ISO/FDIS 20417
(Main)Medical devices — Information to be supplied by the manufacturer
Medical devices — Information to be supplied by the manufacturer
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.
Dispositifs médicaux — Informations à fournir par le fabricant
NOTE 1 Il y a des indications ou une justification pour cet Article figurant dans l'Article A.2. Le présent document spécifie les exigences relatives aux informations fournies par le fabricant pour un dispositif médical ou un accessoire, tel que défini en 3.1. Le présent document contient les exigences génériques communes concernant l’identification et l’étiquetage d’un dispositif médical ou d’un accessoire, l'emballage, le marquage d’un dispositif médical ou d’un accessoire et les informations d’accompagnement. Le présent document ne spécifie pas le mode de transmission des informations. NOTE 2 Certaines autorités compétentes imposent des exigences différentes concernant l’identification, le marquage et la documentation d’un dispositif médical ou d’un accessoire. Les exigences spécifiques des normes de produit relatives à un dispositif médical ou des normes de groupe prévalent sur les exigences du présent document.
General Information
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Standards Content (Sample)
FINAL DRAFT
International
Standard
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 2025-12-26
Voting terminates on:
2026-02-20
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
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
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
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ISO/CEN PARALLEL PROCESSING
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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ii
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
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
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
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
FINAL DRAFT International Standard ISO/FDIS 20417:2025(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 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 deviceproduct 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/
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
3.3
applicable policy
set of requirements relating to a product 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 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].
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 added.]
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.
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.
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].
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,
— 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”.]
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 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 responsible organization can be, for example, a hospital, an individual healthcare professional
provider or a lay person (3.19) user (3.49). In home use applications, the patient (3.29), user and responsible organization
can be one and the same person.
Note 3 to entry: Education and training are included in “use”.
Note 4 to entry: Adapted from IEC 60601-1:2005, 3.101.
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 symbol (3.42), gives a particular safety message
[SOURCE: ISO 7010:2019, 3.3. modified — “graphical symbol” was changed to “symbol”.]
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 product from
other products with the same catalogue number (3.6) or model number (3.25)
Note 1 to entry: Adapted from ISO 14708-2:2019, 3.18.
3.36
service personnel
organization (3.28) accountable to the responsible organization (3.33) for the installation assembly,
maintenance or repair a medical device (3.23) or accessory (3.1) and their detachable parts
Note 1 to entry: Adapted from IEC 60601-1:2005, 3.113.
3.37
shelf-life
period during which a product in its original packaging maintains its stability (3.40) under the conditions
specified in the information supplied by the manufacturer (3.15)
Note 1 to entry: Adapted from Reference [25].
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) can require processing (3.31)
between uses.
Note 2 to entry: For an implantable medical device, the duration from implanting to explanting the medical device is
considered single use (3.39) and not single patient multiple use.
3.39
single use
do not reuse
use only once
intended by the manufacturer to be used on an individual patient (3.29) or an
individual 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.
Note 2 to entry: For an implantable medical device, the duration from implanting to explanting the medical device is
considered single use and not single patient multiple use (3.38).
3.40
stability
ability to maintain safety and performance characteristics within the
specifications found 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;
— in vitro diagnostic (IVD) reagents, calibrators and controls, when stored, transported and used in accordance with
conditions specified in the information supplied by the manufacturer;
— reconstituted lyophilized materials, working solutions and material removed from sealed containers, when
prepared, used and stored according to the information supplied by the manufacturer;
— 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 time interval over which a measured property
...
ISO/TC 210/WG 2
2025-08-29
Secretariat: ANSI
Date: 2025-12-12
Medical devices — Information to be supplied by the manufacturer
Dispositifs médicaux — Informations à fournir par le fabricant
FDIS stage
TThihis drs draafftt i is s ssuubbmmiitttteedd ttoo aa ppaarraallellel l vvoottee i inn IISSOO,, CCEEN.N.
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'sISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 • CP 401 • Ch. de Blandonnet 8
CH-12111214 Vernier, Geneva 20
Tel.Phone: + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail: copyright@iso.org
WebWebsite: www.iso.org
Published in Switzerland.
ii © ISO 2024 – All rights reserved
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations . 16
5 Information elements to be established . 16
5.1 Units of measurement . 16
5.2 Graphical information . 17
5.3 Language and country identifiers . 17
5.4 Dates . 18
5.5 Full address . 18
5.6 Model number . 19
5.7 Catalogue number . 19
5.8 Production control identifiers . 19
5.9 Unique device identifier . 19
5.10 Types of use/reuse . 20
5.11 Sterile . 20
6 Requirements for accompanying information . 20
6.1 Requirements for information to be supplied on the label . 20
6.2 Identification requirements for detachable components of a medical device or accessory27
6.3 Legibility of the label . 28
6.4 Durability of markings . 28
6.5 Information to be provided on the packaging . 29
6.6 Requirements for information in the instructions for use and technical description . 33
7 Other information that is required to be supplied with the medical device or accessory . 44
7.1 Importer . 44
7.2 Distributor . 45
7.3 Repackaging . 45
7.4 Translation . 45
7.5 Regulatory identification . 46
Annex A (informative) Particular guidance and rationale . 47
Annex B (informative) Example test method for assessing clearly legible requirements . 50
Annex C (informative) Example test method for assessing durability . 51
Annex D (informative) Reference to the IMDRF essential principles and labelling guidance . 52
Annex E (informative) Alphabetized index of defined terms . 57
Bibliography . 79
iii
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 documentdocuments 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'sISO’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/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).
This second edition cancels and replaces the first edition (ISO 20417:2021), which has been technically
revised.
The main changes are as follows:
— — updatedupdate of the normative references;
— — deletion of the former informative Annexes D, F, G and H;
— — addition of the concept of term ‘applicable policy; andpolicy’;
— deletion of 4item b) andin Clause 4, and of item d) 1) in 6.1.2.d) 1).
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.
iv © ISO 2024 – All rights reserved
iv
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
[24[22]]
Devices, IMDRF/GRRP WG/N47:2024 on the information supplied by the manufacturer of a medical
device (see Annex DAnnex D););
— — the application of Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/GRRP
[25[23]]
WG/N52:2024 on the information supplied by the manufacturer of a medical device (see
Annex DAnnex D););
This document is organized in a structured manner. Clause 4Clause 4 contains general process requirements.
Clause 5Clause 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 6Clause 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.
v
FINAL DRAFT International Standard ISO/FDIS 20417:2025(en)
Medical devices — Information to be supplied by the manufacturer
1 Scope
NOTE 1 There is guidance or rationale for this Clause contained in A.2.1.
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 3.13.1. 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 productdeviceproduct 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 signsISOsigns
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/AMDAmd 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
definitions apply. apply.ISO and IEC maintain terminology databases for use in standardization at the
following addresses:
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/
NOTE An alphabetized index of defined terms used in this document is found in Annex EAnnex E.
3.1 3.1
accessory
item intended specifically by its manufacturer to be used together with one or more medical devices
(3.23(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(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 3.2
accompanying information
information supplied by the manufacturer (3.15(3.15)) with or marked (3.22(3.22)) on a medical device
(3.23(3.23)) or accessory (3.1(3.1)) for the user (3.49(3.49)) or responsible organization (3.33(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(3.18),), marking (3.22(3.22),), instructions
for use (3.16(3.16),), technical description (3.43(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(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(3.4).).
Note 5 to entry: See Figure 1Figure 1.
2 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
NOTE 1 The label (3.18(3.18)) can include the information on the packaging of the medical device (3.23(3.23)) or
accessory (3.1(3.1).).
NOTE 2 e-documentation (3.9(3.9)) can include any or all types of information supplied by the manufacturer partially
or entirely.
NOTE 3 ‘Marketing informationinformation’ is also known as ‘promotional materialmaterial’.
Figure 1 — Relationship of terms used to describe information supplied by the manufacturer
3.3 3.3
applicable policy
set of requirements relating to a product and its attributes such as form, fit, function, process or information
to be supplied by the manufacturer (3.15(3.15))
Note 1 to entry: The applicable policy is established by the authority having jurisdiction (3.4(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 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 3.5
authorized representative
organization (3.28(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 — replaced "" with "“natural or legal person", “with regard” was
changed to” with “regarding” and "his" with "their".] “organization”.]
3.6 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(3.23)) or accessory (3.1(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(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(3.4)) (e.g.,. US FDA ‘product code’ or procode classification).
Note 4 to entry: See Figure 2Figure 2.
Note 5 to entry: Adapted from Reference [23[21].].
4 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
a
At least one of these conditional distinct product identifiers is required.
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 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 A.2.2.
[SOURCE: IEC 60601-1:2005+AMD1:2012, 3.15, modified — Note 1 to entry added.]
3.8 3.8
distributor
organization (3.28(3.28),), different from the manufacturer or importer (3.13(3.13),), in the supply chain who,
on their own behalf, furthers the availability of a product to the user (3.49(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(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”
and ‘or accessory’ were was added; replaced, “natural or legal person” and “person” with was changed to
“organization” and “medical device” was changed to “product”; in Note 2 to entry 1 "may" with "can";“person”
were changed to “organization”; Note 3 to entry was added.]
3.9 3.9
e-documentation
electronic documentation
form of electronically accessible information supplied by the manufacturer (3.15(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(3.49)) interface (GUI).
EXAMPLE 2 Machine readable information such as a software bill of materials (SBOM).
Note 1 to entry: See Figure 1Figure 1.
3.10 3.10
essential principles
essential principles of safety and performance
fundamental high-level requirements that, when conformed with, ensure a medical device (3.23(3.23)) or
accessory (3.1(3.1)) is safe and performs as intended
3.11 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(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).
6 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
Note 4 to entry: There is guidance or rationale for this definition contained in A.2.3.
Note 5 to entry: Adapted from IEC 60601-1:2005+AMD1:2012, 3.28.
3.12 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 3.13
importer
organization (3.28(3.28)) who imports a product that was manufactured in one locale into another locale for
the purposes of marketing
3.14 3.14
information for safety
information provided to the user (3.49(3.49)) or responsible organization (3.33(3.33)) as a risk control
measure
EXAMPLE 1 Warnings, precautions or contraindications.
EXAMPLE 2 Instructions for the use (3.16(3.16)) of a medical device (3.23(3.23)) or accessory (3.1(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(3.15).).
Note 2 to entry: Information for safety can be located on the display of a product.
3.15 3.15
information supplied by the manufacturer
information related to the identification and use of a medical device (3.23(3.23)) or accessory (3.1(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(3.9)) is included in the 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(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 1Figure 1.
3.16 3.16
instructions for use
IFU
package insert
portion of the accompanying information (3.2(3.2)) that is
— -directed to the user (3.49(3.49); ), and
— - essential for the safe and effective use of a medical device (3.23 (3.23)) or accessory (3.1(3.1))
Note 1 to entry: A user can be either a lay (3.19(3.19) )user or professional user with relevant specialized training.
Note 2 to entry: Instructions for the professional processing (3.31(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(3.4).).
Note 5 to entry: See Figure 1Figure 1.
3.17 3.17
IVD medical device
in vitro medical device
medical device (3.23(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(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 — 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” withto “patient”.]
3.18 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(3.22)) on the medical device (3.23(3.23)) or accessory (3.1(3.1).).
Note 3 to entry: Information indicated on a graphical user (3.49(3.49)) interface (GUI) is considered as appearing on the
item.
Note 4 to entry: See Figure 1Figure 1.
Note 5 to entry: Adapted from Reference [25[23].].
3.19 3.19
lay, adj
lay person, adj
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(3.23))
EXAMPLE Lay user (3.49(3.49),), lay responsible organization (3.33(3.33).).
8 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
3.20 3.20
lot
batch
defined amount of material or a defined number of medical devices (3.23(3.23),), including finished product
and accessories (3.1(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, andare 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 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(3.20))
3.22 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 1Figure 1.
Note 4 to entry: Adapted from ISO 18113-1:2022, 3.1.43.
3.23 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 (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” withwere changed to “patient”.]
3.24 3.24
medical device family
group of medical devices (3.23(3.23)) manufactured by or for the same organization (3.28(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 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(3.23), ),accessory (3.1(3.1)) or medical device family (3.24(3.24)) from another
Note 1 to entry: See Figure 2Figure 2.
3.26 3.26
multiple patient multiple use
intended by the manufacturer to be reused on multiple patients (3.29(3.29)) for
multiple uses
Note 1 to entry: A multiple patient multiple use medical device (3.23(3.23)) or accessory (3.1(3.1)) typically requires
processing (3.31(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 3.27
normal use
operation, including stand-by, routine inspection and adjustments by any user (3.49(3.49),), in accordance
with the accompanying information (3.2(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(3.31),), etc. as well.
10 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
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(3.4).).
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.9, modified — in the definition, “instructions for use” was
replaced with changed to “accompanying information” and replaced Notes 1 and ”; in Note 3 to entry.],
“medical devices” was changed to “healthcare products”.]
3.28 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 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(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+AMD1:2012+AMD2:2020, 3.76.
3.30 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 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 —replaced “activity” was changed to “processes”; Note 1 to entry
was changed.]
3.32 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(3.12))
Note 1 to entry: Product standards are sometimes referred to as vertical standards.
3.33 3.33
responsible organization
organization (3.28(3.28)) accountable for the installation, use, processing (3.31(3.31),), maintenance,
decommissioning or disposal of a medical device (3.23(3.23),), accessory (3.1(3.1)) and their detachable parts
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 responsible organization can be, for example, a hospital, an individual healthcare professional
provider or a lay person (3.19(3.19)) user (3.49(3.49).). In home use applications, the patient (3.29(3.29),), user and
responsible organization can be one and the same person.
Note 3 to entry: Education and training are included in “use”.
Note 4 to entry: Adapted from IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.101.
3.34 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 symbol (3.42(3.42),), gives a particular safety message
[SOURCE: ISO 7010:2019, 3.3. modified – deleted — “graphical.] symbol” was changed to “symbol”.]
3.35 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 product from
other products with the same catalogue number (3.6(3.6)) or model number (3.25(3.25))
Note 1 to entry: Adapted from ISO 14708-2:20122019, 3.2018.
3.36 3.36
service personnel
organization (3.28(3.28)) accountable to the responsible organization (3.33(3.33)) for the installation
assembly, maintenance or repair a medical device (3.23(3.23)) or accessory (3.1(3.1)) and their detachable
parts
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.113, modified — replaced “individuals or entity”
with “organization” “that install, assemble, maintain” with “for the installation, assembly, maintenance” and
“ME equipment, ME systems or equipment” with “a medical device, accessory and their detachable parts”.]
3.37
Note 1 to entry: Adapted from IEC 60601-1:2005, 3.113.
12 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
3.37
shelf-life
period during which a product in its original packaging maintains its stability (3.40 (3.40)) under the
conditions specified in the information supplied by the manufacturer (3.15(3.15))
Note 1 to entry: Adapted from Reference [25[23].].
3.373.38 3.38
single patient multiple use
intended by the manufacturer to be reused on an individual patient (3.29(3.29))
for multiple uses
Note 1 to entry: A single patient multiple use medical device (3.23(3.23)) or accessory (3.1(3.1)) can require processing
(3.31(3.31)) between uses.
Note 2 to entry: For an implantable medical device, the duration from implanting to explanting the medical device is
considered single use (3.39(3.39)) and not single patient multiple use.
3.383.39 3.39
single use
do not reuse
use only once
intended by the manufacturer to be used on an individual patient (3.29(3.29)) or
an individual specimen during a single procedure and then disposed of
Note 1 to entry: A single use medical device (3.23(3.23)) or accessory (3.1(3.1)) is not intended by its manufacturer to be
further processed and used again.
Note 2 to entry: For an implantable medical device, the duration from implanting to explanting the medical device is
considered single use and not single patient multiple use (3.38(3.38).).
3.393.40 3.40
stability
ability to maintain safety and performance characteristics within the
specifications found in information supplied by the manufacturer (3.15(3.15))
Note 1 to entry: Stability applies to:
— — medical devices (3.23(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;
— — in vitro diagnostic (IVD) reagents, calibrators and controls, when stored, transported and used in accordance
with conditions specified in the information supplied by the manufacturer;
— — 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 time interval over which a measured property changes by a stated amount; or
— — in terms of the change of a property under specified conditions.
3.403.41 3.41
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.413.42 3.42
symbol
graphical representation appearing on the label (3.18(3.18)) or in accompanying information (3.2(3.2)) of a
product 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 representation, a graphical representation, or one that uses familiar
objects, including alphanumeric characters (with sufficient justification).
3.423.43 3.43
technical description
portion of the accompanying information (3.2(3.2)) that is:
— - directed to the responsible organization (3.33(3.33)) and service personnel (3.36(3.36);), and
— - essential for installation, preparation for the first use and safe use, maintenance or repair, as well as
processing (3.31(3.31),), transport or storage for the expected lifetime (3.11(3.11)) including
decommissioning or disposal of a medical device (3.23(3.23)) or accessory (3.1(3.1) )
Note 1 to entry: The technical description can be included in the instructions for use (3.16(3.16).).
Note 2 to entry: See Figure 1Figure 1.
3.433.44 3.44
UDI carrier
unique device identification carrier
means to convey the unique device identification (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.
Note 2 to entry: Adapted from Reference [26[24].].
3.443.45 3.45
usability
characteristic of the user (3.49(3.49)) interface that facilitates use and thereby establishes use effectiveness,
use efficiency and user satisfaction in the intended use environment (3.47(3.47))
Note 1 to entry: All aspects of usability, including use effectiveness, use efficiency and user satisfaction, can either
increase or decrease safety.
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.16, modified — replacedadded “use” in front of “effectiveness”
with “use effectiveness” and “efficiency” with “use efficiency”.]
14 © ISO 2024 – All rights reserved
ISO/DISFDIS 20417:2025(en)
3.453.46 3.46
usability engineering
human factors engineering
application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design
of products and user (3.49(3.49)) tasks to achieve adequate usability (3.45(3.45))
Note 1 to entry: Achieving adequate usability can result in acceptable risk related to use.
Note 2 to entry: Products include medical devices (3.23(3.23),), accessories (3.1(3.1)) and health software.
[SOURCE: IEC 62366-1:2015+AMD1:2020, 3.17, mo
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