EN ISO 20417:2021
(Main)Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen (ISO 20417:2021, korrigierte Fassung 2021-12)
ANMERKUNG 1 Eine Anleitung oder Begründung für diesen Abschnitt ist in Abschnitt A.2 enthalten.
Dieses Dokument legt die Anforderungen an vom Hersteller bereitzustellende Informationen für ein Medizinprodukt oder Zubehör, wie in 3.1 definiert, fest. Dieses Dokument enthält die allgemein anwendbaren Anforderungen an die Identifizierung und die Etiketten auf einem Medizinprodukt oder Zubehör, an die Verpackung, an die Kennzeichnung eines Medizinprodukts oder Zubehörs und an die Begleitinformationen. Dieses Dokument legt nicht fest, auf welche Art und Weise die Informationen bereitzustellen sind.
ANMERKUNG 2 Einige zuständige Behörden stellen andere Anforderungen an die Identifizierung, Kennzeichnung und Dokumentation eines Medizinprodukts oder Zubehörs.
Spezifische Anforderungen von Produktnormen oder Gruppennormen zu Medizinprodukten haben Vorrang vor den Anforderungen dieses Dokuments.
Dispositifs médicaux - Informations à fournir par le fabricant (ISO 20417:2021, Version corrigée 2021-12)
NOTE 1 Il y a des indications ou une justification pour cet Article figurant dans l'Article A.2.
Le présent document spécifie les exigences relatives aux informations fournies par le fabricant pour un dispositif médical ou un accessoire, tel que défini en 3.1. Le présent document contient les exigences génériques communes concernant l’identification et l’étiquetage d’un dispositif médical ou d’un accessoire, l'emballage, le marquage d’un dispositif médical ou d’un accessoire et les informations d’accompagnement. Le présent document ne spécifie pas le mode de transmission des informations.
NOTE 2 Certaines autorités compétentes imposent des exigences différentes concernant l’identification, le marquage et la documentation d’un dispositif médical ou d’un accessoire.
Les exigences spécifiques des normes de produit relatives à un dispositif médical ou des normes de groupe prévalent sur les exigences du présent document.
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2021, popravljena verzija 2021-12)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2021
Nadomešča:
SIST EN 1041:2008+A1:2013
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2021)
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO
20417:2021)
Dispositifs médicaux - Informations à fournir par le fabricant (ISO 20417:2021)
Ta slovenski standard je istoveten z: EN ISO 20417:2021
ICS:
01.110 Tehnična dokumentacija za Technical product
izdelke documentation
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 20417
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2021
ICS 11.040.01
Supersedes EN 1041:2008+A1:2013
English version
Medical devices - Information to be supplied by the
manufacturer (ISO 20417:2021)
Dispositifs médicaux - Informations à fournir par le Medizinprodukte - Anforderungen an allgemeine
fabricant (ISO 20417:2021) Informationen des Herstellers (ISO 20417:2021)
This European Standard was approved by CEN on 30 June 2020.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 20417:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20417:2021) 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/JTC 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 November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1041:2008+A1:2013.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20417:2021 has been approved by CEN as EN ISO 20417:2021 without any modification.
INTERNATIONAL ISO
STANDARD 20417
First edition
2021-04
Medical devices — Information to be
supplied by the manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
Reference number
ISO 20417:2021(E)
©
ISO 2021
ISO 20417:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 20417:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General considerations . 9
5 Information elements to be established .10
5.1 Units of measurement . .10
5.2 Graphical information .10
5.3 Language and country identifiers .11
5.3.1 Language identifiers .11
5.3.2 Country identifiers .11
5.4 Dates .11
5.5 Full address .12
5.6 Commercial product name .12
5.7 Model number .12
5.8 Catalogue number .12
5.9 Production controls .12
5.10 Unique device identifier .13
5.11 Types of use/reuse .13
5.12 Sterile .13
6 Requirements for accompanying information .13
6.1 Requirements for information to be supplied on the label .13
6.1.1 Minimum requirements for the label . .13
6.1.2 Identification of the manufacturer .14
6.1.3 Identification of the medical device or accessory .15
6.1.4 Other label requirements .17
6.1.5 Consult instructions for use .18
6.1.6 Safety signs .19
6.2 Identification requirements for detachable components of a medical device or
accessory .20
6.3 Legibility of the label .20
6.4 Durability of markings .20
6.5 Information to be provided on the packaging.21
6.5.1 General information .21
6.5.2 Packaging for the lay user .22
6.5.3 Special conditions indicated on the packaging .23
6.6 Requirements for information in the instructions for use and technical description .24
6.6.1 General.24
6.6.2 Requirements for instructions for use .25
6.6.3 Additional requirements for the instructions for use for a lay user .30
6.6.4 Requirements for technical description .30
6.6.5 Requirements for e-documentation .33
7 Other information that is required to be supplied with the medical device or accessory .33
7.1 Importer .33
7.2 Distributor .33
7.3 Repackaging .34
7.4 Translation.34
7.5 Regulatory identification .35
Annex A (informative) Particular guidance and rationale .
...
SLOVENSKI STANDARD
01-julij-2021
Nadomešča:
SIST EN 1041:2008+A1:2013
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2021,
popravljena verzija 2021-12)
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen
(ISO 20417:2021, korrigierte Fassung 2021-12)
Dispositifs médicaux - Informations à fournir par le fabricant (ISO 20417:2021, Version
corrigée 2021-12)
Ta slovenski standard je istoveten z: EN ISO 20417:2021
ICS:
01.110 Tehnična dokumentacija za Technical product
izdelke documentation
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 20417
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2021
ICS 11.040.01
Supersedes EN 1041:2008+A1:2013
English version
Medical devices - Information to be supplied by the
manufacturer (ISO 20417:2021, Corrected version
2021-12)
Dispositifs médicaux - Informations à fournir par le Medizinprodukte - Anforderungen an vom Hersteller
fabricant (ISO 20417:2021, Version corrigée 2021-12) bereitzustellende Informationen (ISO 20417:2021,
korrigierte Fassung 2021-12)
This European Standard was approved by CEN on 30 June 2020.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 22 December 2021.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 20417:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 20417:2021) 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/JTC 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 November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1041:2008+A1:2013.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20417:2021, Corrected version 2021-12 has been approved by CEN as
INTERNATIONAL ISO
STANDARD 20417
First edition
2021-04
Corrected version
2021-12
Medical devices — Information to be
supplied by the manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
Reference number
ISO 20417:2021(E)
ISO 20417:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 20417:2021(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General considerations .9
5 Information elements to be established .10
5.1 Units of measurement . 10
5.2 Graphical information . 10
5.3 Language and country identifiers . 11
5.3.1 Language identifiers . 11
5.3.2 Country identifiers . 11
5.4 Dates . 11
5.5 Full address .12
5.6 Commercial product name .12
5.7 Model number .12
5.8 Catalogue number .12
5.9 Production controls .12
5.10 Unique device identifier .13
5.11 Types of use/reuse . 13
5.12 Sterile . 13
6 Requirements for accompanying information .13
6.1 Requirements for information to be supplied on the label .13
6.1.1 Minimum requirements for the label . 13
6.1.2 Identification of the manufacturer . 14
6.1.3 Identification of the medical device or accessory . 15
6.1.4 Other label requirements . 17
6.1.5 Consult instructions for use . 18
6.1.6 Safety signs . 19
6.2 Identification requirements for detachable components of a medical device or
accessory . 20
6.3 Legibility of the label .20
6.4 Durability of markings . 20
6.5 Information to be provided on the packaging . 21
6.5.1 General information . 21
6.5.2 Packaging for the lay user . 22
6.5.3 Special conditions indicated on the packaging . 23
6.6 Requirements for information in the instructions for use and technical description . 24
6.6.1 General . 24
6.6.2 Requirements for instructions for use . 25
6.6.3 Additional requirements for the instructions for use for a lay user .30
6.6.4 Requirements for technical description .30
6.6.5 Requirements for e-documentation . 33
7 Other information that is required to be supplied with the medical device or
accessory .33
7.1 Importer . 33
7.2 Distributor . 33
7.3 Repackaging .
...
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