ISO/FDIS 17966
(Main)Assistive products for toileting, bathing and showering — Requirements and test methods
General Information
- Abstract
This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others. The work environment and safety aspects for assistants are also included. It specifies safety and performance requirements that apply during normal use and foreseeable misuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and specifies limits on the forces needed for some operations. This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999: 09 12 03 Commode chairs; 09 12 06 Toilets; 09 12 09 Toilet seats; 09 12 10 Toilet splash guards; 09 12 12 Raised toilet seats mounted on frame; 09 12 15 Toilet seats inserts; 09 12 18 Raised toilet seats fixed to toilet; 09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down; 09 12 24 Toilet arm supports and toilet back supports mounted on toilet; 09 12 25 Toilet arm supports and toilet back supports, free standing; 09 12 36 Douches and air dryers for attachment to a toilet; 09 33 04 Bath boards 09 33 05 Bath seats 09 33 07 Shower chairs with and without wheels 09 33 08 Back supports for bath or shower 09 33 12 Bathing stretchers, shower tables and diaper-changing tables; NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1 and EN 12221-2. 09 33 15 Wash basins NOTE: General requirements for wash basins are covered by EN 14688. 09 33 18 Bidets 09 33 21 Bathtubs 09 33 36 Assistive products for drying oneself 18 15 06 Height adjustable plinths and brackets; 18 18 03 Handrails and support rails; 18 18 06 Fixed grab bars and handgrips; 18 18 10 Removable grab rails and handgrips; 18 18 11 Hinged rails and arm supports; This document does not encompass requirements regarding: — safe mounting in building structures; — fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and -wrapping systems; — 12 36 15 bathtub hoists that are covered by ISO 10535; — 09 33 21 Bathtubs — stability and friction issues in relation to slippery surfaces due to soap; — products that have been customised or custom-made for an individual user. NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022
- Status
- Not Published
- Technical Committee
- ISO/TC 173 - Assistive products
- Drafting Committee
- ISO/TC 173 - Assistive products
- Current Stage
- 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
- Start Date
- 28-Jul-2026
- Completion Date
- 28-Jul-2026
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Overview
ISO/FDIS 17966: Assistive products for toileting, bathing and showering - Requirements and test methods is an international standard developed by ISO. It provides a comprehensive framework for the safety, performance, and test methods of assistive products designed to support toileting, bathing, and showering. These products, often intended for people with disabilities and commonly classified as medical devices, include items such as commode chairs, toilets, toilet seats, splash guards, shower chairs, bath boards, and various supports.
The standard aims to ensure not only the safety and accessibility for users but also addresses safety concerns for assistants. It specifies requirements that cover normal use, foreseeable misuse, and predictable failure scenarios, thereby enhancing the overall reliability and usability of assistive devices in different care environments.
Key Topics
This standard covers a wide range of requirements and test methods, including:
- General Safety Requirements: Addresses risk analysis, intended performance, and clinical evaluation.
- Measurement of Forces: Defines how controlling and operating forces are measured and the acceptable limits for user operation.
- Material Properties: Specifies standards for flammability, toxicity, biocompatibility, and resistance to corrosion.
- Hygiene and Cleaning: Outlines requirements for cleaning, disinfection, and infection control.
- Sound and Vibration: Sets limitations and testing methods for emitted noise and vibrations to enhance user comfort.
- Electrical Safety: Covers battery-powered and electrically operated products, ensuring safety from electrical hazards and ingress of liquids.
- Mechanical Safety: Includes stability, static strength, durability, ergonomic considerations, and prevention of trapping for body parts.
- Ergonomics and User-Centric Design: Focuses on ease of use, accessibility, and minimizing operational forces for users with physical limitations.
- Special Requirements for Children: Addresses adaptations and additional safety for pediatric users.
- Information and Documentation: Defines what manufacturers must supply in instruction manuals, user guidelines, and labeling.
Applications
Assistive products covered by ISO/FDIS 17966 serve a vital function in a range of environments, including:
- Healthcare Facilities: Ensuring accessible and reliable equipment for patients needing support with toileting or bathing.
- Home Care Settings: Enabling greater independence for people with disabilities, the elderly, or those temporarily impaired.
- Rehabilitation Centers: Providing safe and supportive tools to facilitate recovery and daily living activities.
- Public Accessibility Installations: Guiding manufacturers and facility managers in selecting compliant and safe products for public restrooms and showers.
The standard applies to a diverse range of products (as classified by ISO 9999), including:
- Commode chairs, toilets, raised toilet seats, and various toilet supports.
- Bath boards, bath seats, shower chairs (with or without wheels), and bathing stretchers.
- Handrails, grab bars (fixed or removable), hinged rails, and arm supports.
- Wash basins, bidets, bathtubs (with certain scope exclusions), and assistive products for drying oneself.
Related Standards
For comprehensive safety and compatibility, ISO/FDIS 17966 references and works alongside several other international standards, including:
- ISO 9999: Classification of assistive products for persons with disability.
- ISO 10535: Hoists for the transfer of disabled persons - excluded for bathtub hoists.
- EN 12221-1 & EN 12221-2: Mainstream diaper-changing tables for babies and toddlers.
- EN 14688: General requirements for wash basins.
Adhering to ISO/FDIS 17966 helps manufacturers, regulators, and care providers ensure safer, more reliable, and user-friendly assistive products, thus enhancing accessibility and quality of life for people with disabilities. Manufacturers can leverage compliance as a mark of quality, supporting both user confidence and regulatory acceptance worldwide.
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 15-Oct-2022
- Effective Date
- 06-Jun-2022
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Frequently Asked Questions
ISO/FDIS 17966 is a draft published by the International Organization for Standardization (ISO). Its full title is "Assistive products for toileting, bathing and showering — Requirements and test methods". This standard covers: This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others. The work environment and safety aspects for assistants are also included. It specifies safety and performance requirements that apply during normal use and foreseeable misuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and specifies limits on the forces needed for some operations. This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999: 09 12 03 Commode chairs; 09 12 06 Toilets; 09 12 09 Toilet seats; 09 12 10 Toilet splash guards; 09 12 12 Raised toilet seats mounted on frame; 09 12 15 Toilet seats inserts; 09 12 18 Raised toilet seats fixed to toilet; 09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down; 09 12 24 Toilet arm supports and toilet back supports mounted on toilet; 09 12 25 Toilet arm supports and toilet back supports, free standing; 09 12 36 Douches and air dryers for attachment to a toilet; 09 33 04 Bath boards 09 33 05 Bath seats 09 33 07 Shower chairs with and without wheels 09 33 08 Back supports for bath or shower 09 33 12 Bathing stretchers, shower tables and diaper-changing tables; NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1 and EN 12221-2. 09 33 15 Wash basins NOTE: General requirements for wash basins are covered by EN 14688. 09 33 18 Bidets 09 33 21 Bathtubs 09 33 36 Assistive products for drying oneself 18 15 06 Height adjustable plinths and brackets; 18 18 03 Handrails and support rails; 18 18 06 Fixed grab bars and handgrips; 18 18 10 Removable grab rails and handgrips; 18 18 11 Hinged rails and arm supports; This document does not encompass requirements regarding: — safe mounting in building structures; — fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and -wrapping systems; — 12 36 15 bathtub hoists that are covered by ISO 10535; — 09 33 21 Bathtubs — stability and friction issues in relation to slippery surfaces due to soap; — products that have been customised or custom-made for an individual user. NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022
This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others. The work environment and safety aspects for assistants are also included. It specifies safety and performance requirements that apply during normal use and foreseeable misuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and specifies limits on the forces needed for some operations. This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999: 09 12 03 Commode chairs; 09 12 06 Toilets; 09 12 09 Toilet seats; 09 12 10 Toilet splash guards; 09 12 12 Raised toilet seats mounted on frame; 09 12 15 Toilet seats inserts; 09 12 18 Raised toilet seats fixed to toilet; 09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down; 09 12 24 Toilet arm supports and toilet back supports mounted on toilet; 09 12 25 Toilet arm supports and toilet back supports, free standing; 09 12 36 Douches and air dryers for attachment to a toilet; 09 33 04 Bath boards 09 33 05 Bath seats 09 33 07 Shower chairs with and without wheels 09 33 08 Back supports for bath or shower 09 33 12 Bathing stretchers, shower tables and diaper-changing tables; NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1 and EN 12221-2. 09 33 15 Wash basins NOTE: General requirements for wash basins are covered by EN 14688. 09 33 18 Bidets 09 33 21 Bathtubs 09 33 36 Assistive products for drying oneself 18 15 06 Height adjustable plinths and brackets; 18 18 03 Handrails and support rails; 18 18 06 Fixed grab bars and handgrips; 18 18 10 Removable grab rails and handgrips; 18 18 11 Hinged rails and arm supports; This document does not encompass requirements regarding: — safe mounting in building structures; — fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and -wrapping systems; — 12 36 15 bathtub hoists that are covered by ISO 10535; — 09 33 21 Bathtubs — stability and friction issues in relation to slippery surfaces due to soap; — products that have been customised or custom-made for an individual user. NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022
ISO/FDIS 17966 is classified under the following ICS (International Classification for Standards) categories: 11.180.01 - Aids for disabled and handicapped persons in general; 11.180.99 - Other standards related to aids for disabled and handicapped people. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/FDIS 17966 has the following relationships with other standards: It is inter standard links to FprEN ISO 17966, ISO 8502-15:2020, ISO 17966:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO/FDIS 17966 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
DRAFT
International
Standard
ISO/DIS 17966
ISO/TC 173
Assistive products for toileting,
Secretariat: SIS
bathing and showering —
Voting begins on:
Requirements and test methods
2024-11-04
ICS: 11.180.99; 11.180.01
Voting terminates on:
2025-01-27
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 17966:2024(en)
DRAFT
ISO/DIS 17966:2024(en)
International
Standard
ISO/DIS 17966
ISO/TC 173
Assistive products for toileting,
Secretariat: SIS
bathing and showering —
Voting begins on:
Requirements and test methods
ICS: 11.180.99; 11.180.01
Voting terminates on:
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,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 17966:2024(en)
ii
ISO/DIS 17966:2024(en)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 3
3 Terms and definitions . 5
4 General requirements and test methods . 9
4.1 Risk analysis .9
4.2 Intended performance .9
4.3 Clinical evaluation and investigation .9
4.4 Assistive products for personal hygiene that can be dismantled .9
4.5 Fasteners .9
4.6 User mass/load limits .10
4.7 Apparatus .10
4.7.1 Means to apply a force .10
4.7.2 Means to measure force .10
4.7.3 Means to measure distance .10
4.7.4 Means to measure angles .10
4.7.5 Means to measure torque .10
4.7.6 Means to measure sound pressure levels .10
4.7.7 Test plane .10
4.7.8 Stoppers.10
4.7.9 Box . .11
4.7.10 Equipment for applying loads .11
4.7.11 Equipment for measuring pressure of water, oil and air .11
4.7.12 Loading pads .11
4.7.13 Equipment for impact test .16
4.7.14 Supporting stands .19
4.7.15 Small parts cylinder . 20
4.7.16 Obstruction .21
4.7.17 Hardwood vertical obstacle .21
4.8 Test conditions .21
5 Materials .21
5.1 General .21
5.2 Flammability .21
5.2.1 General .21
5.2.2 Upholstered parts. 22
5.2.3 Other soft parts . 22
5.2.4 Polymeric parts . 22
5.2.5 Wiring . 22
5.3 Biocompatibility and toxicity . 23
5.4 Infection and microbiological contamination . 23
5.4.1 Cleaning and disinfection . 23
5.4.2 Animal tissue .24
5.5 Resistance to corrosion .24
6 Emitted sound and vibration .24
6.1 Noise and vibration .24
6.2 Sound pressure levels and frequencies of audible warning devices .24
7 Electromagnetic compatibility .25
8 Electrical safety .25
8.1 General . 25
8.2 Battery powered assistive products – charge level indicator . 25
8.3 Electrically heated blankets, pads and similar flexible heating appliances . 25
iii
ISO/DIS 17966:2024(en)
8.4 Ingress of liquids or particulate matter . 25
8.4.1 Ingress of liquids . 25
8.4.2 Ingress of particulate matter . 26
8.5 Pendant controls . 26
9 Overflow, leakage, and ingress of liquids .26
9.1 Ingress of liquids . . . 26
9.1.1 Requirements . 26
9.1.2 Test method .27
9.2 Overflow and leakage .27
9.2.1 General .27
9.2.2 Substances which may leak from an assistive product in intended use and in
fault conditions .27
10 Temperatures of parts that come in contact with human skin .27
11 Safety of moving and folding parts .28
11.1 Moving parts . 28
11.2 Folding parts . 29
11.3 Velocity of powered lifting and lowering movements . 29
11.3.1 Requirements . 29
11.3.2 Test method . 29
11.4 Mechanical wear . 29
11.5 Trapping zones for feet in relation to moving parts. 29
12 Means to prevent falling out .30
12.1 General . 30
12.2 Side rails to protect against inadvertent user falls .31
13 Prevention of traps for parts of the human body .32
13.1 Holes and clearances .32
13.2 V-shaped openings .32
14 Folding and adjusting mechanisms .32
14.1 General .32
14.2 Locking mechanisms . 33
15 Lifting and carrying means .33
15.1 General . 33
15.2 Requirement . 33
15.3 Test method . 33
16 Portable and hand-held assistive products or hand-held parts .34
17 Static strength, impact and durability .34
17.1 General . 34
17.2 Formulae . 35
17.2.1 Formulae for calculating forces . 35
17.3 Number of test cycles for durability . 38
17.4 Static strength . . 40
17.4.1 Requirements . 40
17.4.2 Test methods . 40
17.5 Durability . 46
17.5.1 Requirements . 46
17.5.2 Test methods .47
17.6 Impact . 53
17.6.1 Requirements . 53
17.6.2 Test methods . 53
18 Stability .56
18.1 Requirements . 56
18.2 Test methods . 56
19 Surfaces, corners, edges and protruding parts .57
iv
ISO/DIS 17966:2024(en)
20 Assistive products for children .57
21 Forces in soft tissues of the human body .57
22 Ergonomic principles .57
23 Mobile assistive products .58
23.1 General . 58
23.2 Immobilizing means . 58
23.2.1 General . 58
23.2.2 Requirements for locking devices . 58
23.2.3 Test methods for locking devices . 58
23.2.4 Test methods for durability of brakes .59
23.2.5 Brake operated by a lever .59
23.3 Electrical safety for mobile assistive products .59
23.3.1 Power-driven mobile assistive products .59
23.4 Rough handling and movement .59
23.4.1 General .59
23.4.2 Requirements .59
23.4.3 Test method for movement over a threshold .59
23.4.4 Test method for door frame shock . 60
23.5 Functional requirements for mobile assistive products . 60
23.5.1 Foot supports . 60
23.5.2 Position of push handles/points . 60
23.5.3 Turning diameter of mobile assistive products . 60
23.6 Moving forces . .61
23.6.1 Requirements for moving forces .61
23.6.2 Test methods for moving forces.61
24 Fixed assistive products . 61
24.1 General .61
24.2 Requirements .62
24.3 Shower seats .62
24.3.1 Description .62
24.3.2 Test methods .62
24.4 Bathing stretchers, shower tables and diaper changing tables . 64
24.4.1 Description . 64
24.4.2 Test methods . 64
24.5 Bath boards, back supports and seats . 64
24.5.1 Description . 64
24.5.2 Test method for durability . 65
24.6 Raised toilet seats . 65
24.6.1 Description . 65
24.6.2 Requirements . 65
24.6.3 Test methods . 66
24.7 Handrails, grab bars and handgrips .67
24.7.1 Description .67
24.7.2 Ergonomic principles . .67
24.7.3 Test methods .67
24.8 Removable grab rails and handgrips . 68
24.8.1 Description . 68
24.8.2 Ergonomic principles . 68
24.8.3 Test methods . 69
24.9 Hinged rails and arm supports .70
24.9.1 Description .70
24.9.2 General .70
24.9.3 Test methods .70
25 Portable assistive products .71
25.1 General .71
25.2 Stability and strength tests . .71
v
ISO/DIS 17966:2024(en)
25.3 Raised toilet seats, detachable .71
25.3.1 Description .71
25.3.2 Requirements .71
25.4 Toilet seats with built-in raising mechanism to help standing up and sitting down (non-
fixed) .71
25.4.1 Description .71
25.4.2 Durability .71
25.5 Bath boards, stools, back supports and seats . 72
25.5.1 Description . 72
25.5.2 Materials . 72
25.5.3 Stability . 72
25.5.4 Stability tests for assistive products designed to be supported by the sides of a
bathtub . 72
25.5.5 Strength test of brackets . 77
25.5.6 Friction test of bath board/seat . 80
25.5.7 Static horizontal force test on handle . 81
25.5.8 Static vertical force test of handle . 81
25.6 Arm support, free-standing . 82
25.6.1 Requirements . 82
25.6.2 Test methods . 82
26 Requirements for information supplied by the manufacturer .82
26.1 General . 82
26.2 Instructions for use . 83
26.2.1 General . 83
26.2.2 Pre-sale information . 83
26.2.3 User information . 84
26.2.4 Service information . 85
26.3 Labelling . 85
27 Packaging.86
28 Test report .86
Annex A (informative) Cognitive impairment .88
Annex B (informative) General recommendations .89
Annex C (informative) Environmental and consumer-related requirements .96
Annex D (informative) Periodic inspection .101
Annex E (informative) Lithium batteries .102
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .104
Bibliography .107
vi
ISO/DIS 17966:2024(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).
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 173, Assistive products, respectively
ISO/TC 173/WG 9, Assistive products for personal hygiene.
This document is foreseen to be adopted as an EN-ISO Standard by Technical Committee CEN/TC 293,
Assistive products and accessibility falling under Standardization Request M/575 given to CEN by the
European Commission and the European Free
...
FINAL DRAFT
International
Standard
ISO/TC 173
Assistive products for toileting,
Secretariat: SIS
bathing and showering —
Voting begins on:
Requirements and test methods
2026-07-28
Produits d’assistance pour les toilettes, le bain et la douche —
Voting terminates on:
Exigences et méthodes d’essai
2026-09-22
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 173
Assistive products for toileting,
Secretariat: SIS
bathing and showering —
Voting begins on:
Requirements and test methods
Produits d’assistance pour les toilettes, le bain et la douche —
Voting terminates on:
Exigences et méthodes d’essai
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 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .vii
Introduction .ix
1 Scope . 1
2 Normative references . 3
3 Terms and definitions . 4
4 General requirements . 8
4.1 General .8
4.2 Risk analysis .8
4.3 Intended performance .9
4.4 Clinical evaluation and investigation .9
4.5 Assistive products that can be dismantled .9
4.6 Fasteners .9
4.7 User mass/load limits .9
4.8 Apparatus .10
4.8.1 Means to apply a force .10
4.8.2 Means to measure force .10
4.8.3 Means to measure distance .10
4.8.4 Means to measure angles .10
4.8.5 Means to measure torque .10
4.8.6 Means to measure sound pressure levels .10
4.8.7 Test plane .10
4.8.8 Stoppers.10
4.8.9 Box . .11
4.8.10 Equipment for applying loads .11
4.8.11 Equipment for measuring pressure of water, oil and air .11
4.8.12 Loading pads .11
4.8.13 Equipment for impact test .16
4.8.14 Supporting stands .19
4.8.15 Small parts cylinder . 20
4.8.16 Obstruction .21
4.8.17 Hardwood vertical obstacle .21
4.9 Test conditions .21
5 Materials .21
5.1 General .21
5.2 Flammability .21
5.2.1 General .21
5.2.2 Upholstered parts and other soft parts . 22
5.2.3 Polymeric parts . 22
5.2.4 Wiring . 22
5.3 Biocompatibility and toxicity . 22
5.4 Infection and microbiological contamination . 23
5.4.1 Cleaning and disinfection . 23
5.4.2 Animal tissue .24
5.5 Resistance to corrosion .24
6 Emitted sound and vibration .24
6.1 Noise and vibration .24
6.2 Sound pressure levels and frequencies of audible warning devices .24
7 Electromagnetic compatibility .24
8 Electrical safety .25
8.1 General . 25
8.2 Battery powered assistive products – charge level indicator . 25
8.3 Electrically heated blankets, pads and similar flexible heating appliances . 25
iii
8.4 Ingress of liquids or particulate matter . 25
8.4.1 Ingress of liquids . 25
8.4.2 Ingress of particulate matter . 26
8.5 Pendant controls . 26
9 Overflow, leakage, and ingress of liquids .26
9.1 Ingress of liquids . . . 26
9.1.1 Requirements . 26
9.1.2 Test method . 26
9.2 Overflow and leakage .27
9.2.1 General .27
9.2.2 Prevention of leaks from an assistive product .27
10 Temperatures of parts that come in contact with human skin .27
11 Safety of moving and folding parts .28
11.1 Moving parts . 28
11.2 Folding parts . 29
11.3 Locking mechanisms . 29
11.4 Velocity of powered lifting and lowering movements . 29
11.4.1 Requirements . 29
11.4.2 Test method . 29
11.5 Mechanical wear . 30
11.6 Trapping zones for feet and toes in relation to moving parts . 30
12 Means to prevent falling out .31
12.1 General .31
12.2 Side rails to protect against inadvertent user falls .31
13 Prevention of traps for parts of the human body .32
13.1 Holes and clearances .32
13.2 V-shaped openings .32
14 Lifting and carrying means .33
14.1 General . 33
14.2 Requirement . 33
14.3 Test method . 33
15 Portable and hand-held assistive products or hand-held parts .34
16 Static strength, impact and durability .34
16.1 General . 34
16.2 Formulae for calculating forces . 35
16.3 Number of test cycles for durability .37
16.4 Static strength . . 38
16.4.1 Requirements . 38
16.4.2 Test methods . 39
16.5 Durability .45
16.5.1 Requirements .45
16.5.2 Test methods . 46
16.6 Impact . 53
16.6.1 Requirements . 53
16.6.2 Test methods . 53
17 Stability .56
17.1 Requirements . 56
17.2 Test methods . 56
18 Surfaces, corners, edges and protruding parts .57
19 Assistive products for children .57
20 Forces in soft tissues of the human body .57
21 Ergonomic principles .57
iv
22 Mobile assistive products .58
22.1 General . 58
22.2 Immobilizing means . 58
22.2.1 General . 58
22.2.2 Requirements for locking devices . 58
22.2.3 Test methods for locking devices . 58
22.2.4 Test methods for durability of brakes .59
22.2.5 Brake-operated by a lever .59
22.3 Power-driven mobile assistive products .59
22.4 Rough handling and movement .59
22.4.1 General .59
22.4.2 Requirements .59
22.4.3 Test method for movement over a threshold .59
22.4.4 Test method for door frame shock . 60
22.5 Functional requirements for mobile assistive products . 60
22.5.1 Foot supports . 60
22.5.2 Position of push handles or points . 60
22.5.3 Turning diameter of mobile assistive products . 60
22.6 Moving forces . .61
22.6.1 Requirements for moving forces .61
22.6.2 Test methods for moving forces.61
23 Fixed assistive products . 61
23.1 General .61
23.2 Requirements .62
23.3 Shower seats .62
23.3.1 Description .62
23.3.2 Test methods .62
23.4 Bathing stretchers, shower tables and diaper changing tables . 64
23.4.1 Description . 64
23.4.2 Test methods . 64
23.5 Bath boards, back supports and seats . 65
23.5.1 Description . 65
23.5.2 Test method for durability . 65
23.6 Raised toilet seats . 66
23.6.1 Description . 66
23.6.2 Requirements . 66
23.6.3 Test methods . 66
23.7 Handrails, grab bars and handgrips .67
23.7.1 Description .67
23.7.2 Ergonomic principles . 68
23.7.3 Requirements . 68
23.7.4 Test methods . 68
23.8 Removable grab rails and handgrips . 69
23.8.1 Description . 69
23.8.2 Ergonomic principles . 69
23.8.3 Safety .70
23.8.4 Test methods .70
23.9 Hinged rails and arm supports .71
23.9.1 Description .71
23.9.2 General .71
23.9.3 Test methods .71
24 Portable assistive products . .72
24.1 General . 72
24.2 Stability and strength tests . . 72
24.3 Raised toilet seats, detachable . 72
24.3.1 Description . 72
24.3.2 Requirements . 72
v
24.4 Toilet seats with built-in raising mechanism to help standing up and sitting down (non-
fixed) . 72
24.4.1 Description . 72
24.4.2 Durability . 73
24.5 Bath boards, stools, back supports and seats . 73
24.5.1 Description . 73
24.5.2 Materials . 73
24.5.3 Stability . 73
24.5.4 Stability tests for assistive products designed to be supported by the sides of a
bathtub . 73
24.5.5 Strength test of brackets . 78
24.5.6 Friction test of bath board or seat . 81
24.5.7 Static horizontal force test on handle . 82
24.5.8 Static vertical force test of handle . 82
24.6 Arm support, free-standing . 83
24.6.1 Requirements . 83
24.6.2 Test methods . 83
25 Requirements for information supplied by the manufacturer .83
25.1 General . 83
25.2 Instructions for use . 84
25.2.1 General . 84
25.2.2 Pre-sale information . 84
25.2.3 User information . 85
25.2.4 Service information . 86
25.3 Labelling . 86
26 Packaging.87
27 Test report .87
Annex A (informative) Cognitive impairment .89
Annex B (informative) General recommendations .90
Annex C (informative) Environmental and consumer-related recommendations .98
Annex D (informative) Periodic inspection .103
Annex E (informative) Lithium batteries .104
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .106
Bibliography .108
vi
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 173, Assistive products, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive products
and accessibility, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO 17966:2016), which has been technically
revised.
The main changes are as follows:
— new terms and definitions were added, and a few definitions updated (Clause 3);
— new apparatus was added and a few updated (4.8);
— requirements for flammability were updated, and requirements for other soft parts, polymeric parts and
wiring were added (5.2);
— requirements for infection and microbiological contamination were updated, and requirements, test
methods, performance criteria and marking requirements for machine washable assistive products
were added (5.4);
— requirements for electromagnetic compatibility were removed from this document, reference to
requirements in IEC 60601-1:2005 was added instead (Clause 7);
— reference to electrical standards was adjusted, and requirements for electrical syste
...
ISO/TC 173
Secretariat: SIS
Date: 2026-06-0305
Assistive products for toileting, bathing and showering —
Requirements and test methods
Produits d’assistance pour les toilettes, le bain et la douche — Exigences et méthodes d’essai
FDIS stage
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents
Foreword . vi
Introduction . viii
1 Scope . 1
2 Normative references . 3
3 Terms and definitions . 4
4 General requirements . 9
4.1 General . 9
4.2 Risk analysis . 9
4.3 Intended performance . 9
4.4 Clinical evaluation and investigation . 9
4.5 Assistive products that can be dismantled . 10
4.6 Fasteners . 10
4.7 User mass/load limits . 10
4.8 Apparatus . 10
4.9 Test conditions . 21
5 Materials . 21
5.1 General . 21
5.2 Flammability . 21
5.3 Biocompatibility and toxicity . 22
5.4 Infection and microbiological contamination . 23
5.5 Resistance to corrosion . 24
6 Emitted sound and vibration . 24
6.1 Noise and vibration . 24
6.2 Sound pressure levels and frequencies of audible warning devices . 24
7 Electromagnetic compatibility . 25
8 Electrical safety . 25
8.1 General . 25
8.2 Battery powered assistive products – charge level indicator . 25
8.3 Electrically heated blankets, pads and similar flexible heating appliances . 25
8.4 Ingress of liquids or particulate matter . 26
8.5 Pendant controls . 26
9 Overflow, leakage, and ingress of liquids . 27
9.1 Ingress of liquids . 27
9.2 Overflow and leakage . 27
10 Temperatures of parts that come in contact with human skin . 27
11 Safety of moving and folding parts . 28
11.1 Moving parts . 28
11.2 Folding parts . 29
11.3 Locking mechanisms. 30
11.4 Velocity of powered lifting and lowering movements . 30
11.5 Mechanical wear. 30
11.6 Trapping zones for feet and toes in relation to moving parts . 30
12 Means to prevent falling out . 31
12.1 General . 31
iii
12.2 Side rails to protect against inadvertent user falls . 32
13 Prevention of traps for parts of the human body . 33
13.1 Holes and clearances . 33
13.2 V-shaped openings . 33
14 Lifting and carrying means . 33
14.1 General . 33
14.2 Requirement . 34
14.3 Test method . 34
15 Portable and hand-held assistive products or hand-held parts . 35
16 Static strength, impact and durability . 35
16.1 General . 35
16.2 Formulae for calculating forces . 35
16.3 Number of test cycles for durability . 38
16.4 Static strength . 39
16.5 Durability . 47
16.6 Impact . 55
17 Stability . 58
17.1 Requirements . 58
17.2 Test methods . 58
18 Surfaces, corners, edges and protruding parts . 59
19 Assistive products for children . 59
20 Forces in soft tissues of the human body . 59
21 Ergonomic principles . 59
22 Mobile assistive products . 60
22.1 General . 60
22.2 Immobilizing means . 60
22.3 Power-driven mobile assistive products . 61
22.4 Rough handling and movement . 61
22.5 Functional requirements for mobile assistive products . 62
22.6 Moving forces . 63
23 Fixed assistive products . 64
23.1 General . 64
23.2 Requirements . 64
23.3 Shower seats . 65
23.4 Bathing stretchers, shower tables and diaper changing tables . 66
23.5 Bath boards, back supports and seats . 67
23.6 Raised toilet seats . 68
23.7 Handrails, grab bars and handgrips. 69
23.8 Removable grab rails and handgrips . 71
23.9 Hinged rails and arm supports . 73
24 Portable assistive products . 74
24.1 General . 74
24.2 Stability and strength tests . 74
24.3 Raised toilet seats, detachable . 74
24.4 Toilet seats with built-in raising mechanism to help standing up and sitting down (non-
fixed) . 75
24.5 Bath boards, stools, back supports and seats . 75
24.6 Arm support, free-standing . 85
iv
25 Requirements for information supplied by the manufacturer . 86
25.1 General . 86
25.2 Instructions for use . 86
25.3 Labelling . 89
26 Packaging . 90
27 Test report . 90
Annex A (informative) Cognitive impairment . 91
Annex B (informative) General recommendations . 92
Annex C (informative) Environmental and consumer-related recommendations . 100
Annex D (informative) Periodic inspection . 105
Annex E (informative) Lithium batteries . 106
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 108
Bibliography . 110
v
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 173, Assistive products, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive products and
accessibility, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO 17966:2016), which has been technically
revised.
The main changes are as follows:
— new terms and definitions were added, and a few definitions updated (Clause 3(););
— new apparatus was added and a few updated (4.8(););
— requirements for flammability were updated, and requirements for other soft parts, polymeric parts and
wiring were added (5.2(););
— requirements for infection and microbiological contamination were updated, and requirements, test
methods, performance criteria and marking requirements for machine washable assistive products were
added (5.4(););
— requirements for electromagnetic compatibility were removed from this document, reference to
requirements in IEC 60601-1:2005 was added instead (Clause 7(););
— reference to electrical standards was adjusted, and requirements for electrical systems, safe positioning,
single fault safety, hold to run activation, emergency stopping functions and continuity of power supply
were therefore removed from this document (8.1(););
vi
— charge level indication for battery powered assistive products was modified for better understanding
(8.2(););
— requirement for ingress of particulate matter was specified (8.4.2(););
— requirement and test of pendant controls was added (8.5(););
— update of test method for velocity of powered lifting and lowering movement (11.4.2(););
— means to prevent falling out (e.g. side rails) were added (Clause 12(););
— Table 6 for calculating forces was updated, formula to find F1 was modified for several products and
drawing examples were given for explanation (16.2(););
— designed lifetime t was changed to expected lifetime t in the formula for calculating number of test
DL EL
cycles, expected lifetime was changed from a minimum of 3 years to 5 years, Table 7 and Table 8 were
updated (16.3(););
— modification of test methods and new test methods added for static strength (16.4()) and durability
(16.5(););
— modification of test methods for stability (Clause 17(););
— Clause 19 for assistive products for children has been modified;
— ergonomic requirement for surface of buttons from previous version were removed (Clause 21(););
— ergonomic requirement for hand-operated controls were adjusted to a height of 870 mm to 1 100 mm
above the surface of the floor (Clause 21(););
— test method for movement over a threshold and door frame were modified so it is no longer possible to
use a test dummy, and a reference to suitable loading pads was added (22.4.3, 22.4.4(, ););
— requirement for handles for pushing and pulling or both was changed to be positioned between 800 mm
to be operated at a height of 1 200 mm above the surface of the floor (22.5.2(););
— starting force in the requirements for moving forces was changed to maximum 170 N (22.6.1(););
— modification of test methods for fixed assistive products (Clause 23(););
— modification of test methods for portable assistive products (Clause 24(););
— Annex E on lithium batteries was added.
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.
vii
Introduction
This document specifies requirements and test methods that are relevant to assistive products for toileting,
bathing and showering.
Clauses 4 to 21 and Clauses 25 to 27 contain general requirements for all types of products included in the
scope.
Clauses 22 to 24 contain specific requirements for mobile, fixed and portable assistive products. These clauses
contain additional requirements to the requirement in Clauses 25 to 27.
An assistive product is deemed to conform with this document when it fulfils the general requirements as well
as the additional requirements in the clauses relevant to the type of product (mobile, fixed or portable).
In addition to the requirements in this document, Annex B gives general recommendations.
viii
Assistive products for toileting, bathing and showering —
Requirements and test methods
1 Scope
This document specifies requirements and associated test methods for assistive products for toileting, bathing
and showering (from herein referred to as ‘assistive product’ within this document).
NOTE 1 Some of the assistive products can be classified as medical devices.
This document specifies safety, functional and ergonomic requirements for both persons with disability and
assistants that apply during normal use and foreseeable misuse and failure.
This document specifies requirements and test methods for assistive products within the following divisions
of ISO 9999:2022.
09 12 03 Commode chairs;
chairs, with or without castors, with a collection receptacle used for toileting away from the
bathroom.
a
09 12 06 Toilets;
included are, e.g. raised or height adjustable toilets, toilets with built-in douche and air dryers.
a
09 12 09 Toilet seats;
devices attached to the toilet bowl or toilet chair for a person to sit on, which can provide
stability and comfort.
a
09 12 10 Toilet splash guards;
devices to keep bodily substances from splashing outside the toilet bowl.
09 12 12 Raised toilet seats, free-standing;
raised toilet seats (separate) standing on floor, where the seat can easily be removed from the
toilet bowl;
included are, e.g. over toilet frames.
09 12 15 Raised toilet seats, detachable;
raised toilet seats (loose attachments) placed directly on the toilet bowl/toilet seat where the
seat insert can easily be removed from the toilet bowl/toilet seat.
09 12 18 Raised toilet seats fixed to toilet;
devices permanently fixed on to a toilet bowl to increase the height of the seat and to facilitate
sitting down upon, and standing up from, the toilet;
included are, e.g. plinths.
09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
toilet seats that have a built-in lifting mechanism to assist a person to sit down on and get up
from the toilet.
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
devices mounted on the toilet that provide support getting on or off the toilet.
09 12 25 Toilet arm supports and toilet back supports, free standing.
a
09 12 36 Douches and air dryers for attachment to a toilet;
devices attached to a toilet to provide a water spray with or without air blowing afterwards to
wash, and possibly dry, a person’s bottom while sitting on the toilet;
included are, e.g. toilet seats with that function.
09 33 04 Bath boards;
seats without back support placed on the rim across the bathtub.
09 33 05 Bath seats;
seats hung from the rim of or placed in the bathtub;
included are e.g. bath seats with or without backrest.
09 33 07 Shower chairs with and without wheels;
devices for supporting sitting during showering;
included are, e.g. shower stools.
09 33 08 Back supports for bath or shower;
excluded are, e.g. back support cushions.
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
stationary or portable tables, with or without castors, on which a person lies during bathing,
showering or changing.
NOTE 2: Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered
by EN 12221-1.
a
09 33 15 Wash basins;
stationary or portable basins for water used when washing parts of the body.
a
09 33 18 Bidets;
stationary or portable basins primarily intended for washing genitals and bottom.
a
09 33 36 Assistive products for drying oneself;
devices and materials for enabling a person to dry their own body.
18 15 06 Height adjustable plinths and brackets;
height-adjustable surfaces or brackets on which furniture (e.g. wash basins) can be mounted.
18 18 03 Handrails and support rails;
bars, usually cylindrical, attached to a wall, floor or other stable structure that provide the
means for a person to support or stabilize themselves using hands or arms while walking, e.g. up
and down stairs or ramps or moving along corridors.
18 18 06 Fixed grab bars and handgrips;
devices, usually straight or angled bars, that are permanently attached to a wall, a wall and a
floor, or a wall, ceiling and floor to provide support to a person while standing or changing
position.
18 18 10 Removable grab rails and handgrips;
devices, usually straight or angled bars, that can be temporarily attached to walls, floors, ceilings
or furniture using, e.g. clamps or suction pads and removed without tools providing support to a
person while changing position.
18 18 11 Hinged rails and arm supports;
devices that provide support to a person when changing their position; they can be fixed to a
wall or floor and can be folded up or sideways or lowered down to allow access or when they
are not needed.
a
There are no specific requirements and test methods for these products. Only the relevant general
requirements apply when these products are considered to be assistive products.
This document does not apply for:
— safe mounting in building structures;
— fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to
excretion-disposal and wrapping systems;
— bathtub hoists that are covered by ISO 10535:2021, namely
— 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats;
— 12 36 09 Mobile hoists for transferring a person in lying position;
— 12 36 12 Stationary hoists fixed to walls, floor or ceiling;
— 12 36 15 Stationary hoists fixed to, or mounted in or on, another product;
— 09 33 21 Bathtubs;
— stability and friction issues in relation to slippery surfaces due to soap;
— products that have been customised or custom-made for an individual user.
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 845:2006, Cellular plastics and rubbers — Determination of apparent density
ISO 2439:2008, Flexible cellular polymeric materials — Determination of hardness (indentation technique)
ISO 3746:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
ISO 10993-1:2025, Biological evaluation of medical devices — Part 1: Requirements and general principles for
the evaluation of biological safety within a risk management process
ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
1)
ISO 14155:20202025, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2019, Medical devices — Application of risk management to medical devices
1)
Fourth edition under preparation. Stage at the time of publication: ISO/FDIS 14155.
ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the
manufacturer — Part 1: General requirements
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 22442-1:2020, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
IEC 60068-2-31:2008, Environmental testing — Part 2‑31: Tests — Test Ec: Rough handling shocks, primarily
for equipment‑type specimens
IEC 60332-1-2:2025, Tests on electric and optical fibre cables under fire conditions — Part 1‑2: Test for vertical
flame propagation for a single insulated wire or cable ‑ Procedure for 1 kW pre‑mixed flame
IEC 60529:1989+AMD2:2013+COR1:2019, Degrees of protection provided by enclosures (IP code)
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
IEC 60601-1-11:2015+AMD1:2020, Medical electrical equipment — Part 1‑11: General requirements for basic
safety and essential performance ‑ Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
IEC 60601-2-35:2020, Medical electrical equipment — Part 2‑35: Particular requirements for the basic safety
and essential performance of heating devices using blankets, pads, and mattresses and intended for heating in
medical use
IEC 60695-11-10:2013+COR1:2014, Fire hazard testing — Part 11‑10: Test flames — 50 W horizontal and
vertical flame test methods
EN 614-1:2006+A1:2009, Safety of machinery ‑ Ergonomic design principles ‑ Part 1: Terminology and general
principles
EN 12527:1998, Castors and wheels ‑ Test methods and apparatus
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-
1:2005+AMD1:2012+AMD2:2020 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/
3.1
applied part
part of device that in normal use (3.17()) necessarily comes into physical contact with the user (3.27()) to
perform its function
3.2
assistant
person who is helping or supporting a person with disability in using the assistive product (3.3())
Note 1 to entry: Examples of the ways assistants help persons with disability are pushing commode chairs, operating
height adjustable devices, and assisting with entering and leaving seats, stretchers and commode chairs.
Note 2 to entry: An assistant can be a health care professional or a non-professional, for example, a relative.
3.3
assistive product
product that optimizes a person’s functioning and reduces disability
Note 1 to entry: See Clause B.2.
Note 2 to entry: Assistive products include devices, instruments, equipment, and software.
Note 3 to entry: Assistive products can be specially produced or generally available items.
[SOURCE: ISO 9999:2022, 3.3]
3.3.1
fixed assistive product
product designed to be fastened to a support or otherwise secured in a specific location either by shape or
fasteners
Note 1 to entry: Friction bath boards and friction toilet seats are excluded from this definition.
3.3.2
mobile assistive product
movable mobile assistive product
equipment that, once installed and placed into service, is intended to be moved from one location to another
while supported by its own wheels or equivalent means
3.3.3
portable assistive product
movable portable assistive product
equipment that, once installed and placed into service, is intended to be used with a user in place only when
stationary and can be moved from one location to another without the user in place
Note 1 to entry: Bath boards and toilet seats secured by friction are included.
3.3.4
robotic assistive product
assistive product (3.3()) that has programmed actuated mechanisms with a degree of autonomy to perform
locomotion, manipulation or positioning
3.4
backward
180° to the forward direction of travel
3.5
cleaning
removal of foreign materials from a surface
3.6
detachable part
part designed to be unfastened or disconnected without damage to the part or the product
[SOURCE: ISO 20342-1:2022, 3.10, modified — “whole” was changed to “product”.]
3.7
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined
purpose
[SOURCE: ISO 11139:2018, 3.84]
3.8
environment
surrounding in which an assistive product (3.3()) can be used
3.8.1
home care environment
a domestic area where the assistive product (3.3()) is used to alleviate or compensate for an injury, disability
or disease
3.8.2
public area
surroundings that are available for everyone
EXAMPLE Areas used for swimming, public restrooms.
3.9
forward
intended direction of travel, as indicated by the manufacturer in the instructions for use
3.10
foreseeable misuse
wrongful use which can be reasonably anticipated
3.11
intended performance
functional characteristics of a product, process or service, as intended by the manufacturer according to the
given specifications, instructions and information
Note 1 to entry: They can include, but are not limited to, strength, durability, stability, noise and vibration, application of
use and conditions of use.
3.12
intended purpose
function that a product, process or service has, as intended by the manufacturer according to the given
specifications, instructions and information
Note 1 to entry: Adapted from ISO 14971:2019, 3.6.
3.13
intended use
act of using a product, process or service as intended by the manufacturer according to the given
specifications, instructions and information
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with,
user profile, use environment, and operating principles are typical elements of the intended use.
Note 2 to entry: Adapted from ISO 14971:2019, 3.6.
3.14
lay user
individual who does not have formal education in a relevant field of healthcare or medical discipline
[SOURCE: ISO 18113-1:2022, 3.1.40, modified — The preferred term “lay person” was removed; the example
and notes to entry were deleted.]
3.15
load and mass
3.15.1
maximum user mass
greatest permissible weight of the user (3.27(),), specified by the manufacturer, intended to be supported by
the assistive product (3.3())
3.15.2
minimum user mass
lowest possible weight of the user (3.27(),), specified by the manufacturer, needed for activating or using an
assistive product (3.3())
3.15.3
maximum load
safe working load
greatest permissible weight on equipment or an equipment part during normal use (3.17())
Note 1 to entry: Depending on the type of assistive product, the maximum load can be either higher or lower than the
user mass. In case of a product intended to carry both a user and an assistant and possibly accessories and other external
load, such as water, the maximum load will be higher than the maximum user mass. In case of a product intended for the
user to (just) lean on for support, the maximum user mass will be higher than the maximum load.
Note 2 to entry: Adapted from IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.109.
3.16
mechanism
system of parts working together
3.17
normal use
use of a product, process or service in accordance with the specifications, instructions and information
provided by the manufacturer, not only intended for medical use but also maintenance, service, transport, etc.
Note 1 to entry: Normal use should not be confused with intended use (3.13().). While both include the concept of use as
intended by the manufacturer, intended use focuses on the intended purpose (3.12()) while normal use incorporates not
only the intended purpose, but maintenance, service, transport, etc. as well.
3.18
operator
())
person handling the assistive product (3.3
Note 1 to entry: It can be the person with disability, an assistant or any other person who comes in contact with the
product, e.g. a janitor.
3.19
pendant control
hand-held device, which has a functional connection to the assistive product (3.3(),), to control function(s) of
the product, e.g. articulations and movements
Note 1 to entry: Pendant controls can be wired or wireless, and can integrate other functions, (e.g. communications,
radio/TV).
[SOURCE: IEC 60601-2-52:2009, 201.3.214, modified — “medical bed” replaced with “assistive product”,
“controlling at least medical bed” replaced with “to control function(s) of the product, e.g.”.]
3.20
permanent deformation
alteration in shape or structure of a previously normally formed part that will stay altered as the test is
completed
3.21
risk
combination of the probability of occurrence of harm and the severity of that harm
3.22
side rail
physical barrier, which can be a detachable accessory or integral to the overall construction of an assistive
product (3.3())and is mounted to the side(s) of an assistive product
Note 1 to entry: When a side rail is closed/fully raised, it provides a physical barrier, which is intended to reduce the risk
of the person with disability accidentally slipping or rolling off the lying support surface.
[SOURCE: ISO 21856:2022, 3.28, modified — In Note 1 to entry, “user” was replaced with “person with
disability”.]
3.23
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
Note 1 to entry: In this document, a single fault includes an error of the software.
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.116, modified — Note 1 to entry was added.]
3.24
single patient multiple use
intended by the manufacturer to be reused on an individual patient for multiple uses
Note 1 to entry: A single patient multiple use medical device or accessory can require processing between uses.
[SOURCE: ISO 20417:2021, 3.25, modified — Note 2 to entry was deleted.]
3.25
single use
do not re-use
use only once
intended by the manufacturer to be used on an individual patient or specimen during a single procedure and
then disposed of
Note 1 to entry: A single use medical device or accessory is not intended by the manufacturer to be further processed and
used again.
[SOURCE: ISO 20417:2021 3.26]
3.26
test cycle
full cycle for the intended action
3.27
user
person who is lying, sitting or leaning on the product
Note 1 to entry: The user can be either the person with disability or an assistant.
4 General requirements
4.1 General
In order for a product to conform with this document, all relevant clauses, depending on the type of product,
shall be fulfilled.
4.2 Risk analysis
The safety of an assistive product shall be assessed by identifying hazards and estimating the risks associated
with them using the procedures specified in ISO 14971:2019 and, if relevant, ISO 12100:2010.
When an assistive product is intended by the manufacturer to be used in combination with a device that is not
a medical device, the resulting combination of the assistive product and device shall behave in a safe way as a
system.
Risk management shall include all involved persons in normal use, and third persons (e.g. a child) in the
surrounding coming into contact with the assistive product. This also includes considerations in respect to lay
users.
NOTE In the case of certain disabilities there can be a need for higher levels of safety for equipment used to offset
the effects of that disability.
4.3 Intended performance
An assistive product shall have suff
...
PROJET
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ISO/DIS 17966
ISO/TC 173
Produits d’assistance pour les
Secrétariat: SIS
toilettes, le bain et la douche —
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Exigences et méthodes d’essai
2024-11-04
Assistive products for toileting, bathing and showering —
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Requirements and test methods
2025-01-27
ICS: 11.180.99; 11.180.01
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ISO/DIS 17966:2024(fr)
Sommaire Page
Avant-propos .viii
Introduction . ix
1 Domaine d’application . 1
2 Références normatives . 4
3 Termes et définitions . 6
4 Prescriptions générales et méthodes d’essai . 10
4.1 Analyse du risque. 10
4.2 Performances prévues . 11
4.3 Évaluation et investigation cliniques . 11
4.4 Produits d’assistance pour l’hygiène personnelle démontables . 11
4.5 Éléments de fixation . 11
4.6 Masse de l’utilisateur/limites de charge . 11
4.7 Appareillage . 12
4.7.1 Application d’une force . 12
4.7.2 Mesurage de la force . 12
4.7.3 Mesurage de la distance . 12
4.7.4 Mesurage des angles . 12
4.7.5 Mesurage du couple . 12
4.7.6 Mesurage des niveaux de pression acoustique . 12
4.7.7 Plan d’essai . 12
4.7.8 Butées . 12
4.7.9 Boîte . 13
4.7.10 Équipement pour l’application de charges . 13
4.7.11 Équipement de mesure de la pression de l’eau, de l’huile et de l’air . 13
4.7.12 Patins de chargement . 13
4.7.13 Équipement pour l’essai de choc . 17
4.7.14 Supports d’appui . 21
4.7.15 Cylindre pour petits éléments . 21
4.7.16 Obstacle . 22
4.7.17 Obstacle vertical en bois dur . 22
4.8 Conditions d’essai . 22
5 Matériaux . 22
5.1 Généralités . 22
5.2 Inflammabilité . 22
5.2.1 Généralités . 22
5.2.2 Parties rembourrées . 23
5.2.3 Autres parties souples . 23
5.2.4 Parties polymériques . 24
5.2.5 Câblage . 24
5.3 Biocompatibilité et toxicité . 24
5.4 Infection et contamination microbiologique . 24
5.4.1 Nettoyage et désinfection. 24
5.4.2 Tissus animaux . 25
5.5 Résistance à la corrosion . 25
6 Émissions sonores et vibrations . 26
6.1 Bruit et vibration . 26
6.2 Niveaux de pression acoustique et fréquences des dispositifs d’avertissement sonore . 26
iii
ISO/DIS 17966:2024(fr)
7 Compatibilité électromagnétique . 26
8 Sécurité électrique . 26
8.1 Généralités . 26
8.2 Produits d’assistance alimentés par batterie - indicateur du niveau de charge. 27
8.3 Couvertures chauffantes électriques, coussinets et appareils chauffants flexibles de nature
similaire . 27
8.4 Pénétration de liquides ou de particules . 27
8.4.1 Pénétration de liquides . 27
8.4.2 Pénétration de particules . 28
8.5 Commandes mobiles . 28
9 Trop-plein, fuite et pénétration de liquides . 28
9.1 Pénétration de liquides . 28
9.1.1 Exigences . 28
9.1.2 Méthode d’essai . 28
9.2 Trop-plein et fuite. 29
9.2.1 Généralités . 29
9.2.2 Substances pouvant provenir d’une fuite du produit d’assistance pendant l’utilisation prévue
ou en cas de condition de défaut . 29
10 Températures des parties entrant en contact avec la peau humaine . 29
11 Sécurité des parties mobiles et articulées . 30
11.1 Parties mobiles . 30
11.2 Parties pliables . 31
11.3 Vitesse des mouvements de levage et d’abaissement motorisés . 31
11.3.1 Exigences . 31
11.3.2 Méthode d’essai . 32
11.4 Usure mécanique . 32
11.5 Zones de piégeage pour les pieds en ce qui concerne les parties mobiles . 32
12 Moyens de prévention des chutes . 33
12.1 Généralités . 33
12.2 Barrières latérales pour protéger contre les chutes accidentelles de l’utilisateur . 33
13 Prévention des pièges de certaines parties du corps humain . 35
13.1 Trous et espaces . 35
13.2 Ouvertures en forme de V . 35
14 Mécanismes de pliage et de réglage . 36
14.1 Généralités . 36
14.2 Mécanismes de verrouillage . 36
15 Moyens de levage et de portage . 36
15.1 Généralités . 36
15.2 Exigence . 36
15.3 Méthode d’essai . 37
16 Produits d’assistance portable ou tenus à la main ou parties tenues à la main . 38
17 Résistance statique, résistance aux chocs et durabilité. 38
17.1 Généralités . 38
17.2 Formules . 39
17.2.1 Formules pour calculer les forces . 39
17.3 Nombre de cycles d’essai pour la durabilité . 42
17.4 Résistance statique . 44
17.4.1 Exigences . 44
iv
ISO/DIS 17966:2024(fr)
17.4.2 Méthodes d’essai . 44
17.5 Durabilité . 50
17.5.1 Exigences . 50
17.5.2 Méthodes d’essai . 51
17.6 Impact . Error! Bookmark not defined.
17.6.1 Exigences . 58
17.6.2 Méthodes d’essai . 58
18 Stabilité . 61
18.1 Exigences . 61
18.2 Méthodes d’essai . 61
19 Surfaces, coins, arêtes et parties saillantes . 62
20 Produits d’assistance pour enfants . 62
21 Forces sur les tissus mous du corps humain . 62
22 Principes ergonomiques . 62
23 Produits d’assistance mobiles . 63
23.1 Généralités . 63
23.2 Moyens d’immobilisation . 63
23.2.1 Généralités . 63
23.2.2 Exigences relatives aux dispositifs de verrouillage . 64
23.2.3 Méthodes d’essai des dispositifs de verrouillage . 64
23.2.4 Méthodes d’essai de la durabilité des freins . 64
23.2.5 Frein actionné par un levier . 64
23.3 Sécurité électrique des produits d’assistance mobiles . 64
23.3.1 Produits d’assistance mobiles motorisés . 64
23.4 Manipulation et mouvements brusques . 64
23.4.1 Généralités . 64
23.4.2 Exigences . 65
23.4.3 Méthode d’essai pour le franchissement d’un seuil . 65
23.4.4 Méthode d’essai pour l’impact de cadre de porte . 65
23.5 Exigences fonctionnelles pour les produits d’assistance mobiles . 66
23.5.1 Repose-pieds . 66
23.5.2 Position des poignées/boutons de poussée . 66
23.5.3 Diamètre de giration des produits d’assistance mobiles . 66
23.6 Forces de déplacement . 66
23.6.1 Exigences relatives aux forces de déplacement . 66
23.6.2 Méthodes d’essai des forces de déplacement . 67
24 Produits d’assistance fixes . 67
24.1 Généralités . 67
24.2 Exigences . 68
24.3 Sièges de douche . 68
24.3.1 Description . 68
24.3.2 Méthodes d’essai . 68
24.4 Brancards pour le bain, tables de douche et tables à langer . 70
24.4.1 Description . 70
24.4.2 Méthodes d’essai . 70
24.5 Planches pour le bain, supports dorsaux et sièges . 70
24.5.1 Description . 70
24.5.2 Méthode d’essai concernant la durabilité . 71
24.6 Surélévateurs de WC . 71
24.6.1 Description . 71
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ISO/DIS 17966:2024(fr)
24.6.2 Exigences . 71
24.6.3 Méthodes d’essai . 72
24.7 Mains courantes, barres et poignées d’appui . 73
24.7.1 Description . 73
24.7.2 Principes ergonomiques . 73
24.7.3 Méthodes d’essai . 73
24.8 Barres et poignées d’appui amovibles . 74
24.8.1 Description . 74
24.8.2 Principes ergonomiques . 75
24.8.3 Méthodes d’essai . 75
24.9 Barres et supports de bras articulés . 76
24.9.1 Description . 76
24.9.2 Généralités . 76
24.9.3 Méthodes d’essai . 76
25 Produits d’assistance portables . 77
25.1 Généralités . 77
25.2 Essais de stabilité et de résistance . 77
25.3 Surélévateurs de WC, amovibles . 78
25.3.1 Description . 78
25.3.2 Exigences . 78
25.4 Cuvettes de WC avec un mécanisme de levage incorporé pour aider à s’asseoir et à se lever
(non fixé) . 78
25.4.1 Description . 78
25.4.2 Durabilité . 78
25.5 Planches pour le bain, tabourets, supports dorsaux et sièges . 78
25.5.1 Description . 78
25.5.2 Matériaux . 78
25.5.3 Stabilité . 78
25.5.4 Essais de stabilité des produits d’assistance conçus pour être soutenus par les rebords
d’une baignoire . 79
25.5.5 Essai de résistance des supports . 83
25.5.6 Essai de frottement de la planche pour le bain/siège de bain . 85
25.5.7 Essai de force horizontale statique sur la poignée . 86
25.5.8 Essai de force verticale statique de la poignée . 87
25.6 Supports de bras, autoportant . 88
25.6.1 Exigences . 88
25.6.2 Méthodes d’essai . 88
26 Exigences relatives aux informations fournies par le fabricant . 88
26.1 Généralités . 88
26.2 Instructions d’utilisation. 89
26.2.1 Généralités . 89
26.2.2 Informations de prévente . 89
26.2.3 Information des utilisateurs . 90
26.2.4 Informations relatives à l’entretien . 91
26.3 Étiquetage . 92
27 Emballage . 93
28 Rapport d’essai . 93
Annexe A (informative) Déficience cognitive . 94
Annexe B (informative) Recommandations générales. 95
Annexe C (informative) Exigences environnementales et exigences relatives au consommateur . 104
vi
ISO/DIS 17966:2024(fr)
Annexe D (informative) Inspection périodique . 110
Annexe E (informative) Batteries au lithium . 111
Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences générales
en matière de sécurité et de performances concernées du Règlement (UE) 2017/745 . 113
Bibliographie . 117
vii
ISO/DIS 17966:2024(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux de
normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général confiée
aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non gouvernementales,
en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec la Commission
électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont décrites
dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents critères
d’approbation requis pour les différents types de documents ISO. Le présent document a été rédigé
conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité de
tout droit de propriété revendiqué à cet égard. À la date de publication du présent document, l’ISO n’avait pas
reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il y a lieu d’avertir les responsables de la mise en application du présent document que des informations plus
récentes sont susceptibles de figurer dans la base de données de brevets, disponible à l’adresse
www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou partie
de tels droits de propriété.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions spécifiques
de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de l’ISO aux principes
de l’Organisation mondiale du commerce (OMC) concernant les obstacles techniques au commerce (OTC),
voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 173, Produits d’assistance, en collaboration
avec le groupe de travail ISO/TC 173/WG 9, Produits d’assistance destinés à l’hygiène personnelle.
Il est prévu que le présent document soit adopté comme Norme EN ISO par le comité technique CEN/TC 293,
Aides techniques pour personnes handicapées pour donner suite à la demande de normalisation M/575
adressée au CEN par la Commission européenne et l’Association européenne de libre-échange et dans
le respect des exigences essentielles du Règlement (UE) 2017/745 du 5 avril 2017 relatif aux dispositifs
médicaux. Par conséquent, le document n’utilise que des références datées.
La présente seconde édition de l’ISO 17966 remplace l’ISO 17966:2016. Cependant, compte-tenu des
modifications techniques et des exigences supplémentaires apportées au présent document comparé
à l’ISO 17966:2016, une période de transition de 24 mois pour se conformer au présent document est
recommandée.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www.iso.org/fr/members.html.
viii
ISO/DIS 17966:2024(fr)
Introduction
Le présent document spécifie les exigences et méthodes d’essai qui s’appliquent aux produits d’assistance
pour les toilettes, le bain et la douche.
Des exigences générales relatives à tous les types de produits qui entrent dans le Domaine d’application sont
énoncées de l’Article 4 à l’Article 22 et de l’Article 26 à l’Article 28.
Des exigences spécifiques relatives aux produits mobiles, fixes et portables sont énoncées de l’Article 23
à l’Article 25. Ces articles mentionnent des exigences supplémentaires qui complètent les articles relatifs
aux exigences générales.
Afin de revendiquer la conformité d’un produit au présent document, il est nécessaire que toutes les dispositions
applicables soient satisfaites, selon le type de produit considéré. Par exemple, certains produits ne contiennent
pas de composants électriques ; par conséquent, il est admis que les dispositions relatives aux composants
électriques ne s’appliquent pas.
Outre les exigences du présent document, l’Annexe B fournit des recommandations générales.
ix
PROJET DE NORME INTERNATIONALE ISO/DIS 17966:2024(fr)
Produits d’assistance pour les toilettes, le bain et la douche —
Exigences et méthodes d’essai
1 Domaine d’application
Le présent document spécifie des exigences et méthodes d’essai associées pour les produits d’assistance
pour les toilettes, le bain et la douche (dès à présent et tout au long de la norme désignés sous le terme de
« produit d’assistance »), lesquels sont considérés comme des dispositifs médicaux conçus par le fabricant
dans le but de soulager ou compenser un handicap.
NOTE 1 Les produits d’assistance sont considérés comme des dispositifs médicaux dans certaines régions, mais pas
dans d’autres.
La norme spécifie des exigences de sécurité, de fonctionnalité et d’ergonomie pour les personnes en situation
de handicap mais également pour les accompagnants et elles s’appliquent lors d’une utilisation normale,
d’une mauvaise utilisation prévisible et d’une défaillance.
Le présent document spécifie des exigences et des méthodes d’essai pour les produits d’assistance entrant
dans le cadre des divisions suivantes de l’EN ISO 9999:2022.
Il n’existe aucune exigence et aucune méthode d’essai spécifique pour les produits marqués d’un astérisque (*).
Les exigences générales appropriées ne s’appliquent que lorsque ces produits sont considérés comme des
dispositifs médicaux.
09 12 03 Chaises percées ;
Sièges, avec ou sans roulettes, avec un seau hygiénique utilisés hors des toilettes.
09 12 06 Toilettes ;*
Les cuvettes surélevées ou réglables en hauteur et celles avec douchette incorporée et séchoir à air
chaud, par exemple, en font partie.
09 12 09 Abattants de WC ;*
Dispositifs attachés à la cuvette de WC ou au siège des toilettes sur lesquels l’usager est assis ;
ils peuvent apporter de la stabilité et du confort.
09 12 10 Pare-éclaboussures de WC ;*
Dispositifs permettant d’éviter que les substances corporelles ne se répandent hors de la cuvette de WC.
09 12 12 Surélévateurs de WC, non montés sur les WC
Surélévateurs (séparés) avec appui au sol ; le siège peut facilement être enlevé de la cuvette de WC.
Les cadres sur WC, par exemple, en font partie.
ISO/DIS 17966:2024(fr)
09 12 15 Surélévateurs de WC, amovibles ;
Surélévateurs de WC (avec fixations rapportées) posés directement sur la cuvette/le siège des WC.
Le surélévateur de WC peut être retiré facilement de la cuvette/du siège des WC.
09 12 18 Surélévateurs de WC fixés sur les WC ;
Dispositifs fixés en permanence sur la cuvette des WC pour augmenter la hauteur d’assise et
permettre de s’asseoir et de se lever plus facilement des toilettes.
Les surélévations maçonnées, par exemple, en font partie.
09 12 21 Cuvettes de WC avec un mécanisme de levage incorporé pour aider à s’asseoir et à se lever ;
Cuvettes de WC avec un mécanisme de levage incorporé permettant d’aider une personne à s’asseoir
et à se lever des toilettes.
09 12 24 Supports de bras et supports dorsaux montés sur les WC ;
Dispositifs montés sur la cuvette des WC fournissant un support pour s’asseoir sur ou se lever des
toilettes.
09 12 25 Supports de bras et supports dorsaux non montés sur les WC ;
09 12 36 Douchettes et séchoirs à air chaud adaptables aux toilettes ;*
Dispositifs attachés à une cuvette de WC fournissant un jet d’eau avec ou sans souffle d’air,
permettant à une personne étant assise sur les WC de se lav
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