ISO/FDIS 20417

Medical devices -- Information to be supplied by the manufacturer

Dispositifs médicaux -- Informations à fournir par le fabricant

Standards Content (sample)

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)
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© ISO 2020

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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

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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

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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.
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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.

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