EN ISO 20417:2021

SLOVENSKI STANDARD
01-julij-2021
Nadomešča:
SIST EN 1041:2008+A1:2013
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2021)
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Medizinprodukte - Anforderungen an allgemeine Informationen des Herstellers (ISO
20417:2021)
Dispositifs médicaux - Informations à fournir par le fabricant (ISO 20417:2021)
Ta slovenski standard je istoveten z: EN ISO 20417:2021
ICS:
01.110 Tehnična dokumentacija za Technical product
izdelke documentation
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 20417
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2021
ICS 11.040.01
Supersedes EN 1041:2008+A1:2013
English version
Medical devices - Information to be supplied by the
manufacturer (ISO 20417:2021)
Dispositifs médicaux - Informations à fournir par le Medizinprodukte - Anforderungen an allgemeine
fabricant (ISO 20417:2021) Informationen des Herstellers (ISO 20417:2021)
This European Standard was approved by CEN on 30 June 2020.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 20417:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 20417:2021) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2021, and conflicting national standards
shall be withdrawn at the latest by November 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1041:2008+A1:2013.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20417:2021 has been approved by CEN as EN ISO 20417:2021 without any modification.

INTERNATIONAL ISO
STANDARD 20417
First edition
2021-04
Medical devices — Information to be
supplied by the manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
Reference number
ISO 20417:2021(E)
©
ISO 2021
ISO 20417:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 20417:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General considerations . 9
5 Information elements to be established .10
5.1 Units of measurement . .10
5.2 Graphical information .10
5.3 Language and country identifiers .11
5.3.1 Language identifiers .11
5.3.2 Country identifiers .11
5.4 Dates .11
5.5 Full address .12
5.6 Commercial product name .12
5.7 Model number .12
5.8 Catalogue number .12
5.9 Production controls .12
5.10 Unique device identifier .13
5.11 Types of use/reuse .13
5.12 Sterile .13
6 Requirements for accompanying information .13
6.1 Requirements for information to be supplied on the label .13
6.1.1 Minimum requirements for the label . .13
6.1.2 Identification of the manufacturer .14
6.1.3 Identification of the medical device or accessory .15
6.1.4 Other label requirements .17
6.1.5 Consult instructions for use .18
6.1.6 Safety signs .19
6.2 Identification requirements for detachable components of a medical device or
accessory .20
6.3 Legibility of the label .20
6.4 Durability of markings .20
6.5 Information to be provided on the packaging.21
6.5.1 General information .21
6.5.2 Packaging for the lay user .22
6.5.3 Special conditions indicated on the packaging .23
6.6 Requirements for information in the instructions for use and technical description .24
6.6.1 General.24
6.6.2 Requirements for instructions for use .25
6.6.3 Additional requirements for the instructions for use for a lay user .30
6.6.4 Requirements for technical description .30
6.6.5 Requirements for e-documentation .33
7 Other information that is required to be supplied with the medical device or accessory .33
7.1 Importer .33
7.2 Distributor .33
7.3 Repackaging .34
7.4 Translation.34
7.5 Regulatory identification .35
Annex A (informative) Particular guidance and rationale .36
Annex B (informative) Example test method for assessing clearly legible requirements.39
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

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 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

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
1)
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 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

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 20417:2021(E)
a
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

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 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 education in a relevant field of healthcare or medical discipline
and, if appropriate, relevant specialized training on the use of the specific medical device
3.14
lot
batch
defined amount of material or a number of medical devices, including finished product and accessories
(3.1), that is manufactured in one process or a series of related processes and is intended to be
homogenous
Note 1 to entry: A lot or batch is manufactured under essentially the same conditions and is intended to have
uniform characteristics and quality within specified limits. A lot or batch is considered homogeneous when
equivalent parts or materials are manufactured or tested in the same manner, without interruption, typically on
the same day or in the same time period, and produced by the same person or with the same machine/equipment
set-up and fulfil the same quality specification.
Note 2 to entry: The defined amount of material or number of medical devices or accessories is normally associated
with a unique statement of conformity to a defined quality specification.
6 © ISO 2021 – All rights reserved

ISO 20417:2021(E)
3.15
lot number
batch code
batch number
lot code
production control containing a combination of letters or numbers associated with a single lot (3.14) or
batch (3.14)
3.16
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical
device or accessory (3.1)
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly
described in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of
marking.
Note 3 to entry: See Figure 1.
[8]
[SOURCE: ISO 18113-1:2009 , 2.4, modified — replaced ‘permanently’ with ‘durably’, deleted notes
and added Note 1 to entry and 'or accessory'.]
3.17
model number
model
letters, numbers or a combination of these assigned by a manufacturer to distinguish by function or
type, a particular medical device, accessory (3.1) or medical device family from another
Note 1 to entry: See Figure 2.
3.18
multiple patient multiple use
intended by the manufacturer to be reused on multiple patients for
multiple uses
Note 1 to entry: A multiple patient multiple use medical device or accessory typically requires processing between
patients.
Note 2 to entry: A multiple patient multiple use medical device or accessory may require processing between uses
on a single patient.
3.19
pictogram
simplified pictorial representation, used to guide people and tell them how to achieve a certain goal
[9]
[SOURCE: ISO/IEC TR 20007:2014 , 2.10]
3.20
processing
activity to prepare a new or used medical device or accessory
for its intended use
[10]
[SOURCE: ISO 11139:2018 , 3.214, modified — added ‘or, accessory’.]
3.21
safety sign
sign giving a general safety message, obtained by a combination of a colour and geometric shape and
which, by the addition of a graphical symbol, gives a particular safety message
[11]
[SOURCE: ISO 7010:2019 , 3.3]
ISO 20417:2021(E)
3.22
serial number
production control containing a combination of letters or numbers, selected by the manufacturer,
intended for quality control and identification purposes to uniquely distinguish an individual medical
device from other medical devices with the same catalogue number or model number
[12]
[SOURCE: ISO 14708-2:2012 , 3.20, modified — added ‘production control containing a’, replaced
‘and/or’ with ‘or’ and ‘to distinguish a device from other devices with the same model designation’ with
‘for quality control and identification purposes to distinguish an individual medical device from other
medical devices with the same catalogue number or model number’.]
3.23
service personnel
individuals or entity accountable to the responsible organization that install, assemble, maintain or
repair a medical device or accessory (3.1)
[2]
[SOURCE: IEC 60601-1:2005 , 3.113, modified — The reference to ‘me equipment, me systems or
equipment’ has been replaced by ‘a medical device or accessory’.]
3.24
shelf-life
period of time until the expiry date during which a medical device or accessory (3.1) in its original
packaging maintains its stability under the conditions specified in the information supplied by the
manufacturer
[4]
[SOURCE: IMDRF/GRRP WG/N52: 2019 , 3.36, modified — replaced ‘by the manufacturer’ with ‘in the
information supplied by the manufacturer’.]
3.25
single patient multiple use
intended by the manufacturer to be reused on an individual patient for
multiple uses
Note 1 to entry: A single patient multiple use medical device or accessory may require processing between uses.
Note 2 to entry: For an implantable medical device, the duration of a single use is from implanting to explanting
the medical device.
3.26
single use
do not re-use
use only once
intended by the manufacturer to be used on an individual patient or
specimen during a single procedure and then disposed of
Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further processed
and used again.
3.27
stability
ability to maintain safety and performance characteristics within the
specifications in information supplied by the manufacturer (3.10)
Note 1 to entry: Stability applies to:
— medical devices whose performance, physical, chemical or functional properties can be altered or compromised
over a stated time interval;
— the period of time over which sterility is assured;
— IVD reagents, calibrators and controls, when stored, transported and used in accordance with conditions
specified in the information supplied by the manufacturer
8 © ISO 2021 – All rights reserved

ISO 20417:2021(E)
— reconstituted lyophilized materials, working solutions and material removed from sealed containers, when
prepared, used and stored according to the information supplied by the manufacturer; and
— measuring instruments or measuring systems after calibration.
Note 2 to entry: Stability of an IVD reagent or measuring system is normally quantified with respect to time:
— in terms of the duration of a time interval over which a measured property changes by a stated amount; or
— in terms of the change of a property under specified conditions.
3.28
sterile
free from viable microorganisms
[10]
[SOURCE: ISO 11139:2018 , 3.271]
3.29
symbol
graphical representation appearing on the label and/or associated documentation of a medical device
that communicates characteristic information without the need for the supplier or receiver of the
information to have knowledge of the language of a particular nation or people
Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar
objects, including alphanumeric characters (with sufficient justification).
[SOURCE: ISO 15223-1:—, 3.20]
3.30
technical description
portion of the accompanying information directed to the responsible organization and service personnel
that is essential for preparation for the first use and safe use, maintenance or repair as well as processing,
transport or storage for the expected lifetime of a medical device
Note 1 to entry: The technical description may be included in the instructions for use.
Note 2 to entry: See Figure 1.
3.31
UDI carrier
unique device identification carrier
means to convey the UDI by using automatic identification and data capture (AIDC) and, if applicable,
its human readable interpretation (HRI)
Note 1 to entry: UDI carriers can include 1D/linear bar code, 2D/Matrix bar code, RFID, etc.
[13]
[SOURCE: MDRF/UDI WG/N7: 2013 ]
4 General considerations
a) The risk management process of ISO 14971:2019 and the usability engineering process of
IEC 62366-1:2015+AMD1: 2020 should be used to determine the information, including information
for safety, to be provided in the information supplied by the manufacturer.
NOTE Medical device-specific standards can require additional information supplied by the manufacturer.
b) Where this document specifies a specific edition of a normatively referenced document, the
manufacturer may substitute a more current version provided the manufacturer can demonstrate
that the residual risk that results from the substitution remains acceptable and is comparable to the
residual risk that results from applying the normatively referenced document.
ISO 20417:2021(E)
c) Information supplied by the manufacturer shall be in a language that is appropriate to the
intended user.
NOTE 1 The choice of language of the information supplied by the manufacturer can be required by the
authority having jurisdiction.
NOTE 2 More than one language can be required in some jurisdictions.
d) The accompanying information shall specify any:
1) special skills, special training and special knowledge required of the intended user or the
responsible organization that are necessary to be able to achieve the intended use of the medical
device; and
2) if applicable, restrictions on the use environment that the medical device is intended to be used.
e) The information supplied by the manufacturer shall be writt
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