prEN ISO 20417

SLOVENSKI STANDARD
01-januar-2025
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO/DIS
20417:2024)
Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen
(ISO/DIS 20417:2024)
Dispositifs médicaux - Informations à fournir par le fabricant (ISO/DIS 20417:2024)
Ta slovenski standard je istoveten z: prEN ISO 20417
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.

DRAFT
International
Standard
ISO/DIS 20417
ISO/TC 210
Medical devices — Information to
Secretariat: ANSI
be supplied by the manufacturer
Voting begins on:
Dispositifs médicaux — Informations à fournir par le fabricant
2024-11-29
ICS: 11.040.01
Voting terminates on:
2025-02-21
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 20417:2024(en)
ISO/DIS 20417:2024(en)
© ISO 2024
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
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DIS 20417:2024(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 . 15
5.6 Commercial product name . 15
5.7 Model number . 15
5.8 Catalogue number . 15
5.9 Production controls . 15
5.10 Unique device identifier .16
5.11 Types of use/reuse .16
5.12 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
6.6 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 .32
6.6.4 Requirements for technical description . 33
6.6.5 Requirements for e-documentation . 35
7 Other information that is required to be supplied with the medical device or accessory .36
7.1 Importer . 36
7.2 Distributor . 36
7.3 Repackaging . 36
7.4 Translation .37
7.5 Regulatory identification .37
Annex A (informative) Particular guidance and rationale .38
Annex B (informative) Example test method for assessing clearly legible requirements . 41
Annex C (informative) Example test method for assessing durability .42

iii
ISO/DIS 20417:2024(en)
Annex D (informative) Reference to the IMDRF essential principles and labelling guidances .43
Annex E (informative) Terminology — Alphabetized index of defined terms . 47
Annex ZA  Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .49
Annex ZB (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .58
Bibliography .65

iv
ISO/DIS 20417:2024(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).
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.
This second edition cancels and replaces the first edition (ISO 20417:2021), which has been technically
revised.
The main change are as follows:
— updated the normative references;
— deletion of informative Annexes D, F, G and H;
— addition of the concept of applicable policy; and
— deletion of 4 b) and 6.1.2.d) 1).

v
ISO/DIS 20417:2024(en)
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 Devices,
[21]
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/
[22]
N52:2019 on the information supplied by the manufacturer of a medical device (see Annex D);
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
DRAFT International Standard ISO/DIS 20417:2024(en)
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 code
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 14971:2019, Medical devices — Application of risk management to medical devices
1)
ISO 15223-1:2021+AMD1 , Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
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 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 https:// www .electropedia .org/
NOTE An alphabetized index of defined terms used in this document is found in Annex E.
1) Under preparation. Stage at the time of publication: ISO/DAMD1 ISO 15223-1:2024.

ISO/DIS 20417:2024(en)
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 (3.4) 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) accompanying or marked (3.22) on a medical device (3.23) or
accessory (3.1) for the user (3.50) or those accountable for the installation, use, processing (3.31), 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 (3.18), marking (3.22), instructions for use
(3.16), technical description (3.43), installation manual, quick reference guide, etc. and can address the installation,
use, processing (3.31), maintenance, decommissioning and disposal of the medical device or accessory
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.
NOTE 1 The label (3.18) can include the information on the packaging of the medical device (3.23).
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/DIS 20417:2024(en)
3.3
applicable policy
set of requirements relating to the medical device (3.23) or accessory (3.1) and its attributes such as form, fit,
function, process or information to be supplied by the manufacturer (3.15)
Note 1 to entry: The applicable policy shall be established by the authority having jurisdiction (3.4).
Note 2 to entry: The applicable policy may include specification for the format of the information to be supplied by the
manufacturer.
3.4
authority having jurisdiction
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
natural or legal person established within a country or jurisdiction who has received a written mandate
from the manufacturer to act on his behalf for specified tasks regarding the latter’s obligations under that
country or jurisdiction’s legislation
[SOURCE: ISO 13485:2016, 3.2, modified — replaced “with regard to” with “regarding”.]
3.6
catalogue number
commercial product name
commercial product code
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 (i.e., manufacturing processes requiring differentiation for the end user (3.50))
Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these.
Note 2 to entry: A 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.
[22]
[SOURCE: IMDRF/GRRP WG/N52:2019, 3.2, modified — added ‘or accessory’ and Notes to entry.]

a
At least one of these conditional distinct product identifiers is required.
Figure 2 — Relationship of terms used to describe distinct product identification

ISO/DIS 20417:2024(en)
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 contained in Clause A.2.
[SOURCE: IEC 60601-1:2005+AMD1:2012, 3.15, modified — Note 1 to entry added.]
3.8
distributor
natural or legal person, different from the manufacturer or importer (3.14), in the supply chain who, on their
own behalf, furthers the availability of a medical device (3.23) or accessory (3.1) to the user (3.50)
Note 1 to entry: More than one distributor may be involved in the supply chain.
Note 2 to entry: 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 (3.2) 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 to entry.]
3.9
e-documentation
electronic documentation
any form of electronically accessible information supplied by the manufacturer (3.15)
EXAMPLE CD/DVD-ROM, USB stick, website.
Note 1 to entry: See Figure 1.
3.10
essential principles of safety and performance
essential principles
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 medical device (3.23) 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 (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 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.
[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.]
ISO/DIS 20417:2024(en)
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).
3.13
importer
natural or legal person who imports a medical device (3.23) or accessory (3.1) that was manufactured in one
locale into another locale for the purposes of marketing
3.14
information for safety
information provided to the user (3.50) 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 (3.48) or
avoid a hazardous situation.
EXAMPLE 3 Explanation of a safety feature of a medical device or accessory.
Note 1 to entry: Information for safety may be found 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 medical device.
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 information supplied by the manufacturer.
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) directed to the user (3.50) that is 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.

ISO/DIS 20417:2024(en)
3.17
in vitro medical device
IVD 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 — replaced “device” with “medical device” and “human body” with
“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 interface (GUI) is considered as appearing on the item.
Note 4 to entry: See Figure 1.
[22]
[SOURCE: IMDRF/GRRP WG/N52:2019, 3.17, modified –added notes and replaced ‘unit’ and ‘devices’ with
‘item’.]
3.19
lay, adj
lay person
not having 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 (3.23)
EXAMPLE Lay user (3.18), 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, 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.
3.21
lot number
batch code
batch number
lot code
production control identifier containing a combination of letters or numbers associated with a single lot
(3.20) or batch (3.20)
ISO/DIS 20417:2024(en)
3.22
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device
(3.23) or accessory (3.1)
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.
[SOURCE: ISO 18113-1:2009, 2.4, modified — replaced ‘permanently’ with ‘durably’, deleted notes and added
Note 1 to entry and 'or accessory'.]
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,
— 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 — replaced “and/or” with “or” and “human being” and
“human body” with “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.

ISO/DIS 20417:2024(en)
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 may require processing between uses on a
single patient.
3.27
normal use
operation, including stand-by, routine inspection and adjustments by any user (3.50), in accordance with
the accompanying information (3.2) or, for those medical devices (3.23) provided without instructions for use
(3.16), with generally accepted practice
Note 1 to entry: Normal use should not be confused with 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, etc. as well.
Note 2 to entry: Use error (3.48) can occur in normal use.
Note 3 to entry: Medical devices that can be used safely without instructions for use are exempted from having
instructions for use by some authorities having jurisdiction (3.4).
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.9, modified — replaced “instructions for use” with “accompanying
information”, rearranged wording, added figure, replaced “authorities with jurisdiction” with “authorities
having jurisdiction” and replaced the figure.]
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 — deleted note 2.]
3.29
patient
subject of care
living being (person or animal) receiving healthcare services
Note 1 to entry: Healthcare services include diagnostic, therapeutic, monitoring, surgical or dental procedures and
can be delivered in the home healthcare environment, professional healthcare environment and emergency medical
services environment.
Note 2 to entry: A patient can be a user (3.50).
Note 3 to entry: Safety limit values can be different for different patients, especially for non-human patients.
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.76, modified — replaced “undergoing a medical,
surgical or dental procedure” with “receiving healthcare services” and added notes 1 and 3.]
3.30
pictogram
simplified pictorial representation, used to guide people and tell them how to achieve a certain goal
[SOURCE: ISO/IEC TR 20007:2014, 2.10]

ISO/DIS 20417:2024(en)
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.
Note 2 to entry: A healthcare product includes medical devices (3.23) and accessories (3.1).
[SOURCE: ISO 17664-2:2021, 3.10, modified — added note 1 and replaced “refers to a medical device” with
“includes medical devices and accessories” and replaced “activity” with “process”.]
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 associated items
Note 1 to entry: The responsible organization includes those individuals performing the activities for the responsible
organization including the preparation of the infrastructure needed to support the installation.
Note 2 to entry: The accountable organization can be, for example, a hospital, an individual clinician or a lay person.
In home use applications, the patient (3.29), user (3.50) and responsible organization can be one and the same person.
Note 3 to entry: Education and training are included in “use”.
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.101, modified — replaced “entity” with
“organization”, inserted “installation”, “processing” and “decommissioning or disposal”, replaced “ME
equipment or ME system” with “medical device, accessory and associated items”, and added note 1]
3.34
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 (3.42), gives a particular safety message
[SOURCE: ISO 7010:2019, 3.3]
3.35
serial number
production control identifier 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
(3.23) or accessory (3.1) from other medical devices or accessories with the same catalogue number (3.6) or
model number (3.25)
[SOURCE: ISO 14708-2:2012, 3.20, modified — added ‘production control identifier 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 or accessory from
other medical devices or accessories with the same catalogue number or model number’.]

ISO/DIS 20417:2024(en)
3.36
service personnel
organization (3.28) accountable to the responsible organization (3.33) that installs, assembles, maintains or
repairs a medical device (3.23) or accessory (3.1) and associated items
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.113, modified — replaced “individuals or entity”
with “organization” and “ME equipment, ME systems or equipment” with “a medical device, accessory and
associated items”.]
3.37
shelf-life
period during which a medical device (3.23) or accessory (3.1) in its original packaging maintains its stability
(3.40) under the conditions specified in the information supplied by the manufacturer (3.15)
[22]
[SOURCE: IMDRF/GRRP WG/N52:2019, 3.36, modified — replaced ‘by the manufacturer’ with ‘in the
information supplied by the manufacturer’ and deleted “of time until the expiry date”.]
3.38
single patient multiple use
intended by the manufacturer to be reused on an individual patient (3.29) for
multiple uses
Note 1 to entry: A single patient multiple use medical device (3.23) or accessory (3.1) may require processing (3.31)
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.
3.39
single use
do not re-use
use only once
intended by the manufacturer to be used on an individual patient (3.29) or
specimen during a single procedure and then disposed of
Note 1 to entry: A single use medical device (3.23) or accessory (3.1) is not intended by its manufacturer to be further
processed and used again.
3.40
stability
ability to maintain safety and performance characteristics within the
specifications in information supplied by the manufacturer (3.15)
Note 1 to entry: Stability applies to:
— medical devices (3.23) whose performance, physical, chemical or functional properties can be altered or
compromised over a stated time interval;
— the period over which sterility is assured;
— IVD reagents, calibrators and controls, when stored, transported and used in accordance with conditions specified
in the information sup
...