oSIST prEN ISO 17966:2025

Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/DIS 17966:2024)

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

Hilfsmittel zum Toilettengang, Baden und Duschen - Anforderungen und Prüfverfahren (ISO/DIS 17966:2024)

Produits d’assistance pour les toilettes, le bain et la douche - Exigences et méthodes d’essai (ISO/DIS 17966:2024)

Pripomočki za stranišče, kopanje in prhanje - Zahteve in preskusne metode (ISO/DIS 17966:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 26-Jan-2025
• ICS: 11.180.01 - Aids for disabled and handicapped persons in general
• ICS: 11.180.99 - Other standards related to aids for disabled and handicapped people
• ICS: 91.140.70 - Sanitary installations
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 14-Nov-2024
• Due Date: 03-Apr-2025
• Completion Date: 03-Feb-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: prEN ISO 17966 - Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/DIS 17966:2024)

Overview

The oSIST prEN ISO 17966:2025 standard, titled Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/DIS 17966:2024), is a comprehensive document developed by CEN. This standard establishes essential requirements and associated test methods for assistive products designed to aid individuals with disabilities during toileting, bathing, and showering activities. These products, classified in some jurisdictions as medical devices, aim to alleviate or compensate for disability, enhancing user safety, comfort, and independence.

The standard covers a wide range of assistive products classified under various sections of ISO 9999, including commode chairs, toilet seats with raising mechanisms, bath seats, shower chairs, grab rails, and more. It addresses both user and assistant safety, ensuring products perform reliably during normal use as well as foreseeable misuse or failure. The standard also defines test methods to measure operational forces, mechanical safety, biocompatibility, electrical safety, and environmental resistance, among others.

Key Topics

• Scope and Classification
  This standard applies to assistive products for personal hygiene listed under specific ISO 9999 codes. It excludes custom-made products, fixed building installations, bathtub hoists (covered by ISO 10535), and mainstream diaper-changing tables (covered by EN 12221).

• Safety and Performance Requirements
  It specifies critical safety criteria during both typical and foreseeable misuse conditions. These include resistance to mechanical wear, prevention of fall hazards through side rails or supports, safe folding and moving parts, and avoidance of trapping zones.

• Test Methods
  The document defines detailed procedures and apparatus for measuring:

  • Forces necessary to operate controls
  • Sound and vibration levels
  • Electrical safety parameters such as ingress protection and battery indicators
  • Material properties including flammability, biocompatibility, and corrosion resistance

• Work Environment Safety
  Requirements also consider the safety of caregivers and assistants, addressing ergonomic factors and workplace hazards related to the use of assistive devices.

• Material and Hygiene Standards
  Materials used must meet strict criteria for biocompatibility, toxicity, and resistance to microbiological contamination. Cleaning and disinfecting methods are detailed to ensure infection control.

Applications

oSIST prEN ISO 17966:2025 is vital for manufacturers, healthcare providers, regulators, and designers involved in the development, certification, and use of assistive toileting, bathing, and showering products. Applications include:

• Product Development
  Guiding design and engineering efforts to meet international safety and performance benchmarks.

• Quality Assurance
  Establishing testing protocols for new products to verify compliance with safety, durability, and usability standards.

• Regulatory Compliance
  Supporting medical device approvals by aligning product claims and safety data with recognized international standards.

• Healthcare Settings
  Ensuring assistive devices used in hospitals, care homes, and home care improve user independence while minimizing risks to users and caregivers.

• Accessibility Solutions
  Promoting inclusive design in sanitation facilities, public restrooms, and residential bathrooms to accommodate persons with disabilities.

Related Standards

• ISO 9999 - Classification of assistive products for persons with disability
• ISO 10535 - Hoists for bathing applications
• EN 12221-1 and EN 12221-2 - Diaper-changing tables for babies and toddlers
• EN 14688 - General requirements for wash basins
• ISO 7176 series - Wheelchairs and related assistive technologies

Understanding and applying oSIST prEN ISO 17966:2025 alongside these complementary standards ensures a holistic approach to the development and implementation of safe, effective assistive products for toileting, bathing, and showering. This enables enhanced quality of life for users and fosters uniform international regulatory frameworks.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2025
Pripomočki za stranišče, kopanje in prhanje - Zahteve in preskusne metode
(ISO/DIS 17966:2024)
Assistive products for toileting, bathing and showering - Requirements and test methods
(ISO/DIS 17966:2024)
Hilfsmittel zum Toilettengang, Baden und Duschen - Anforderungen und Prüfverfahren
(ISO/DIS 17966:2024)
Produits d’assistance pour les toilettes, le bain et la douche - Exigences et méthodes
d’essai (ISO/DIS 17966:2024)
Ta slovenski standard je istoveten z: prEN ISO 17966
ICS:
11.180.01 Pripomočki za Aids for disabled and
onesposobljene in handicapped persons in
hendikepirane osebe na general
splošno
91.140.70 Sanitarne naprave Sanitary installations
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
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
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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
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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 doc
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