Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)

2021-04-26_JO: BT N 12459 and BT168/DG12120/DV to decouple from  Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations 2017/745

Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO 20417:2021)

Dieses Dokument legt die Anforderungen an vom Hersteller bereitgestellte Informationen für ein Medizinprodukt oder Zubehör nach 3.1 fest. Dieses Dokument enthält die allgemein anwendbaren Anforderungen an die Identifizierung und die Etiketten auf einem Medizinprodukt oder Zubehör, an dessen 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 Einige zuständige Behörden stellen andere Anforderungen an die Identifizierung, Kennzeichnung und Dokumentation eines Medizinproduktes oder Zubehörs.
Spezielle 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)

Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2021)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
05-May-2021
Completion Date
05-May-2021

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SLOVENSKI STANDARD
SIST EN ISO 20417:2021
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
SIST EN ISO 20417:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20417:2021
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SIST EN ISO 20417:2021
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.
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SIST EN ISO 20417:2021
EN ISO 20417:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 20417:2021
EN ISO 20417:2021 (E)
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.

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SIST EN ISO 20417:2021
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SIST EN ISO 20417:2021
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
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SIST EN ISO 20417:2021
ISO 20417:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 20417:2021
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 ..........................................................................................................36

Annex B (informative) Example test method for assessing clearly legible requirements..........................39

© ISO 2021 – All rights reserved iii
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SIST EN ISO 20417:2021
ISO 20417:2021(E)

Annex C (informative) Example test method for assessing durability ...........................................................................40

Annex D (informative) Cross reference between the document and the requirements

considered ................................................................................................................................................................................................................41

Annex E (informative) Reference to the IMDRF essential principles and labelling guidances ...............53

Annex F (informative) Reference to the essential principles ....................................................................................................57

Annex G (informative) Reference to the general safety and performance requirements for

medical devices ....................................................................................................................................................................................................61

Annex H (informative) Reference to the general safety and performance requirements for

IVD medical devices .........................................................................................................................................................................................65

Annex I (informative) Terminology — Alphabetized index of defined terms .........................................................69

Bibliography .............................................................................................................................................................................................................................71

iv © ISO 2021 – All rights reserved
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SIST EN ISO 20417:2021
ISO 20417:2021(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 of the voluntary nature of standards, 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 www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding

general aspects for medical devices in collaboration with the European Committee for Standardization

(CEN/CLC) Technical Committee CEN/ CLC JTC 3, Quality management and corresponding general aspects

for medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN

(Vienna Agreement).

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 20417:2021
ISO 20417:2021(E)
Introduction

This document provides the requirements for the identification and labels on a medical device or

accessory, the packaging, marking of a medical device or accessory, and accompanying information. The

aim of this document is to serve as a central source of these common, generally applicable requirements,

allowing each specific product standard or group standard to focus more concisely on the unique

requirements for a specific medical device or group of medical devices.

The requirements of a medical device product standard or a group standard can make use of these

general requirements. Where there is a conflict and a product standard or a group standard exists, this

document should not be used separately. Specific requirements of medical device product standards

or group standards take precedence over requirements of this document. Unless specified otherwise

within a product standard or a group standard, the general requirements of this document apply.

Some authorities having jurisdiction have requirements that can differ from the requirements of this

document.
This document has been prepared in consideration of:

— the application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical

[3]

Devices, IMDRF/GRRP WG/N47: 2018 on the information supplied by the manufacturer of a medical

device (see Annex D);

— the application of Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/

[4]

N52: 2019 on the information supplied by the manufacturer of a medical device (see Annex E);

— the application of the essential principles of safety and performance on the information supplied by the

manufacturer of a medical device according to ISO 16142-1:2016 (see Annex F);

— the application of the essential principles of safety and performance on the information supplied by the

manufacturer of an IVD medical device according to ISO 16142-2:2017 (see Annex F);

— the general safety and performance requirements for the information supplied by the manufacturer

[5]
of a medical device according to regulation (EU) 2017/745 (see Annex G); and

— the general safety and performance requirements for the information supplied by the manufacturer

[6]
of a medical device according to regulation (EU) 2017/746 (see Annex H).

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.

Requirements in this document have been decomposed so that each requirement is uniquely delineated.

This is done to support automated requirements tracking.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 20417:2021
INTERNATIONAL STANDARD ISO 20417:2021(E)
Medical devices — Information to be supplied by the
manufacturer
1 Scope
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.
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 references, the latest edition of the referenced document (including any amendments) applies.

ISO 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes

ISO 3864-1:2011, Graphical symbols — Safety colours and safety signs — Part 1: Design principles for

safety signs and safety markings
ISO 7000, Graphical symbols for use on equipment — Registered symbols

ISO 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs

ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules

ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 14971:2019, Medical devices — Application of risk management to medical devices

ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements

ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of medical

devices — Part 1: General essential principles and additional specific essential principles for all non-IVD

medical devices and guidance on the selection of standards

ISO 16142-2:2017, Medical devices — Recognized essential principles of safety and performance of medical

devices — Part 2: General essential principles and additional specific essential principles for all IVD medical

devices and guidance on the selection of standards
IEC 60417, (database), Graphical symbols for use on equipment

IEC 62366-1:2015+AMD1: 2020, Medical devices — Part 1: Application of the usability engineering process

to medical devices
1) Under preparation. Stage at the time of publication: ISO/FDIS 15223-1:2021.
© ISO 2021 – All rights reserved 1
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SIST EN ISO 20417:2021
ISO 20417:2021(E)
ISO 80000-1, Quantities and units — Part 1: General
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 13485:2016, ISO 14971:2019,

ISO 16142-1:2016, ISO 16142-2:2017 and IEC 62366-1:2015+AMD1: 2020 as specified in Annex I and the

following definitions apply. ISO and IEC maintain terminological databases for use in standardization at

the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/

NOTE An alphabetized index of defined terms used in this document is found in Annex I.

3.1
accessory

item, intended specifically by its manufacturer, to be used together with one or more medical devices to

specifically enable or assist those medical devices to be used in accordance with their intended use

Note 1 to entry: An accessory is typically a consumable or separate item for use with one or more medical devices.

Note 2 to entry: Note 2 to entry: Some authorities having jurisdiction consider an accessory to be a medical device.

Note 3 to entry: Some authorities having jurisdiction have a different definition of accessory.

3.2
accompanying information

information accompanying or marked on a medical device or accessory (3.1) for the user or those

accountable for the installation, use, processing, maintenance, decommissioning and disposal of the

medical device or accessory, particularly regarding safe use

Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.

Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical

description, installation manual, quick reference guide, etc.

Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve

auditory, visual, or tactile materials and multiple media types (e.g., CD/DVD-ROM, USB stick, website).

Note 4 to entry: See Figure 1.
2 © ISO 2021 – All rights reserved
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SIST EN ISO 20417:2021
ISO 20417:2021(E)

Note 5 to entry The label can include the information on the packaging of the medical device.

Note 6 to entry e-documentation can include any or all types of information supplied by the manufacturer partially

or entirely.
Note 7 to entry Marketing information is also known as promotional material.

Figure 1 — Relationship of terms used to describe information supplied by the manufacturer

3.3
catalogue number
commercial product name
commercial product code

value given by the manufacturer to identify a specific medical device or accessory (3.1) as it relates to its

form/fit, function and process (i.e., manufacturing processes requiring differentiation for the end user)

Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these.

Note 2 to entry: For the purposes of this document, commercial product code should not be confused with the US

FDA ‘product code’ or procode classification.

Note 3 to entry: Synonyms for catalogue number are "reference number" or "reorder number".

Note 4 to entry: See Figure 2.
[4]

[SOURCE: IMDRF/GRRP WG/N52: 2019 , 3.2, modified — added ‘or accessory’ and Notes to entry.]

© ISO 2021 – All rights reserved 3
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SIST EN ISO 20417:2021
ISO 20417:2021(E)
At least one of these conditional distinct product identifiers is required.

Figure 2 — Relationship of terms used to describe distinct product identification

3.4
clearly legible
easily legible
capable of being read by a person with normal vision

Note 1 to entry: There is guidance or rationale for this definition contained in Clause A.2.

[2]
[SOURCE: IEC 60601-1:2005+AMD1: 2012 , 3.15, modified — Note 1 to entry added.]
3.5
distributor

natural or legal person, different from the manufacturer or importer, in the supply chain who, on their

own behalf, furthers the availability of a medical device or accessory (3.1) to the user

Note 1 to entry: More than one distributor may be involved in the supply chain.

Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as

storage and transport on beh
...

SLOVENSKI STANDARD
oSIST prEN ISO 20417:2019
01-maj-2019
0HGLFLQVNLSULSRPRþNL,QIRUPDFLMHNLMLKSULGRELSURL]YDMDOHF ,62',6


Medical Devices - Information to be provided by the manufacturer (ISO/DIS 20417:2019)

Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO/DIS

20417:2019)

Dispositifs médicaux - Informations à fournir par le fabricant (ISO/DIS 20417:2019)

Ta slovenski standard je istoveten z: prEN ISO 20417
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 20417:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 20417:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 20417:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20417
ISO/TC 210 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-03-19 2019-06-11
Medical devices — Information to be provided by the
manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
ICS: 11.040.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
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 20417:2019(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 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
© ISO 2019 – All rights reserved 3
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oSIST prEN ISO 20417:2019
ISO/DIS 20417:2019(E)
1 Contents

2 Foreword .......................................................................................................................................................................... 6

3 Introduction..................................................................................................................................................................... 7

4 1 Scope .................................................................................................................................................................... 8

5 2 Normative references .................................................................................................................................... 8

6 3 Terms and definitions................................................................................................................................. 10

7 4 General process requirements ................................................................................................................. 16

8 4.1 Usability ............................................................................................................................................................................... 16

9 4.2 Risk management ............................................................................................................................................................. 17

10 5 General requirements ................................................................................................................................ 17

11 5.1 Units of measurement .................................................................................................................................................... 17

12 5.2 Symbols and colours ....................................................................................................................................................... 17

13 5.3 Language and country identifiers ............................................................................................................................. 18

14 5.3.1 Language identifiers ....................................................................................................................................................... 18

15 5.3.2 Country identifiers .......................................................................................................................................................... 18

16 5.4 Dates ..................................................................................................................................................................................... 18

17 5.5 Full address ....................................................................................................................................................................... 19

18 5.6 Authorized representative ........................................................................................................................................... 19

19 6 Medical device identification .................................................................................................................... 19

20 6.1 Commercial product name ........................................................................................................................................... 19

21 6.2 Model number .................................................................................................................................................................... 19

22 6.3 Catalogue number ............................................................................................................................................................ 19

23 6.4 Software .............................................................................................................................................................................. 20

24 6.5 Production identifier ..................................................................................................................................................... 20

25 6.6 Unique device identification ....................................................................................................................................... 20

26 6.7 Types of reuse ................................................................................................................................................................... 20

27 6.8 Sterile ................................................................................................................................................................................... 21

28 7 Requirements for packaging .................................................................................................................... 21

29 7.1 General packaging ........................................................................................................................................................... 21

30 7.2 Packaging for lay user .................................................................................................................................................... 23

31 7.3 Special conditions indicated on packaging ............................................................................................................ 23

32 8 Requirements for information on the label and marking.............................................................. 24

33 8.1 Requirements for the label .......................................................................................................................................... 24

34 8.1.1 Minimum requirements for the label ....................................................................................................................... 24

35 8.1.2 Identification of the manufacturer ............................................................................................................................ 25

36 8.1.3 Identification of the medical device or accessory ................................................................................................. 25

37 8.1.4 Additional label requirements ................................................................................................................................... 27

38 8.2 Consult instructions for use .......................................................................................................................................... 29

39 8.3 Safety signs ......................................................................................................................................................................... 29

40 8.4 Legibility of the label and markings ......................................................................................................................... 30

41 8.5 Durability of markings ................................................................................................................................................... 30

42 9 Requirements for accompanying documentation ............................................................................. 31

43 9.1 General ................................................................................................................................................................................ 31

44 9.2 Health technology assessment (HTA) ...................................................................................................................... 32

45 9.3 Requirements for instructions for use ..................................................................................................................... 32

46 9.3.1 General ................................................................................................................................................................................ 32

47 9.3.2 Requirements for E-documentation .......................................................................................................................... 35

48 9.4 Requirements for technical description .................................................................................................................. 36

4 © ISO 2019 – All rights reserved
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49 10 Information supplied by the manufacturer .......................................................................................... 38

50 10.1 Importer .............................................................................................................................................................................. 38

51 10.2 Distributor .......................................................................................................................................................................... 38

52 Annex A (informative) Particular guidance and rationale ......................................................................... 39

53 Annex B (informative) Symbols and safety signs for marking .................................................................. 42

54 Annex C (informative) Reference to the IMDRF essential principles and labelling guidance ........ 48

55 Annex D (informative) Reference to the essential principles .................................................................... 53

56 Annex E (informative) Terminology — Alphabetized index of defined terms .................................... 58

57 Annex ZA (informative) Relationship between this European standard and the essential

58 requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered .............................................. 61

59 Annex ZB (informative) Relationship between this European standard and the essential

60 requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .................................................. 64

61 Annex ZC (informative) Relationship between this European standard and the essential

62 requirements of Directive 98/79/EC [OJ L 331] aimed to be covered ................................................... 67

63 Annex ZD (informative) Relationship between this European standard and the General Safety and

64 Performance Requirements of Regulation (EU) 2017/745 aimed to be covered ............................... 70

65 Annex ZE (informative) Relationship between this Document and the General Safety and

66 Performance Requirements of Regulation (EU) 2017/746 aimed to be covered ............................... 75

67 Bibliography ................................................................................................................................................................. 82

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69 Foreword

70 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

71 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO

72 technical committees. Each member body interested in a subject for which a technical committee has been

73 established has the right to be represented on that committee. International organizations, governmental and

74 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

75 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

76 The procedures used to develop this document and those intended for its further maintenance are described in

77 the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO

78 documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC

79 Directives, Part 2. www.iso.org/directives

80 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

81 rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights

82 identified during the development of the document will be in the Introduction and/or on the ISO list of patent

83 declarations received. www.iso.org/patents

84 Any trade name used in this document is information given for the convenience of users and does not constitute

85 an endorsement.

86 For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as

87 well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade (TBT) see

88 the following URL: Foreword - Supplementary information

89 ISO 20417 was prepared by a Technical Committee ISO/TC 210, Quality management and corresponding

90 general aspects for medical devices.
This is the first edition of ISO 20417.
ISO 20417 replaces EN 1041 [1] .
Numbers in square brackets refer to the Bibliography.
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94 Introduction

95 This standard provides the common, generic requirements for the design and implementation of labels on

96 medical devices or their packaging, marking of medical devices or accompanying documentation.

97 This document is intended to replace or supplement the often-repetitive labelling requirements that are

98 common among the existing product standards of medical devices. The aim of this document is to serve as a

99 central source of these common, generic requirements, allowing each specific product standard in the future to

100 focus more concisely on the unique requirements for a specific medical device.

101 The requirements of a medical device-specific product standard either supplement or modify these general

102 requirements. Where a product standard exists, this document should not be used separately. Unless specified

103 otherwise within a product standard, the general requirements of this document apply.

104 This document has been prepared to support the essential principles of safety and performance for the

105 information supplied by the manufacturer of a medical device according to ISO 16142 (series).

106 In this document, the following print types are used:
107  Requirements and definitions: roman type.

108  Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative

109 text of tables is also in a smaller type.

110  Test specifications and terms defined in clause 3 of this document or as noted: italic type.

111 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of

112 the conditions is true.

113 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part

114 2. For the purposes of this document, the auxiliary verb:

115  “shall” means that conformance with a requirement or a test is mandatory for conformance with this

116 document;

117  “should” means that conformance with a requirement or a test is recommended but is not mandatory for

118 conformance with this document;

119  “may” is used to describe permission (e.g. a permissible way to achieve conformance with a requirement

120 or test);
121  "can" is used to describe a possibility or capability; and
122  "must" is used to express an external constraint.

123 Annex B contains a compendium of the symbols and safety signs referenced in this document.

124 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there

125 is guidance or rationale related to that item in Annex A.
126
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127 Medical Devices — Information to be provided by the manufacturer
128 1 * Scope

129 This document specifies the requirements for information supplied by the manufacturer for a medical device or

130 accessory, as defined in 3.1. This document includes the generally applicable requirements for identification,

131 marking and documentation of a medical device or accessory. This document does not specify the language to

132 be used for such information, nor does it specify the means by which the information is to be supplied.

133 This document has been prepared to support:

134  the essential principles of safety and performance for the information supplied by the manufacturer of a

135 medical device according to ISO 16142-1:2016 (see Annex C); and

136  the essential principles of safety and performance for the information supplied by the manufacturer of an

137 IVD medical device according to ISO 16142-2:2017 (see Annex C);
138  IMDRF/GRRP WG/N47:2018 [3] (see Annex D); and
139  IMDRF/GRRP WG/N52:— [4] (see Annex D).

140 NOTE Some authorities with jurisdiction impose additional requirements for the identification, marking and

141 documentation of a medical device or accessory.

142 The requirements of a medical device-specific product standard take priority over this document.

143 2 Normative references

144 The following documents, in whole or in part, are normatively referenced in this document and are

145 indispensable for its application. For dated references, only the edition cited applies. For undated references,

146 the latest edition of the referenced document (including any amendments) applies.

147 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in

148 whole or in part) to which they apply.
149 NOTE 2 Informative references are listed in the bibliography.

150 ISO/IEC 646, Information technology – ISO 7-bit coded character set for information interchange

151 ISO 639-1:2002, Codes for the representation of names of languages – Part 1: Alpha-2 Code

152 ISO 639-2:1998, Codes for the representation of names of languages – Part 2: Alpha-3 code

153 ISO 639-3:2007, Codes for the representation of names of languages – Part 3: Alpha-3 code for comprehensive

154 coverage of languages

155 ISO 3166-1:2013, Codes for the representation of names of countries and their subdivisions – Part 1: Country codes

156 ISO 3864-1:2011, Graphical symbols. Safety colours and safety signs. Part 1: Design principles for safety signs and

157 safety markings
158 ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols
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159 ISO 7010:2011, Graphical symbols – Safety colours and safety signs – Registered safety signs

160 +Amendment 1:2012
161 +Amendment 2:2012
162 +Amendment 3:2012
163 +Amendment 4:2013
164 +Amendment 5:2014
165 +Amendment 6:2014
166 +Amendment 7:2016
167 +Amendment 8:2017
168 +Amendment 9:2018

169 ISO 8601:2004, Data elements and interchange formats – Information interchange – Representation of dates and

170 times

171 ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes

172 ISO 14971:— (ed 2), Medical devices – Application of risk management to medical devices

173 ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling and information to

174 be supplied –Part 1: General requirements

175 ISO 15459-2, Information technology – Automatic identification and data capture techniques – Unique

176 identification – Part 2: Registration procedures

177 ISO 15459-4, Information technology – Automatic identification and data capture techniques – Unique

178 identification – Part 4: Individual products and product packages

179 ISO 15459-6, Information technology – Automatic identification and data capture techniques – Unique

180 identification – Part 6: Groupings

181 ISO 16142-1:2016, Medical devices – Recognized essential principles of safety and performance of medical devices

182 – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices

183 and guidance on the selection of standards

184 ISO 16142-2:2017, Medical devices – Recognized essential principles of safety and performance of medical devices

185 – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and

186 guidance on the selection of standards

187 ISO 22742:2010, Packaging – Linear bar code and two-dimensional symbols for product packaging

188 IEC 60417 (database), Graphical symbols for use on equipment

189 IEC 62366-1:2015+AMD1:— , Medical devices – Part 1: Application of the usability engineering process to

190 medical devices
191 ISO 80000-1:2009, Quantities and units – Part 1: General
Under preparation. Stage at the time of publication: ISO FDIS 14971:2019.
Under preparation. Stage at the time of publication: IEC DAMD 62366-1:2019.
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192 3 Terms and definitions

193 For the purposes of this document, the terms and definitions given in ISO 7010:2011, ISO 13485:2016,

194 ISO 14971:—, ISO 16142-1:2016, ISO 16142-2:2017 and IEC 62366-1:2015+AMD1:— and the following

195 definitions apply.

196 NOTE An alphabetized index of defined terms used in this document is found beginning in Annex E.

197 3.1
198 accessory

199 item used together with one or more medical devices to enable or assist a medical device to be used in

200 accordance with its intended use

201 Note 1 to entry: Some authorities having jurisdiction consider an accessory to be a medical device.

202 3.2
203 accompanying information

204 information accompanying or on a medical device or accessory and containing information for the user or those

205 accountable for the installation, use, maintenance, decommissioning and disposal of the medical device or

206 accessory, particularly regarding safe use

207 Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.

208 Note 2 to entry: The accompanying information can consist of the instructions for use, technical description, installation

209 manual, quick reference guide, etc.

210 Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory,

211 visual, or tactile materials and multiple media types.
212 3.3
213 catalogue number
214 product code

215 letters, numbers or a combination of these assigned by a manufacturer for ordering one or more medical devices

216 or accessories
217 3.4
218 * clearly legible
219 easily legible
220 capable of being read by a person with normal vision
221 [SOURCE: IEC 60601-1:2005+AMD1:2012 [2], definition 3.15]
222 3.5
223 distributor

224 natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device

225 or accessory to the user

226 Note 1 to entry: More than one distributor may be involved in the supply chain.

227 Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and

228 transport on behalf of the manufacturer, importer or distributor, are not distributors.

229 [SOURCE: ISO 13485:2016 [14], definition 3.5, modified –added ‘or accessory’]

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230 3.7
231
e-documentation
232
electronic documentation

233 any form of electronically accessible information supplied by the manufacturer related to a medical device

234 EXAMPLE CD/DVD-ROM, Internet or other mode
235 Note 1 to entry: See Figure 1.
236
237 NOTE The label includes the packaging of the medical device.

238 Figure 1 – Relationship of terms used to describe information supplied by the manufacturer

239 3.8
240 expected lifetime
241 expected service life

242 time period specified by the manufacturer during which the medical device or accessory is expected to remain

243 safe for use
244 Note 1 to entry: The expected lifetime can be affected by the stability.

245 Note 2 to entry: Maintenance, repairs or upgrades (e.g. safety or cybersecurity modifications) can be necessary during the

246 expected lifetime.

247 [SOURCE: IEC 60601-1:2005+A1:2012, definition 3.28, modified –Added alternative term. The reference to

248 ‘me equipment or me system’ has been replaced with ‘medical device’, the parenthetical has been deleted and

249 the notes added.]
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250 3.9
251 importer

252 natural or legal person in the supply chain who is the first in a supply chain to make a medical device or

253 accessory, manufactured in another country or jurisdiction, available in the country or jurisdiction where it

254 is to be marketed

255 [SOURCE: ISO 13485:2016 [14], definition 3.7, modified –added ‘or accessory’]

256 3.10
257 information for safety

258 information provided to the user or responsible organization that is used as a risk control measure

259 EXAMPLE 1 Warnings, precautions or contraindications.

260 EXAMPLE 2 Instructions in the use of a medical device to prevent use error or avoid a hazardous situation.

261 EXAMPLE 3 Explanation of a safety feature of a medical device.

262 Note 1 to entry: Information for safety can be located on the display of a medical device.

263 3.11
264 information supplied by the manufacturer

265 all information related to the identification and use of a medical device or accessory, in whatever form provided,

266 intended to ensure the safe and effective use of the medical device or accessory

267 Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the

268 manufacturer.

269 Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from

270 information supplied by the manufacturer. However, some authorities having jurisdiction can consider such supplemental

271 information as information supplied by the manufacturer.
272 Note 3 to entry: See Figure 1.
273 3.12
274 instructions for use
275 IFU

276 portion of the accompanying information that is essential for the safe and effective use of a medical device or

277 accessory directed to the user of the medical device

278 Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant

279 spe
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