Medical devices -- Information to be supplied by the manufacturer

NOTEÂ 1Â Â Â Â Â Â Â 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. NOTEÂ 2Â Â Â Â Â Â Â 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.

Dispositifs médicaux -- Informations à fournir par le fabricant

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.

General Information

Status
Published
Publication Date
12-Apr-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
30-May-2020
Completion Date
29-May-2020
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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
---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
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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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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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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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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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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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
---------------------- Page: 8 ----------------------
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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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 behalf of the manufacturer, importer or distributor, are not distributors.

Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container,

wrapper, or accompanying information of the medical device or medical device package other than providing the

identification of the distributor.
[7]

[SOURCE: ISO 13485:2016, 3.5 , modified — added ‘or accessory’ and Note 3 to entry.]

3.6
e-documentation
electronic documentation

any form of electronically accessible information supplied by the manufacturer (3.10) related to a medical

device or accessory (3.1)
EXAMPLE CD/DVD-ROM, USB stick, website.
Note 1 to entry: See Figure 1.
4 © ISO 2021 – All rights reserved
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ISO 20417:2021(E)
3.7
expected lifetime
expected service life

time period specified by the manufacturer during which the medical device or accessory (3.1) is expected

to remain safe and effective for use
Note 1 to entry: The expected lifetime can be affected by the stability.

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

during the expected lifetime.

Note 3 to entry: Some medical devices have an absolute lifetime (e.g., 5 y), whereas other medical devices (e.g.,

software) have a relative lifetime (e.g., the time between two major releases).

Note 4 to entry: There is guidance or rationale for this definition contained in Clause A.2.

[2]

[SOURCE: IEC 60601-1:2005+AMD1: 2012 , 3.28, modified — added alternative term. The reference

to ‘me equipment or me system’ has been replaced with ‘medical device’, the parenthetical has been

deleted and the notes added.]
3.8
importer

natural or legal person who imports a medical device or accessory (3.1) into a locale that was

manufactured in another locale for the purposes of marketing
3.9
information for safety

information provided to the user or responsible organization as a risk control measure

EXAMPLE 1 Warnings, precautions or contraindications.

EXAMPLE 2 Instructions for the use of a medical device or accessory to prevent use error or avoid a hazardous

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

Note 1 to entry: Information for safety may be found in any or all types of information supplied by the manufacturer.

Note 2 to entry: Information for safety can be located on the display of a medical device.

3.10
information supplied by the manufacturer

information related to the identification and use of a medical device or accessory (3.1), in whatever form

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

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

manufacturer.

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

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

supplemental information as information supplied by the manufacturer.

Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device

and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the

user or other relevant persons.
Note 4 to entry: See Figure 1.
© ISO 2021 – All rights reserved 5
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ISO 20417:2021(E)
3.11
instructions for use
IFU
package insert

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

device or accessory (3.1) directed to the user of the medical device

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

relevant specialized training.

Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a

medical device or accessory can be included in the instructions for use.

Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or

accessory.

Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use

are exempted from having instructions for use by some authorities having jurisdiction.

Note 5 to entry: See Figure 1.
3.12
label

written, printed, or graphic information appearing on the item itself, on the

packaging of each item or on the packaging of multiple items

Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act.

Note 2 to entry: Label includes the marking on the medical device or accessory.

Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is

considered as appearing on the item.
Note 4 to entry: See Figure 1.
[4]

[SOURCE: IMDRF/GRRP WG/N52: 2019 , 3.17, modified –added notes and replaced ‘unit’ and ‘devices’

with ‘item’.]
3.13
lay
lay person
individual who does not have formal educat
...

NORME ISO
INTERNATIONALE 20417
Première édition
2021-04
Dispositifs médicaux — Informations
à fournir par le fabricant
Medical devices — Information to be supplied by the manufacturer
Numéro de référence
ISO 20417:2021(F)
ISO 2021
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ISO 20417:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 20417:2021(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 2

4 Considérations générales ............................................................................................................................................................................ 9

5 Éléments informatifs à définir ............................................................................................................................................................10

5.1 Unités de mesure ................................................................................................................................................................................10

5.2 Informations graphiques .............................................................................................................................................................10

5.3 Identifiants de langue et de pays ..........................................................................................................................................11

5.3.1 Identifiants de langue ...............................................................................................................................................11

5.3.2 Identifiants de pays ....................................................................................................................................................11

5.4 Dates .............................................................................................................................................................................................................12

5.5 Adresse complète ...............................................................................................................................................................................12

5.6 Nom commercial du produit ................................................................................................................................................12

5.7 Numéro du modèle ........................................................................................................................................................................12

5.8 Référence catalogue ....................................................................................................................................................................12

5.9 Contrôles de la production ........................................................................................................................................................13

5.10 Identifiant unique du dispositif .............................................................................................................................................13

5.11 Types d’utilisation/de réutilisation ...................................................................................................................................13

5.12 Stérile .........................................................................................................................................................................................................13

6 Exigences relatives aux informations d’accompagnement ....................................................................................14

6.1 Exigences relatives aux informations requises sur l’étiquette .................................................................14

6.1.1 Exigences minimales concernant l’étiquette .....................................................................................14

6.1.2 Identification du fabricant ................................................................................................................................14

6.1.3 Identification du dispositif médical ou de l’accessoire ...........................................................15

6.1.4 Autres exigences concernant l’étiquette ................................................................................................18

6.1.5 Consultation des instructions d’utilisation .......................................................................................19

6.1.6 Signaux de sécurité .................................................................................................................................................19

6.2 Exigences en matière d’identification des composants détachables d’un dispositif

médical ou d’un accessoire ....................................................................................................................................................20

6.3 Lisibilité de l’étiquette ................................................................................................................................................................21

6.4 Durabilité des marquages .......................................................................................................................................................21

6.5 Informations à fournir sur l’emballage ...........................................................................................................................22

6.5.1 Généralités .........................................................................................................................................................................22

6.5.2 Emballage pour un utilisateur profane .................................................................................................23

6.5.3 Conditions particulières indiquées sur l’emballage .......................................................................24

6.6 Exigences relatives aux informations présentes dans les instructions d’utilisation

et la description technique ....................................................................................................................................................25

6.6.1 Généralités .........................................................................................................................................................................26

6.6.2 Exigences relatives aux instructions d’utilisation .......................................................................27

6.6.3 Exigences supplémentaires relatives aux instructions d’utilisation pour

un utilisateur profane ..........................................................................................................................................31

6.6.4 Exigences relatives à la description technique ...............................................................................32

6.6.5 Exigences relatives à la documentation électronique ..............................................................34

7 Autres informations devant être fournies avec le dispositif médical ou l’accessoire ................35

7.1 Importateur .........................................................................................................................................................................................35

7.2 Distributeur .........................................................................................................................................................................................35

7.3 Reconditionnement..........................................................................................................................................................................36

7.4 Traduction ................................................................................................................................................................................................36

7.5 Identification réglementaire ....................................................................................................................................................36

© ISO 2021 – Tous droits réservés iii
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ISO 20417:2021(F)

Annexe A (informative) Recommandations et justifications particulières ...............................................................38

Annexe B (informative) Exemple de méthode d’essai pour évaluer des exigences clairement

lisibles ...........................................................................................................................................................................................................................41

Annexe C (informative) Exemple de méthode d’essai pour évaluer la durabilité ..............................................42

Annexe D (informative) Référence croisée entre le document et les exigences prises en compte ...43

Annexe E (informative) Référence aux principes essentiels de l’IMDRF et

aux recommandations pour l’étiquetage .................................................................................................................................55

Annexe F (informative) Référence aux principes essentiels .......................................................................................................59

Annexe G (informative) Référence aux exigences en matière de sécurité et de performance

pour les dispositifs médicaux ................................................................................................................................................................63

Annexe H (informative) Référence aux exigences en matière de sécurité et de performance

pour les dispositifs médicaux de DIV .............................................................................................................................................67

Annexe I (informative) Terminologie — Index alphabétique des termes définis ..............................................71

Bibliographie ...........................................................................................................................................................................................................................73

iv © ISO 2021 – Tous droits réservés
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ISO 20417:2021(F)
Avant-propos

L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes

nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est

en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.

L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d’approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de

droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de

brevets reçues par l’ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion

de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ fr/ avant-propos.

Le présent document a été élaboré par le comité technique ISO/TC 210, Management de la qualité et

aspects généraux correspondants des dispositifs médicaux, en collaboration avec le comité technique

CEN/CLC JTC 3 Gestion de la qualité et aspects généraux correspondants pour les dispositifs médicaux, du

Comité européen de normalisation (CEN) conformément à l’Accord de coopération technique entre l’ISO

et le CEN (Accord de Vienne).

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
© ISO 2021 – Tous droits réservés v
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ISO 20417:2021(F)
Introduction

Le présent document spécifie les exigences concernant l’identification et l’étiquetage d’un dispositif

médical ou d’un accessoire, leur emballage, le marquage d’un dispositif médical ou d’un accessoire et les

informations d’accompagnement. L’objectif du présent document est de servir de source centrale pour

ces exigences génériques communes, en permettant à chaque norme de produit spécifique ou norme de

groupe de se concentrer de manière plus précise sur les exigences uniques applicables à un dispositif

médical spécifique ou à un ensemble de dispositifs médicaux.

Les exigences d’une norme de produit relative à un dispositif médical ou à un ensemble peuvent s’appuyer

sur ces exigences générales. En cas de conflit et s’il existe une norme de produit ou une norme de groupe,

il convient de ne pas utiliser séparément le présent document. Les exigences spécifiques des normes de

produit relatives à un dispositif médical ou des normes de groupe prévalent sur les exigences du présent

document. Sauf spécification contraire dans une norme de produit ou une norme de groupe, les exigences

générales du présent document s’appliquent.

Certaines autorités compétentes imposent des exigences qui peuvent différer de celles du présent

document.
Le présent document a été élaboré en considérant:

— l’application du document Essential Principles of Safety and Performance of Medical Devices and IVD

[3]

Medical Devices, IMDRF/GRRP WG/N47: 2018 dans les informations fournies par le fabricant d’un

dispositif médical (voir Annexe D);

— l’application du document Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/

[4]

GRRP WG/ N52: 2019 dans les informations fournies par le fabricant d’un dispositif médical (voir

Annexe D);

— l’application des principes essentiels de sécurité et de performance dans les informations fournies par

le fabricant d’un dispositif médical conformément à l’ISO 16142-1:2016 (voir Annexe E);

— l’application des principes essentiels de sécurité et de performance dans les informations fournies par

le fabricant d’un dispositif médical de DIV conformément à l’ISO 16142-2:2017 (voir Annexe F);

— les exigences générales en matière de sécurité et de performance pour les informations fournies par

[5]

le fabricant d’un dispositif médical conformément au Règlement (UE) 2017/745 (voir Annexe G);

— les exigences générales en matière de sécurité et de performance pour les informations fournies par

[6]

le fabricant d’un dispositif médical conformément au Règlement (UE) 2017/746 (voir Annexe H).

Les caractéristiques typographiques suivantes sont utilisées tout au long du présent document:

— exigences et définitions: caractères romains;

— informations apparaissant en dehors des tableaux, telles que les notes, exemples et références:

caractères de taille réduite; texte normatif des tableaux: caractères de taille réduite;

— spécifications de conformité et termes définis dans l’Article 3 du présent document ou en note: caractères

italiques.

Dans le présent document, le «ou» conjonctif doit être interprété comme un «ou inclusif» de sorte

qu’une instruction est vraie si toute combinaison des conditions l’est également.

Dans le présent document, les formes verbales suivantes sont utilisées:
— «doit» implique une exigence;
— «il convient de/que» indique une recommandation;
— «peut/il est admis» indique une autorisation;
vi © ISO 2021 – Tous droits réservés
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ISO 20417:2021(F)
— «peut/il est possible» indique une possibilité ou une capacité;

Les exigences du présent document sont décomposées de sorte que chaque exigence soit définie

individuellement. Cette méthode vise à aider le suivi automatique des exigences.
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NORME INTERNATIONALE ISO 20417:2021(F)
Dispositifs médicaux — Informations à fournir par le
fabricant
1 Domaine d’application

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.
2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s’applique (y compris les

éventuels amendements).

ISO 3166-1, Codes pour la représentation des noms de pays et de leurs subdivisions — Partie 1: Codes de pays

ISO 3864-1:2011, Symboles graphiques — Couleurs de sécurité et signaux de sécurité — Partie 1: Principes

de conception pour les signaux de sécurité et les marquages de sécurité
ISO 7000, Symboles graphiques utilisables sur le matériel — Symboles enregistrés

ISO 7010:2019, Symboles graphiques — Couleurs de sécurité et signaux de sécurité — Signaux de sécurité

enregistrés

ISO 8601-1, Date et heure — Représentations pour l'échange d'information — Partie 1: Règles de base

ISO 13485:2016, Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins

réglementaires

ISO 14971:2019, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux

ISO 15223-1:— , Dispositifs médicaux — Symboles à utiliser avec les étiquettes, l’étiquetage et les

informations à fournir relatifs aux dispositifs médicaux — Partie 1: Exigences générales

ISO 16142-1:2016, Dispositifs médicaux — Lignes directrices pour le choix des normes correspondant aux

principes essentiels reconnus de sécurité et de performance des dispositifs médicaux — Partie 1: Principes

essentiels généraux et principes essentiels spécifiques supplémentaires pour tous les dispositifs médicaux

non DIV et directives sur le choix des normes

ISO 16142-2:2017, Dispositifs médicaux — Principes essentiels reconnus de sécurité et de performance

des dispositifs médicaux — Partie 2: Principes essentiels généraux et principes essentiels spécifiques

supplémentaires pour tous les dispositifs médicaux de DIV et directives sur le choix des normes

1) En cours d’élaboration. Stade au moment de la publication: ISO/FDIS 15223-1:2021.

© ISO 2021 – Tous droits réservés 1
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ISO 20417:2021(F)
IEC 60417, (database), Graphical symbols for use on equipment

I EC 6236 6 -1:2015/A 1: 2019, Dispositifs médicaux — Partie 1: Application de l'ingénierie de l'aptitude à

l'utilisation aux dispositifs médicaux
ISO 80000-1, Grandeurs et unités — Partie 1: Généralités
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions de l’ISO 13485:2016, l’ISO 14971:2019,

l’ISO 16142-1:2016, l’ISO 16142-2:2017 et l’IEC 62366-1:2015+AMD1: 2020 comme spécifié dans

l’Annexe I, ainsi que les définitions suivantes s’appliquent. L’ISO et l’IEC tiennent à jour des bases de

données terminologiques destinées à être utilisées en normalisation, consultables aux adresses

suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/ .

NOTE L’Annexe I fournit un index alphabétique des termes employés dans le présent document.

3.1
accessoire

article désigné explicitement par son fabricant pour être utilisé conjointement avec un ou plusieurs

dispositifs médicaux pour permettre spécifiquement ou aider à l’utilisation de ces dispositifs médicaux

conformément à leur utilisation prévue

Note 1 à l'article: Un accessoire est généralement un consommable ou un article séparé prévu pour une utilisation

en association avec un ou plusieurs dispositifs médicaux.

Note 2 à l'article: Note 2 à l’article: Certaines autorités compétentes considèrent qu’un accessoire est un dispositif

médical.

Note 3 à l'article: Certaines autorités compétentes ont une définition différente du terme accessoire.

3.2
informations d’accompagnement

informations accompagnant ou marquées sur un dispositif médical ou un accessoire (3.1) à destination

de l’utilisateur ou des personnes responsables de l’installation, de l’utilisation, du traitement, de la

maintenance, de la mise en service et de la mise au rebut du dispositif médical ou de l’accessoire, en

particulier concernant une utilisation sûre

Note 1 à l'article: Les informations d’accompagnement doivent être considérées comme faisant partie intégrante

du dispositif médical ou de l’accessoire.

Note 2 à l'article: Les informations d’accompagnement peuvent consister en une étiquette, un marquage, des

instructions d’utilisation, une description technique, un manuel d’installation, un guide de référence rapide, etc.

Note 3 à l'article: Les informations d’accompagnement ne sont pas nécessairement écrites ou imprimées, mais

peuvent comprendre des supports sonores, visuels ou tactiles et des médias multiples (par exemple: CD/DVD-

ROM, clé USB, site Internet).
Note 4 à l'article: Voir la Figure 1.
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ISO 20417:2021(F)

Note 5 à l’article L’étiquette peut contenir les informations sur l’emballage du dispositif médical.

Note 6 à l’article La documentation électronique peut contenir un ou tous les types d’informations fournies par le

fabricant, partiellement ou totalement.

Note 7 à l’article Les informations marketing sont également appelées matériel promotionnel.

Figure 1 — Relations entre les termes utilisés pour décrire les informations fournies par

le fabricant
3.3
référence catalogue
nom commercial du produit
code commercial du produit

valeur donnée par le fabricant pour l’identification d’un dispositif médical ou d’un accessoire (3.1)

spécifique se rapportant à sa forme/son ajustement, sa fonction et son traitement (c’est-à-dire les

traitements de fabrication qui nécessite une différenciation pour l’utilisateur final)

Note 1 à l'article: Une référence catalogue doit se composer de lettres ou de numéros.

Note 2 à l'article: Pour les besoins du présent document, il convient de ne pas confondre le code commercial du

produit avec le «code de produit» de la FDA ou la classification par procode.

Note 3 à l'article: Les synonymes du numéro de catalogue sont «numéro de référence» ou «numéro de commande».

Note 4 à l'article: Voir la Figure 2.

[SOURCE: IMDRF/GRRP WG/52:2019, 3.2, modifiée — «ou un accessoire» ainsi que des Notes à l’article

ont été ajoutés.]
3.4
clairement lisible
facilement lisible

qui peut être lu par une personne ayant une vision normaleNote 1 à l’article: Il y a des indications ou

une justification pour cet Article figurant dans l'Article A.2.

[SOURCE: IEC 60601-1:2005/A1: 2012, 3.15, modifiée — Note 1 à l’article ont été ajoutée.]

© ISO 2021 – Tous droits réservés 3
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ISO 20417:2021(F)
Au moins un de ces identifiants conditionnels distincts est requis.

Figure 2 — Relation entre les termes utilisés pour décrire l’identification de produit distincte

3.5
distributeur

personne physique ou morale, différente du fabricant ou de l’importateur, dans la chaîne

d’approvisionnement qui, en son nom propre, contribue à la disponibilité d’un dispositif médical ou d’un

accessoire (3.1)pour l’utilisateur

Note 1 à l'article: Plusieurs distributeurs peuvent être impliqués dans la chaîne d’approvisionnement.

Note 2 à l'article: Pour les besoins du présent document, les personnes de la chaîne d’approvisionnement

impliquées dans les activités telles que le stockage et le transport au nom du fabricant, de l’importateur ou du

distributeur, ne sont pas des distributeurs.

Note 3 à l'article: Les activités de distribution à elles seules ne comprennent pas le reconditionnement ou tout

changement de conteneur, d’enveloppe ou d’informations d’accompagnement du dispositif médical ou d’emballage

d’un dispositif médical autres que pour fournir l’identification du distributeur.

[SOURCE: ISO 13485:2016, 3.5, modifiée — «ou d’un accessoire» ainsi que la Note 3 ont été ajoutés.]

3.6
e-documentation
documentation électronique

toute forme d’informations fournies par le fabricant (3.10) accessibles par voie électronique et se

rapportant à un dispositif médical ou un accessoire (3.1)
EXEMPLE CD/DVD-ROM, clé USB, site Internet.
Note 1 à l'article: Voir la Figure 1.
3.7
durée de vie prévue
durée de vie escomptée

période spécifiée par le fabricant durant laquelle le dispositif médical ou l’accessoire (3.1) est censé rester

d’utilisation sûre et efficace
Note 1 à l'article: La durée de vie prévue peut être affectée par la stabilité.
4 © ISO 2021 – Tous droits réservés
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ISO 20417:2021(F)

Note 2 à l'article: Une maintenance, des réparations ou des mises à niveau (par exemple des modifications liées à

la sécurité ou à la cybersécurité) peuvent être nécessaires pendant la durée de vie prévue.

Note 3 à l'article: Certains dispositifs médicaux disposent d’une durée de vie absolue (par exemple, 5 ans), tandis

que d’autres dispositifs médicaux (par exemple, un logiciel) disposent d’une durée de vie relative (par exemple,

l’intervalle de temps entre deux mises à jour importantes).

Note 4 à l'article: Il y a des indications ou une justification pour cet Article figurant dans l'Article A.2.

[2]

[SOURCE: IEC 60601-1:2005+AMD1: 2012 , 3.28, modifiée — Un terme synonyme a été ajouté. La

référence à l’«appareil EM» ou au «système EM» a été remplacée par «dispositif médical», la parenthèse a

été supprimée et les notes ajoutées.]
3.8
importateur

personne physique ou morale qui importe dans un lieu un dispositif médical ou un accessoire (3.1) qui a

été fabriqué au sein d’un autre lieu à des fins de commercialisation
3.9
informations de sécurité
informations fournies à l’utilisateur ou à l’organisme responsable comme une me
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 20417
ISO/TC 210
Medical devices — Information to be
Secretariat: ANSI
supplied by the manufacturer
Voting begins on:
2020­04­03
Voting terminates on:
2020­05­29
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 20417:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
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ISO/FDIS 20417:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
CH­1214 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 2020 – All rights reserved
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ISO/FDIS 20417:2020(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 .............................................................................................................................................................................................11

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 ....................................................................14

6.1.4 Other label requirements .....................................................................................................................................17

6.1.5 * Consult instructions for use .........................................................................................................................18

6.1.6 Safety signs .....................................................................................................................................................................18

6.2 Identification requirements for detachable components of a medical device or

accessory ................................................................................................................................................................................................19

6.3 Legibility of the label ....................................................................................................................................................................20

6.4 Durability of markings ...............................................................................................................................................................20

6.5 Information to be provided on the packaging...........................................................................................................20

6.5.1 General information ...................................................................................................................................................20

6.5.2 * Packaging for the lay user ...............................................................................................................................22

6.5.3 Special conditions indicated on the packaging ...................................................................................22

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 ............................29

6.6.4 * Requirements for technical description ...........................................................................................30

6.6.5 Requirements for e-documentation ..........................................................................................................32

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 ...........................................................................................................................................................................................33

7.4 Translation...............................................................................................................................................................................................34

7.5 Regulatory identification ............................................................................................................................................................34

Annex A (informative) Particular guidance and rationale ..........................................................................................................35

Annex B (informative) Example test method for assessing clearly legible ................................................................38

© ISO 2020 – All rights reserved iii
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ISO/FDIS 20417:2020(E)

Annex C (informative) Example test method for assessing durability ...........................................................................39

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

considered ................................................................................................................................................................................................................40

Annex E (informative) Reference to the IMDRF essential principles and labelling guidances ...............52

Annex F (informative) Reference to the essential principles ....................................................................................................56

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

medical devices ....................................................................................................................................................................................................60

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

IVD medical devices .........................................................................................................................................................................................64

Annex I (informative) Terminology — Alphabetized index of defined terms .........................................................68

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

iv © ISO 2020 – All rights reserved
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ISO/FDIS 20417:2020(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 non­governmental, 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.

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 2020 – All rights reserved v
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ISO/FDIS 20417:2020(E)
Introduction

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

accessory, their 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 D);

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

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

— 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 16142­2:2017 (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 following print types are used:
— Requirements and definitions: roman type.

— Informative material appearing outside of tables, such as notes, examples and references: in smaller

type. Normative text of tables is also in a smaller type.

— Conformance specifications and terms defined in Clause 3 of this document or as noted: italic type.

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.

The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2. For

the purposes of this document, the auxiliary verb:

— “shall” means that conformance with a requirement or a test is mandatory for conformance with

this document;

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

for conformance with this document;

— “may” is used to describe permission (e.g., a permissible way to achieve conformance with a

requirement or test);
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ISO/FDIS 20417:2020(E)
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.

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

This is done to support automated requirements tracking.

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

that there is guidance or rationale related to that item in Annex A.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 20417:2020(E)
Medical devices — Information to be supplied by the
manufacturer
1 * Scope

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, their 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 Some authorities with 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 3166­1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes

ISO 3864­1:2011, 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 8601­1, 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 15223­1 , Medical devices — Symbols to be used with medical device labels, labelling and information

to be supplied — Part 1: General requirements

ISO 16142­1:2016, 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 16142­2:2017, 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

I EC 6236 6 ­1:2015+A M D1: 2019, Medical devices — Part 1: Application of the usability engineering process

to medical devices
ISO 80000­1, Quantities and units — Part 1: General
1) Under preparation. Stage at the time of publication: ISO/DIS 15223­1:2020.
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ISO/FDIS 20417:2020(E)

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

extent (in whole or in part) to which they apply.
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 7010:2019, ISO 13485:2016,

ISO 14971:2019, ISO 15223­1, ISO 16142­1:2016, ISO 16142­2:2017 and IEC 62366­1:2015+AMD1: 2019 as

specified in Annex E 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 beginning 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.
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ISO/FDIS 20417:2020(E)

NOTE 1 The label can include the information on the packaging of the medical device.

NOTE 2 e-documentation may include any or all types of information supplied by the manufacturer partially or

entirely.

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.

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: See Figure 2.

[SOURCE: IMDRF/GRRP WG/52:2019, definition 3.2, modified — added ‘or accessory’ and Notes to entry.]

3.4
* clearly legible
easily legible
capable of being read by a person with normal vision
[SOURCE: IEC 60601­1:2005+AMD1: 2012, 3.15]
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ISO/FDIS 20417:2020(E)
At least one of these conditional distinct product identifiers is required.

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

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

Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container,

wrapper, or accompanying information of the medical device or medical device package other than providing the

identification of the distributor.
[SOURCE: ISO 13485:2016, 3.5, modified — added ‘or accessory’ and note 3.]
3.6
e-documentation
electronic documentation

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

or accessory (3.1)
EXAMPLE CD/DVD­ROM, USB stick, website.
Note 1 to entry: See Figure 1.
3.7
* expected lifetime
expected service life

time period specified by the manufacturer during which the medical device or accessory (3.1) is expected

to remain safe and effective for use
Note 1 to entry: The expected lifetime can be affected by the stability.
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ISO/FDIS 20417:2020(E)

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

during the expected lifetime.

Note 3 to entry: Some medical devices have an absolute lifetime (e.g., 5 y), whereas other medical devices (e.g.,

software) have a relative lifetime (e.g., the time between two major releases).

[SOURCE: IEC 60601-1:2005+A1: 2012, 3.28, modified — added alternative term. The reference to

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

and the notes added.]
3.8
importer

natural or legal person who imports a medical device or accessory (3.1) into a locale that was

manufactured in another locale for the purposes of marketing
3.9
information for safety

information provided to the user or responsible organization as a risk control measure

EXAMPLE 1 Warnings, precautions or contraindications.

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

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

Note 1 to entry: Information for safety may be found in any or all types of information supplied by the

manufacturer.

Note 2 to entry: Information for safety can be located on the display of a medical device.

3.10
information supplied by the manufacturer

all information related to the identification and use of a medical device or accessory (3.1), in whatever

form provided, intended to ensure the safe and effective use of the medical device or accessory

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

manufacturer.

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

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

supplemental information as information supplied by the manufacturer.

Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device

and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the

user or other relevant persons.
Note 4 to entry: See Figure 1.
3.11
instructions for use
IFU
package insert

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

device or accessory (3.1) directed to the user of the medical device

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

relevant specialized training.

Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a

medical device or accessory can be included in the instructions for use.

Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device.

© ISO 2020 –
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