FprEN ISO 17966
(Main)Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/FDIS 17966:2026)
- 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
- Publication Date
- 22-Dec-2026
- Technical Committee
- CEN/TC 293 - Technical aids for disabled persons
- Drafting Committee
- CEN/TC 293 - Technical aids for disabled persons
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 22-Sep-2026
- Due Date
- 11-Apr-2025
- Completion Date
- 22-Sep-2026
FprEN ISO 17966 is a CEN draft European standard for assistive products for toileting, bathing and showering. It specifies safety, functional, ergonomic requirements and test methods for products intended by the manufacturer to alleviate or compensate for disability, and it also takes assistants into account where their use is part of normal operation.
In practice, FprEN ISO 17966 is the document used to design, test and describe commode chairs, toilet seats, shower chairs, bath boards, grab rails and related products. It covers normal use, foreseeable misuse and failure, and it includes both general requirements and product-specific test methods.
What does FprEN ISO 17966 specify?
FprEN ISO 17966 specifies requirements and associated test methods for assistive products for toileting, bathing and showering that are treated as medical devices in some jurisdictions. It also sets out requirements for safety, performance, ergonomics and the work environment and safety of assistants.
The document is organized into a general part and product-specific clauses, followed by information, packaging and reporting requirements. The main structure runs from Scope and Normative references through Terms and definitions, then general requirements, materials, noise, electromagnetic compatibility, electrical safety, liquid ingress, temperature, moving parts, fall prevention, entrapment prevention, lifting, strength, stability, ergonomics, mobile products, fixed products, portable products, manufacturer information, packaging and test reporting.
Annexes give guidance and special topics used alongside the main requirements.
| Annex | What it covers |
|---|---|
| Annex A | Cognitive impairment |
| Annex B | General recommendations |
| Annex C | Environmental and consumer-related requirements |
| Annex D | Periodic inspection |
| Annex E | Lithium batteries |
| Annex ZA | Relationship with Regulation (EU) 2017/745 General Safety and Performance Requirements |
The scope names product families from EN ISO 9999:2022 such as commode chairs, toilets, toilet seats, raised toilet seats, bath boards, bath seats, shower chairs, bathing stretchers, wash basins, bidets, handrails and grab rails. It also states exclusions for building structure fixing, fixed building utilities and some other product types.
What are the key requirements of FprEN ISO 17966?
FprEN ISO 17966 combines risk management, clinical evaluation, mechanical safety and user information. The most important requirements are the ones that decide whether a product is safe to use, whether it can carry the intended load and whether the manufacturer has documented that use clearly.
Risk, intended performance and clinical evidence
Clause 4.1 requires risk analysis using EN ISO 14971 and, where relevant, EN ISO 12100. The analysis has to consider users, assistants and third persons around the product. In practice, this means the manufacturer must identify hazards from normal use, foreseeable misuse and failure before the product is released.
Clause 4.2 requires intended performance to be backed by sufficient strength and durability, supported as appropriate by literature, calculations and test results. That matters because the manufacturer has to state what the product is for, what loads it can handle and under which conditions it remains fit for use.
Clause 4.3 requires a clinical evaluation for all assistive products, and any clinical investigation has to follow EN ISO 14155. For buyers and quality teams, that means clinical justification is part of the conformity picture, not an optional extra.
Dismantling, fasteners and load limits
Clauses 4.4 and 4.5 address products that can be dismantled for storage, transport or cleaning. Reassembly must not create an unacceptable risk, and load-bearing fasteners must not be single-use fasteners. In practice, products that come apart for cleaning or transport need a design that still locks together safely after repeated assembly.
Clause 4.6 requires declaration of maximum user mass, and maximum load where it differs, plus minimum user mass where needed for function. Products intended to support a seated or lying user must support at least 100 kg body mass. This is a practical design and purchasing point: the stated load rating has to match the intended user group, and the product must be visibly limited if it is meant for lower body masses.
Materials, hygiene, corrosion and sound
Clause 5 requires material suitability, including biocompatibility assessment for body-contacting materials using EN ISO 10993-1. It also asks the manufacturer to reduce risks from substances that may leak from the product, including substances of very high concern, and to consider cleaning, disinfection and corrosion.
Clause 5.5 requires corrosion risk assessment and allows salt spray testing to EN ISO 9227 when corrosion is a safety risk. That matters for products used in wet bathroom environments, where corrosion can affect strength, movement or hygiene.
Clause 6 covers noise and vibration. If noise is not part of intended performance, it must still be considered as a hazard or nuisance, and noise measurements for powered products are taken using EN ISO 3746. Audible warning devices also have frequency and sound-level expectations. For users with hearing loss, this affects whether alarms are actually noticeable.
Electrical safety, liquid ingress and temperature
Clause 7 requires electromagnetic compatibility (EMC) for products with electrical or electronic parts. Clause 8 applies electrical safety requirements, including home healthcare use where relevant, battery charge indication when safety depends on internal power, and specific requirements for pendant controls and heated flexible appliances.
Clauses 8 and 9 also address ingress of liquids and particulate matter, overflow and leakage. Bathroom products often operate near water, so the standard asks the manufacturer to control the risk that liquid entry or leakage creates a hazard.
Clause 10 sets surface-temperature control for parts that touch human skin. The product has to be assessed for ambient conditions, fault conditions and contact duration. If surfaces may become hot, the manufacturer may need warnings and precautions in the instructions for use.
Moving parts, entrapment and fall prevention
Clauses 11, 12, 13 and 14 cover moving parts, folding parts, trapping zones, side rails and locking mechanisms. The product must avoid finger, foot, head and genital entrapment, either by guards or by maintaining safe gaps. Folding and adjusting mechanisms must lock securely and resist unintended release.
Clause 12 requires measures to prevent the user falling out where that risk exists. For lying support surfaces, side rail height depends on whether the patient is left unattended. Clause 13 requires safe clearances for holes and stationary gaps, and the user group has to be specified so the correct distances are applied.
Lifting, handling, drops and durability
Clauses 15 and 16 address lifting and carrying means, and portable or hand-held products or parts. Handles and grips must withstand a defined force test, and portable items must survive free-fall testing from a height based on mass. That matters for transport, installation and day-to-day handling by carers.
Clause 17 is the main mechanical strength section. It covers static strength, durability and impact, gives formulae for calculating test forces, sets the number of durability cycles from expected lifetime, and provides product-specific load and impact methods. For procurement and quality control, this clause is where product robustness is verified.
Clause 18 tests stability of mobile and portable products at forward, backward and sideward tilt angles under maximum load. Clauses 19 and 20 deal with smooth surfaces, protruding parts and choking hazards for children. Clause 21 requires the risk from forces in soft tissues of the human body to be assessed, which is relevant to pressure and discomfort risks.
Ergonomics, mobility and fixed or portable product families
Clause 22 gives ergonomic requirements for handles, pedals and controls, including operating forces and placement. This is the clause that links the product to real-world usability by people with disability and by assistants.
Clauses 23 to 25 add product-family-specific requirements for mobile, fixed and portable assistive products. They cover brakes and locking devices, rough handling, movement over thresholds, push-handle position, turning diameter, stability on bathtub rims, bracket strength, slip resistance, and specific tests for raised toilet seats, bath boards, stools, back supports and seats.
Manufacturer information, packaging and reporting
Clause 26 requires instructions for use, pre-sale information, user information, service information and labelling. Clause 27 requires packaging to be assessed for protection during storage and transport. Clause 28 defines the minimum content of the test report, including sample identification, test conditions, results, deviations and pass-fail statements.
What terms does FprEN ISO 17966 define?
- Applied part - the part of the device that necessarily touches the user in normal use in order to perform its function.
- assistant - the person who helps a person with disability use the assistive product.
- assistive product - a product that improves functioning and reduces disability, including devices, instruments, equipment and software.
- fixed assistive product - a product designed to be fastened or secured in one place, either by shape or by fasteners.
- movable mobile assistive product - equipment that is intended to be moved from one place to another while supported by its own wheels or equivalent means.
- movable portable assistive product - equipment that is used with the user in place only when stationary and can be moved without the user in place.
- foreseeable misuse - wrongful use that can reasonably be anticipated.
- intended use - the use intended by the manufacturer in accordance with the product specifications, instructions and information.
- maximum user mass - the greatest user weight the manufacturer says the product is intended to support.
- maximum load - the greatest permissible weight on the product or a product part during normal use.
Who uses FprEN ISO 17966?
FprEN ISO 17966 is used by manufacturers of bathroom and toileting assistive products, design engineers, test laboratories, risk managers and quality teams. It is also relevant to clinical evaluators, regulatory teams and buyers who need to compare products against the same safety and performance basis.
The standard is especially relevant in home care, healthcare and sanitary-installation settings where products are used by disabled people and by assistants. It helps teams decide what to design, what to test, what to document and what to state in instructions for use and labelling.
Which standards are used with FprEN ISO 17966?
| Standard | What it contributes |
|---|---|
| EN 614-1:2006+A1:2009 | Ergonomic design principles and terminology |
| EN 1021-2:2014 | Ignitability assessment for upholstered parts |
| EN 12527:1998 | Castor and wheel test methods and apparatus |
| EN 60601-1:2006 and amendments | Base electrical safety requirements |
| EN 60601-1-11:2015+A1:2021 | Electrical safety in home healthcare use |
| EN IEC 60601-1-2:2021 | EMC requirements for electrical and electronic equipment |
| EN IEC 60601-2-35:2021 | Requirements for heated blankets, pads and similar flexible appliances |
| EN ISO 845:2009 | Density of cellular plastics and rubbers |
| EN ISO 2439:2009 | Hardness of flexible cellular materials |
| EN ISO 3746:2010 | Sound power measurement |
| EN ISO 9227:2022 | Salt spray corrosion testing |
| EN ISO 9999:2022 | Classification and terminology for assistive products |
| EN ISO 10993-1:2020 | Biocompatibility evaluation |
| EN ISO 12100:2010 | Risk assessment and risk reduction |
| EN ISO 13849 (all parts) | Safety-related control system design |
| EN ISO 14155:2020 | Clinical investigation of medical devices |
| EN ISO 14971:2019+A11:2021 | Medical device risk management |
| EN ISO 15223-1:2021 | Symbols for medical device labelling |
| EN ISO 20417:2021 | Information supplied by the manufacturer |
| EN ISO 22442-1:2020 | Risk management for animal tissues and derivatives |
| IEC 60068-2-31:2008 | Rough handling shock and free-fall testing |
| IEC 60332-1-2:2015 | Flame propagation of cables |
| IEC 60529:2019 | IP code for enclosure protection |
| IEC 60695-11-10:2013 | Flame test methods |
| IEC 61508 (all parts) | Functional safety principles for software and logic |
| ISO 7176-8:2014 | Static, impact and fatigue strength methods for load pads and related tests |
| ISO 7176-11:2012 | Test dummies |
| ISO 8191-2:1988 | Upholstered furniture ignitability |
| ISO 8373:2021 | Robotics vocabulary used in definitions |
| ANSI/UL 1581:2023 | Reference standard for electrical wires and cables |
What does the FprEN ISO 17966 document contain?
FprEN ISO 17966 contains general test apparatus requirements, including force, distance, angle, torque, sound and pressure measurement equipment, plus loading pads, impact pendulums, supporting stands and small-parts checks. It also contains test conditions for delivery state, indoor environment and use of a single product under test.
The document includes tables, figures and formulas for practical verification work. These cover safe gaps and clearances, skin-contact temperatures, operating forces, drop heights, durability-cycle calculations, and test setups for static strength, impact, stability, thresholds, foot traps and bathtub-rim products.
It also contains product-specific methods for mobile, fixed and portable product families, plus manufacturer-information requirements, packaging checks and minimum test-report content. Annexes then add guidance for cognitive impairment, chemical and environmental concerns, periodic inspection, lithium batteries and the EU MDR relationship.
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Consolidated By
ISO 17966 - Assistive products for toileting, bathing and showering — Requirements and test methods - Effective Date
- 12-Feb-2026
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Frequently Asked Questions
FprEN ISO 17966 is a draft published by the European Committee for Standardization (CEN). Its full title is "Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/FDIS 17966:2026)". 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
FprEN ISO 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.
FprEN ISO 17966 has the following relationships with other standards: It is inter standard links to EN ISO 8504-4:2024, EN ISO 8502-5:2025, ISO 17966. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
FprEN ISO 17966 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575, M/575 Amd 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
FprEN ISO 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)
SLOVENSKI STANDARD
oSIST prEN ISO 17966:2025
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
oSIST prEN ISO 17966:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 17966:2025
oSIST prEN ISO 17966:2025
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)
oSIST prEN ISO 17966:2025
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.
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NOTIFICATION OF ANY RELEVANT PATENT
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 17966:2024(en)
ii
oSIST prEN ISO 17966:2025
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
oSIST prEN ISO 17966:2025
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
oSIST prEN ISO 17966:2025
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
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oSIST prEN ISO 17966:2025
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
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oSIST prEN ISO 17966:2025
ISO/DIS 17966:2024(en)
Foreword
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rights in respect thereof. As of the date of publication of this doc
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