SIST EN ISO 20417:2026

SLOVENSKI STANDARD
01-junij-2026
Nadomešča:
SIST EN ISO 20417:2021
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO 20417:2026)
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2026)
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen
(ISO 20417:2026)
Dispositifs médicaux - Informations à fournir par le fabricant (ISO 20417:2026)
Ta slovenski standard je istoveten z: EN ISO 20417:2026
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
April 2026
ICS 11.040.01
Supersedes EN ISO 20417:2021
English version
Medical devices - Information to be supplied by the
manufacturer (ISO 20417:2026)
Dispositifs médicaux - Informations à fournir par le Medizinprodukte - Anforderungen an vom Hersteller
fabricant (ISO 20417:2026) bereitzustellende Informationen (ISO 20417:2026)
This European Standard was approved by CEN on 21 March 2026.

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, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2026 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 20417:2026 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 20417:2026) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for products with a health purpose including medical
devices" in collaboration with Technical Committee CEN-CENELEC/ 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 October 2026, and conflicting national standards shall
be withdrawn at the latest by October 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 20417:2021.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20417:2026 has been approved by CEN-CENELEC as EN ISO 20417:2026 without any
modification.
International
Standard
ISO 20417
Second edition
Medical devices — Information to
2026-03
be supplied by the manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
Reference number
ISO 20417:2026(en) © ISO 2026
ISO 20417:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 20417:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations .12
5 Information elements to be established .13
5.1 Units of measurement . 13
5.2 Graphical information . 13
5.3 Language and country identifiers .14
5.3.1 Language identifiers .14
5.3.2 Country identifiers .14
5.4 Dates .14
5.5 Full address .14
5.6 Model number . 15
5.7 Catalogue number . 15
5.8 Production control identifiers . 15
5.9 Unique device identifier . 15
5.10 Types of use/reuse .16
5.11 Sterile .16
6 Requirements for accompanying information .16
6.1 Requirements for information to be supplied on the label .16
6.1.1 Minimum requirements for the label .16
6.1.2 Identification of the manufacturer .17
6.1.3 Identification of the medical device or accessory .17
6.1.4 Other label requirements . 20
6.1.5 Consult instructions for use .21
6.1.6 Safety signs .21
6.2 Identification requirements for detachable components of a medical device or accessory . 22
6.3 Legibility of the label . 23
6.4 Durability of markings . 23
6.5 Information to be provided on the packaging . 23
6.5.1 General information . 23
6.5.2 Packaging for the lay user . 25
6.5.3 Special conditions indicated on the packaging . 25
6.5.4 Sterile packaging . 26
6.6 Requirements for information in the instructions for use and technical description .27
6.6.1 General .27
6.6.2 Requirements for instructions for use . 28
6.6.3 Additional requirements for the instructions for use for a lay user . 33
6.6.4 Requirements for technical description . 33
6.6.5 Requirements for e-documentation . 36
7 Other information that is required to be supplied with the medical device or accessory .36
7.1 Importer . 36
7.2 Distributor .37
7.3 Repackaging .37
7.4 Translation .37
7.5 Regulatory identification . 38
Annex A (informative) Particular guidance and rationale .39
Annex B (informative) Example test method for assessing clearly legible requirements . 41
Annex C (informative) Example test method for assessing durability .42

iii
ISO 20417:2026(en)
Annex D (informative) Reference to the IMDRF essential principles and labelling guidance .43
Annex E (informative) Alphabetized index of defined terms . 47
Bibliography .50

iv
ISO 20417:2026(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 products with a health purpose including medical devices, in collaboration with the
European Committee for Standardization (CEN) 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).
This second edition cancels and replaces the first edition (ISO 20417:2021), which has been technically
revised.
The main changes are as follows:
— update of the normative references;
— deletion of the former informative Annexes D, F, G and H;
— addition of the term ‘applicable policy’;
— deletion of item b) in Clause 4, and of item d) 1) in 6.1.2.
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.

v
ISO 20417:2026(en)
Introduction
This document provides general requirements for the identification and labelling of a medical device or
accessory that appears on the packaging, is marked on the medical device or accessory and is contained in
the 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 to simplify those documents. Additional specific product information requirements can be set
out in specific product standards or group standards. Unless specified otherwise within a product standard or
a group standard, the general requirements of this document apply.
This document has been prepared in consideration of:
— the application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices,
[24]
IMDRF/GRRP WG/N47:2024 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/
[25]
N52:2024 on the information supplied by the manufacturer of a medical device (see Annex D);
This document is organized in a structured manner. Clause 4 contains general process requirements.
Clause 5 contains the information that needs to be established to support creating the information supplied
by the manufacturer such as units of measurements, how to identify languages and countries and how to
express dates and addresses. It also contains the requirements regarding the identification of medical
devices and accessories, such as items like a catalogue number, unique identification of software version,
production control identifier, a consistent indication of use/reuse and sterilization state. Clause 6 contains
the requirements for the accompanying information of medical devices and accessories. This includes the
requirements for the packaging, the label and marking of medical devices and accessories, as well as the
instructions for use and technical description.
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
International Standard ISO 20417:2026(en)
Medical devices — Information to be supplied by the
manufacturer
1 Scope
NOTE 1 There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical
device or 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 code
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7010, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer —
Part 1: General requirements
ISO 15223-1:2021/Amd 1:2025, Medical devices — Symbols to be used with information to be supplied by
the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized
representative and modified EC REP symbols to not be country or region specific
IEC 60417, (database), Graphical symbols for use on equipment
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 14971:2019 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

ISO 20417:2026(en)
NOTE An alphabetized index of defined terms used in this document is found in Annex E.
3.1
accessory
item intended specifically by its manufacturer to be used together with one or more medical devices (3.23) 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: Some authorities having jurisdiction (3.4) consider an accessory to be a medical device.
Note 3 to entry: Some authorities having jurisdiction have a different definition of accessory.
Note 4 to entry: In general, spare parts are not considered accessories.
3.2
accompanying information
information supplied by the manufacturer (3.15) with or marked (3.22) on a medical device (3.23) or accessory
(3.1) for the user (3.49) or responsible organization (3.33), particularly regarding safe use
Note 1 to entry: The accompanying information is regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label (3.18), marking (3.22), instructions for use (3.16),
technical description (3.43), information shown on the packaging or graphical user interface (GUI), installation manual,
quick reference guide, etc. and can address the installation, use, processing (3.31), maintenance and disposal of the
medical device or accessory.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but can involve auditory,
visual, or tactile materials and multiple media types (e.g. CD-ROM, DVD-ROM, USB stick, website).
Note 4 to entry: Medical devices and accessories that can be used safely without accompanying information are exempted
from having accompanying information by some authorities having jurisdiction (3.4).
Note 5 to entry: See Figure 1.
NOTE 1 The label (3.18) can include the information on the packaging of the medical device (3.23) or accessory (3.1).
NOTE 2 e-documentation (3.9) can include any or all types of information supplied by the manufacturer partially or
entirely.
NOTE 3 ‘Marketing information’ is also known as ‘promotional material’.
Figure 1 — Relationship of terms used to describe information supplied by the manufacturer

ISO 20417:2026(en)
3.3
applicable policy
set of requirements relating to a product and its attributes such as form, fit, function, process or information
supplied by the manufacturer (3.15)
Note 1 to entry: The applicable policy is established by the authority having jurisdiction (3.4).
Note 2 to entry: The applicable policy can include specification for the format of the information to be supplied by the
manufacturer.
3.4
authority having jurisdiction
AHJ
regulatory authority
governmental agency or office assigned to oversee the regulation of a regulated product within a country,
jurisdiction or assigned territory
3.5
authorized representative
organization (3.28) established within a country or jurisdiction who has received a written mandate from
the manufacturer to act on their behalf for specified tasks regarding the latter’s obligations under that
country or jurisdiction’s legislation
[SOURCE: ISO 13485:2016, 3.2, modified — “natural or legal person” was changed to “organization”.]
3.6
catalogue number
commercial product name
commercial product code
reference number
reorder number
value given by the manufacturer to identify a specific medical device (3.23) or accessory (3.1) as it relates to
its form, fit, function and process
Note 1 to entry: A catalogue number can relate to manufacturing processes requiring differentiation for the end user
(3.49).
Note 2 to entry: A catalogue number only consists of letters or numbers or a combination of these.
Note 3 to entry: A commercial product code is different from the product coding of an authority having jurisdiction (3.4)
(e.g. US FDA ‘product code’ or procode classification).
Note 4 to entry: See Figure 2.
Note 5 to entry: Adapted from Reference [23].

ISO 20417:2026(en)
a
At least one of these conditional distinct product identifiers is required.
Figure 2 — Relationship of terms used to describe distinct product identification
3.7
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 in A.2.2.
[SOURCE: IEC 60601-1:2005, 3.15, modified — Note 1 to entry replaced.]
3.8
distributor
organization (3.28), different from the manufacturer or importer (3.13), in the supply chain who, on their
own behalf, furthers the availability of a product to the user (3.49)
Note 1 to entry: More than one distributor can be involved in the supply chain.
Note 2 to entry: Organizations 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: Repackaging or otherwise changing the container, wrapper, or accompanying information (3.2) of the
product package is not a distribution activity. Distributers can provide their identification on these items.
[SOURCE: ISO 13485:2016, 3.5, modified — In the definition, “different from the manufacturer or importer”
was added, “natural or legal person” was changed to “organization” and “medical device” was changed to
“product”; in Note 2 to entry “person” were changed to “organization”; Note 3 to entry was added.]
3.9
e-documentation
electronic documentation
form of electronically accessible information supplied by the manufacturer (3.15)
EXAMPLE 1 CD-ROM, DVD-ROM, USB stick, website or information accessible through an application programming
interface (API), in the case that software that does not have a graphical user (3.49) interface (GUI).
EXAMPLE 2 Machine readable information such as a software bill of materials (SBOM).
Note 1 to entry: See Figure 1.

ISO 20417:2026(en)
3.10
essential principles
essential principles of safety and performance
fundamental high-level requirements that, when conformed with, ensure a medical device (3.23) or accessory
(3.1) is safe and performs as intended
3.11
expected lifetime
expected service life
period specified by the manufacturer during which the product is expected to remain safe and effective for
use
Note 1 to entry: The expected lifetime can be affected by the stability (3.40).
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 products have an absolute expected lifetime (e.g. 5 y) and some have an expected lifetime based
on the number of uses or cycles (e.g. 15 uses) or duration of use, whereas other products (e.g. software) have a relative
expected lifetime (e.g. the time between two major releases).
Note 4 to entry: There is guidance or rationale for this definition in A.2.3.
Note 5 to entry: Adapted from IEC 60601-1:2005, 3.28.
3.12
group standard
basic standard that specifies safety and performance criteria applicable to several or a family of similar
products, processes, or services
Note 1 to entry: Group standards are sometimes referred to as semi-horizontal standards and usually apply to one field
(sector).
[SOURCE: ISO 16142-1:2016, 3.4]
3.13
importer
organization (3.28) who imports a product that was manufactured in one locale into another locale for the
purposes of marketing
3.14
information for safety
information provided to the user (3.49) or responsible organization (3.33) as a risk control measure
EXAMPLE 1 Warnings, precautions or contraindications.
EXAMPLE 2 Instructions for the use (3.16) of a medical device (3.23) or accessory (3.1) to prevent use error or avoid a
hazardous situation.
EXAMPLE 3 Explanation of a safety feature of a product.
Note 1 to entry: Information for safety can be included in any or all types of information supplied by the manufacturer
(3.15).
Note 2 to entry: Information for safety can be located on the display of a product.
3.15
information supplied by the manufacturer
information related to the identification and use of a medical device (3.23) 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: e-documentation (3.9) is included in the information supplied by the manufacturer.

ISO 20417:2026(en)
Note 2 to entry: Shipping documents (e.g. packing list and customs documents) and promotional material are excluded
from information supplied by the manufacturer. However, some authorities having jurisdiction (3.4) 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 or
accessory and its manufacturer, and provide essential information about its safety, performance, and appropriate use.
Note 4 to entry: See Figure 1.
3.16
instructions for use
IFU
package insert
portion of the accompanying information (3.2) that is
— directed to the user (3.49), and
— essential for the safe and effective use of a medical device (3.23) or accessory (3.1)
Note 1 to entry: A user can be either a lay (3.19) user or professional user with relevant specialized training.
Note 2 to entry: Instructions for the professional processing (3.31) 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 (3.4).
Note 5 to entry: See Figure 1.
3.17
IVD medical device
in vitro medical device
medical device (3.23), whether used alone or in combination, intended by the manufacturer for the in vitro
examination of specimens derived from the patient (3.29) solely or principally to provide information for
diagnostic, monitoring or compatibility purposes and including reagents, calibrators, control materials,
specimen receptacles, software, and related instruments or apparatus or other articles
[SOURCE: ISO 14971:2019, 3.7, modified — The term “in vitro diagnostic medical device” was changed to
“in vitro medical device”; in the definition, “device” was changed to “medical device” and “human body” to
“patient”.]
3.18
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: The word labelled is used to designate the corresponding act.
Note 2 to entry: Label includes the marking (3.22) on the medical device (3.23) or accessory (3.1).
Note 3 to entry: Information indicated on a graphical user (3.49) interface (GUI) is considered as appearing on the
item.
Note 4 to entry: See Figure 1.
Note 5 to entry: Adapted from Reference [25].

ISO 20417:2026(en)
3.19
lay, adj
lay person
not having formal education in a relevant field of healthcare or medical discipline and, if appropriate, not
having relevant specialized training on the use of the specific medical device (3.23)
EXAMPLE Lay user (3.49), lay responsible organization (3.33).
3.20
lot
batch
defined amount of material or a defined number of medical devices (3.23), 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 is manufactured under essentially the same conditions and is intended to have uniform
characteristics and quality within specified limits. A lot 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, are produced by the same person or with the same machine and 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.
3.21
lot number
lot code
batch code
batch number
production control identifier containing a combination of letters or numbers associated with a single lot
(3.20)
3.22
marking
information, in text or graphical format, durably affixed, printed, etched or attached by equivalent means to
a product
Note 1 to entry: The word marked is used to designate the corresponding act.
Note 2 to entry: 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.
Note 4 to entry: Adapted from ISO 18113-1:2022, 3.1.43.
3.23
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material
or other similar or related article, intended by the manufacturer to be used, alone or in combination, for
patients (3.29), for one or more of the specific medical purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,

ISO 20417:2026(en)
— providing information by means of in vitro examination of specimens derived from the patient,
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the patient, but which can be assisted in its intended function by such means
Note 1 to entry: Products which can be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances,
— aids for persons with disabilities,
— devices incorporating animal or human tissues,
— devices for in vitro fertilization or assisted reproductive technologies.
[SOURCE: ISO/IEC Guide 63:2019, 3.7, modified — “human being” and “human body” were changed to
“patient”.]
3.24
medical device family
group of medical devices (3.23) manufactured by or for the same organization (3.28) and having the same
basic design and performance characteristics related to safety, intended use and function
[SOURCE: ISO 13485:2016, 3.12]
3.25
model number
model
letters, numbers or a combination of these assigned by a manufacturer to distinguish, by function or type, a
particular medical device (3.23),accessory (3.1) or medical device family (3.24) from another
Note 1 to entry: See Figure 2.
3.26
multiple patient multiple use
intended by the manufacturer to be reused on multiple patients (3.29) for
multiple uses
Note 1 to entry: A multiple patient multiple use medical device (3.23) or accessory (3.1) typically requires processing
(3.31) between patients.
Note 2 to entry: A multiple patient multiple use medical device or accessory can require processing between uses on a
single patient.
3.27
normal use
operation, including stand-by, routine inspection and adjustments by any user (3.49), in accordance with
the accompanying information (3.2) or, for those products provided without accompanying information, with
generally accepted practice
Note 1 to entry: Normal use is different from intended use. While both include the concept of use as intended by
the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical
purpose, but maintenance, transport, processing (3.31), etc. as well.
Note 2 to entry: Use error can occur in normal use.
Note 3 to entry: Healthcare products that can be used safely without accompanying information are exempted from
having accompanying information by some authorities having jurisdiction (3.4).
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.9, modified — in the definition, “instructions for use” was
changed to “accompanying information”; in Note 3 to entry, “medical devices” was changed to “healthcare
products”.]
ISO 20417:2026(en)
3.28
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation, firm,
enterprise, authority, partnership, association, charity or institution, or part or combination thereof, whether
incorporated or not, public or private.
[SOURCE: ISO 9000:2015, 3.2.1, modified — Note 2 to entry was deleted.]
3.29
patient
subject of care
living being receiving healthcare services
Note 1 to entry: Living being means person or animal.
Note 2 to entry: Healthcare services include diagnostic, therapeutic, monitoring, surgical or dental procedures and can
be delivered in the home healthcare environment, professional healthcare environment, emergency medical services
environment or a special environment.
Note 3 to entry: A patient can be a user (3.49).
Note 4 to entry: Safety limit values can be different for different patients, especially for animal patients.
Note 5 to entry: Adapted from IEC 60601-1:2005, 3.76.
3.30
pictogram
simplified pictorial representation
Note 1 to entry: A pictogram is used to guide people and tell them how to achieve a certain goal.
3.31
processing
processes to prepare a new or used healthcare product for its intended
use
Note 1 to entry: Processing includes cleaning, disinfection and sterilization, as appropriate.
[SOURCE: ISO 17664-2:2021, 3.10, modified — “activity” was changed to “processes”; Note 1 to entry was
changed.]
3.32
product standard
standard that specifies necessary safety and performance requirements for a specific or a family of
product(s), process(es), or service(s) making reference, as far as possible, to basic standards and group
standards (3.12)
Note 1 to entry: Product standards are sometimes referred to as vertical standards.
3.33
responsible organization
organization (3.28) accountable for the installation, use, processing (3.31), maintenance, decommissioning
or disposal of a medical device (3.23), accessory (3.1) and their detachable parts
Note 1 to entry: The responsible organizati
...