EN ISO 15223-1:2016

SLOVENSKI STANDARD
01-februar-2017
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SIST EN ISO 15223-1:2012
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.
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
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,
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.
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.
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.
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.
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 Dir
...