5.5.5, “Contains sufficient for n tests” . 22
A.14 Example of use of symbol 5.7.1, “Patient number” . 22
A.15 Example of use of symbol 5.4.3, “Consult instructions for use” for an electronic
Instruction for Use (eIFU) . 22
Annex B (informative) Use of general prohibition symbol and negation symbol . 23
B.1 General prohibition symbol . 23
B.2 Negation symbol . 23
Bibliography . 24
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices . 25
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices . 28
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on In vitro Diagnostic Medical Devices . 30
1
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oSIST prEN ISO 15223-1:2015
ISO/DIS 15223-1
2 Foreword
3 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
4 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
5 technical committees. Each member body interested in a subject for which a technical committee has been
6 established has the right to be represented on that committee. International organizations, governmental and
7 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
8 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
9 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
10 The main task of technical committees is to prepare International Standards. Draft International Standards
11 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
12 International Standard requires approval by at least 75 % of the member bodies casting a vote.
13 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
14 rights. ISO shall not be held responsible for identifying any or all such patent rights.
15 ISO 15223-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
16 general aspects for medical devices.
17 This third edition cancels and replaces the second edition (ISO 15223-1:2012), which has been technically
18 revised. The principle revisions to the third edition are:
19 Clause 2 – update the title of ISO 7000 and add "date of release" for each of the registered symbols to
20 Table 1.
21 Symbol 5.1.1 – modify the requirement related to the placement of the manufacturer's name and address
22 on IVD labels.
23 Symbol 5.1.2 – modify the requirement related to the placement of name and address of the authorized
24 representative in the European Union on IVD labels.
25 Symbol 5.4.3 – add information used to indicate an instruction to consult an electronic instructions for use
26 (eIFU)
27 Symbol 5.4.5 – add reference to ISO 7000-2725, "Contains or presence of".
28 Annex A.15 – add examples of the placement of the eIFU indicator.
29 ISO 15223 consists of the following parts, under the general title Medical devices — Symbols to be used with
30 medical device labels, labelling and information to be supplied:
31 Part 1: General requirements
32 Part 2: Symbol development, selection and validation
33 NOTE Future symbols intended to appear in this part of ISO 15223 are to be validated in accordance with
34 ISO 15223-2.
iv © ISO 2015 – All rights reserved
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oSIST prEN ISO 15223-1:2015
ISO/DIS 15223-1
35 Introduction
36 This part of ISO 15223 addresses the presentation of certain items of information that are considered by
37 regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are
38 required to appear with the medical device in most regulatory domains. The information can be required to
39 appear on the medical device itself, as part of the label, or provided with the medical device.
40 Many countries require that their own language be used to display textual information with medical devices. At
41 the same time, manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This can
42 cause problems in relation to translation, design and logistics when multiple languages are included on a
43 single label or piece of documentation. For example, users of medical devices labelled in a number of different
44 languages can experience confusion and delay in locating the appropriate language.
45 This part of ISO 15223 proposes solutions to these problems through the use of internationally recognized
46 symbols with precisely defined descriptions.
47 While compiling symbols to be included in this part of ISO 15223, ISO/TC 210 recognized the need for
48 systematic methodology for the selection, development and validation of symbols proposed for adoption. This
49 is the subject of ISO 15223-2.
50 This part of ISO 15223 is primarily intended to be used by manufacturers of medical devices who market
51 identical products in countries where there are different language requirements for medical device labelling. It
52 can also be of assistance to:
53 distributors of medical devices or other representatives of manufacturers;
54 healthcare providers responsible for training as well as those being trained;
55 those responsible for post-market vigilance;
56 healthcare regulatory authorities, testing organizations, certification bodies and other organizations which
57 are responsible for implementing regulations affecting medical devices and which have responsibility for
58 post-market surveillance; and
59 consumers or end users of medical devices who draw their supplies from a number of sources and can
60 have varied language capabilities.
61
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oSIST prEN ISO 15223-1:2015
ISO/DIS 15223-1
62 Medical Devices — Symbols to be used with medical device
63 labels, labelling and information to be supplied — Part 1:
64 General requirements
65 1 Scope
66 This part of ISO 15223 identifies requirements for symbols used in medical device labelling that convey
67 information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements
68 of this part of ISO 15223.
69 This part of ISO 15223 is applicable to symbols used in a broad spectrum of medical devices, which are
70 marketed globally and therefore need to meet different regulatory requirements.
71 These symbols may be used on the medical device itself, on its packaging or in the associated documentation.
72 The requirements of this part of ISO 15223 are not intended to apply to symbols specified in other standards.
73 2 Normative references
74 The following documents, in whole or in part, are normatively referenced in this document and are
75 indispensable for its application. For dated references, only the edition cited applies. For undated references,
76 the latest edition of the referenced document (including any amendments) applies.
1)
77 ISO 7000, Graphical symbols for use on equipment — Registered symbols
78 ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
79 times
80 ISO 14971, Medical devices — Application of risk management to medical devices
81 ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling and information to
82 be supplied — Part 2: Symbol development, selection and validation
83 3 Terms and definitions
84 For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.
85 3.1
86 characteristic information
87 information that represents the property or properties of a symbol
88 3.2
89 description
90 normative text which defines the purpose, application and use of the symbol
91 NOTE Adapted from IEC 80416-1:2008, definition 3.2.
1)
Available only in database format from ISO or IEC. Each symbol in the database has a "date of release". These dates
are given in the ISO Registration Number column in Table 1.
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ISO/DIS 15223-1
92 3.3
93 label
94 written, printed or graphic information provided upon the medical device itself
95 NOTE Adapted from GHTF/SG1/N43:2005.
96 3.4
97 labelling
98 information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device
99 or any of its containers or wrappers
100 NOTE 1 This information relates to the identification, technical description and use of the medical device, but excludes
101 shipping documents.
102 NOTE 2 Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”.
103 3.5
104 symbol used in medical device labelling
105 graphical representation appearing on the label and/or associated documentation of a medical device that
106 communicates characteristic information without the need for the supplier or receiver of the information to
107 have knowledge of the language of a particular nation or people
108 NOTE The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects,
109 including alphanumeric characters.
110 3.6
111 title
112 unique name by which a graphical symbol is identified and spoken of
113 NOTE Adapted from IEC 80416-1:2008, definition 3.9.
114 4 General requirements
115 4.1 Proposal of symbols for adoption
116 Symbols proposed for adoption in this part of ISO 15223 shall be validated in accordance with ISO 15223-2.
117 Any symbol proposed for adoption in this part of ISO 15223 shall be applicable to a range of medical devices
118 and have global or regional applicability.
119 4.2 Requirements for usage
120 When risk management shows it to be appropriate for symbols to be used to convey information essential for
121 proper use on the medical device, its packaging or in associated documentation, the symbols given in Table 1
122 may be used.
123 Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000,
124 especially with respect to relative dimensions, including relative line thickness, orientation and the absence or
125 presence of filled or shaded areas.
126 NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains
127 the complete set of graphical symbols included in ISO 7000 and IEC 60417. In that database, each graphical symbol is
128 identified by a reference number and contains a title (in English and French), a graphical representation in GIF and
129 vectorised PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy
130 retrieval of graphical symbols. Information on how to subscribe in order to access this database is available through the
131 ISO Store, the IEC Web Store or by contacting your local national standards body.
132 As part of risk management, the manufacturer should determine the appropriate size for the symbol to be
133 legible for its intended function.
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ISO/DIS 15223-1
134 NOTE 2 This part of ISO 15223 does not specify colours or minimum size for the symbols in Table 1, nor does it
135 specify the relative size of symbols and that of indicated information.
136 It is important that symbols be used properly. Guidance on appropriate use of the general prohibition symbol
137 and the negation symbol is given in Annex B.
138 Before symbols are used, the manufacturer shall carry out a risk assessment that indicates that the use of the
139 symbol does not introduce an unacceptable risk.
140 NOTE 3 Additional information regarding risk assessment can be found in ISO 14971.
141 Symbols may be used without accompanying text. Where regulations require accompanying text, the title of
142 the symbol given in this part of ISO 15223 should be considered sufficient. All dates and times presented in
143 association with symbols shall use the conventions set out in ISO 8601.
144 4.3 Other symbols
145 Other standards specify additional symbols that are applicable to particular kinds or groups of medical devices
146 or to particular situations. Examples of sources for such symbols are identified in the Bibliography. This listing
147 is not exhaustive.
148 5 Symbols
149 When appropriate, information essential for proper use shall be indicated on the medical device, its packaging,
150 or in the associated documentation by using the corresponding symbols given in Table 1.
151 A manufacturer may use any appropriate symbol regardless of category.
152 NOTE Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is
153 grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the
154 categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.
© ISO 2015 – All rights reserved 3
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155 Table 1 — Symbols to convey information essential for proper use
ISO 7000
Reference number Description of
Title of symbol Requirements Informative notes Restrictions of use Additional requirements
a
of symbol symbol Reg. no.
5.1 Manufacture
NOTE 1 This symbol is used
5.1.1 Manufacturer Indicates the This symbol shall be 3082
to indicate information that is
medical device accompanied by the name
2011-10-03
b
required in Europe .
manufacturer, as and address of the
defined in EU manufacturer (i.e. the
NOTE 2 The full definition of
Directives person placing the medical
“manufacturer” is given in EU
90/385/EEC, device on the market),
Directives 90/385/EEC,
93/42/EEC and adjacent to the symbol. 93/42/EEC and 98/79/EC.
98/79/EC.
According to the IVD NOTE 3 Guidance on the
requirements for EU Directives
labelling standards
90/385/EEC and 93/42/EEC is
ISO 18113-2 and
given in EN 1041.
ISO 18113-4, the address
is required only on the
NOTE 4 The date of
device label, and, in case manufacture, as well as the
of an IVD kit, on the kit name and address of the
manufacturer, can be
label, i.e. the outer
combined in one symbol.
container label. By
contrast, the address is not
NOTE 5 The relative size of
required with the symbol
the symbol and the size of the
on the label of the kit name and address are not
component immediate specified.
container, except when
this immediate container is
in practice the outer
container, i.e. the kit
container.
156
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oSIST prEN ISO 15223-1:2015
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157 Table 1 (continued)
ISO 7000
Reference number Description of
Title of symbol Requirements Informative notes Restrictions of use Additional requirements
a
of symbol symbol Reg. no.
5.1.2 NOTE 1 This symbol is used
Authorized Indicates the This symbol shall be N/A
to indicate information that is
representative Authorized accompanied by the name
required in the European
in the European representative in the and address of the
Community.
Community European authorized representative
Community. in the European NOTE 2 Guidance on the
Community, adjacent to requirements for EU Directives
90/385/EEC and 93/42/EEC is
the symbol.
given in EN 1041.
According to the IVD
NOTE 3 The relative size of
labelling standards
the symbol and the size of the
ISO 18113-2 and
name and address are not
ISO 18113-4, the address
specified.
is required only on the
device label, and, in case
of an IVD kit, on the kit
label, i.e. the outer
container label. By
contrast, the address is not
required with the symbol
on the label of the kit
component immediate
container, except when
this immediate container is
in practice the outer
container, i.e. the kit
container.
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oSIST prEN ISO 15223-1:2015
ISO/DIS 15223-1
158 Table 1 (continued)
ISO 7000
Reference number Description of
Title of symbol Requirements Informative notes Restrictions of use Additional requirements
a
of symbol symbol Reg. no.
b
5.1.3 NOTE 1 The relative size of
Date of Indicates the date This symbol shall be In Europe : 2497
the symbol and the size of the
manufacture when the medical accompanied by a date to
2004-01-15
the date could be a
date are not specified.
device was indicate the date of
year, year and month,
manufactured. manufacture. This shall be
NOTE 2 This symbol can be
or year, month and
expressed as in ISO 8601 filled or unfilled. If filled, the
day, as required in the
as four digits for the year date of manufacture as well as
relevant EU Directive;
the name and address of the
and, where appropriate,
this symbol may be
manufacture can be combined
two digits for the month
used to identify the
in one symbol.
and two digits for the day.
month and year of
The date shall be located
manufacture for active
adjacent to the symbol.
implantable medical
devices, or the year of
manufacture for active
medical devices where
no use by date is
given, as required by
the appropriate EU
Directive.
b
5.1.4 Use-by date Indicates the date This symbol shall be NOTE 1 For example, 2607
In Europe :
June 2002 is expressed as
after which the accompanied by a date to 2004-01-15
the date could be a
2002-06.
medical device is indicate that the medical
year, year and month,
not to be used. device should not be used
NOTE 2 The relative size of
or year, month and
after the end of the year,
the symbol and the size of the
day, as required by the
month or day shown. date are not specified.
relevant EU Directive;
The date shall be NOTE 3 Synonym for “use-by
this symbol can be
date” is “use by”.
expressed as in ISO 8601
used to identify the
as four digits for the year
NOTE 4 For some medical
time limit for implanting
and, where appropriate,
devices (e.g. IVDs), this date
an active implantable
two digits for the month
is only valid when the medical
medical device safely
and two digits for the day. device is unopened.
as required by EU
Directive 90/385/EEC.
The date shall be located
adjacent to the symbol.
6 © ISO 2015 – All rights reserved
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159 Table 1 (continued)
ISO 7000
Reference number Description of
Title of symbol Requirements Informative notes Restrictions of use Additional requirements
a
of symbol symbol Reg. no.
5.1.5 NOTE 1 The relative size of
Batch code Indicates the This symbol shall be 2492
the symbol and the size of the
manufacturer's accompanied by the
2004-01-15
batch code are not specified.
batch code so that manufacturer's batch code.
the batch or lot can The batch code shall be
NOTE 2 Synonyms for “batch
be identified. adjacent to the symbol. code” are “lot number” and
“batch number”.
b
5.1.6 Catalogue Indicates the The manufacturer's NOTE 1 The relative size of 2493
In Europe , the
number manufacturer's catalogue number shall be the symbol and the size of the
manufacturer's catalogue 2004-01-15
catalogue number are not
catalogue number adjacent to the symbol.
number shall be placed after
specified.
so that the medical
or below the symbol and
device can be
NOTE 2 Synonyms for adjacent to it. This symbol
identified.
“catalogue number” are may currently be shown
“reference number” and
without the enclosure;
“reorder number”.
however, it is intended that
this option be withdrawn in a
future edition of this part of
ISO 15223.
b
5.1.7 Serial number Indicates the This symbol shall be NOTE The relative
...
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