kSIST prEN ISO 17966:2026
(Main)Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/FDIS 17966:2026)
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
- Public Enquiry End Date
- 26-Jan-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 5020 - Formal vote (FV) (Adopted Project)
- Start Date
- 14-Aug-2026
- Due Date
- 02-Oct-2026
Overview
kSIST prEN ISO 17966:2026 - "Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/FDIS 17966:2026)" specifies essential requirements and test methods for a wide range of assistive products used in personal hygiene and sanitary care. These products, often intended to alleviate or compensate for disabilities, are considered medical devices in some jurisdictions. This standard, prepared by SIST in alignment with international regulations, ensures the safety, reliability, and performance of such products during both standard operation and foreseeable misuse.
Addressing both the user and potential assistant's safety and ergonomics, the document outlines procedures for testing structural integrity, material biocompatibility, mechanical operation, and electrical safety. It provides a foundation for manufacturers, regulators, and care providers to deliver assistive technology that meets high safety and usability benchmarks.
Key Topics
- Scope of Products:
- Commode chairs, raised toilet seats, toilet arm and back supports, bath boards, shower chairs, bathing stretchers, bidets, bathtubs, and various supports and rails.
- Includes both fixed and portable solutions designed for toileting, bathing, and showering.
- Safety Requirements:
- Performance under normal and foreseeable misuse.
- Prevention of hazards, entrapment, and excessive force requirements.
- Ergonomic and stability principles for both users and assistants.
- Test Methods:
- Materials testing for flammability, toxicity, corrosion resistance, and biocompatibility.
- Mechanical testing for static strength, impact, durability, and stability.
- Sound and vibration level checks for powered or electronic devices.
- Verification of controls, folding mechanisms, and adjustment features.
- Operational Features:
- Controls’ force and accessibility.
- Suitable dimensions and support surfaces.
- Requirements for mobile and removable products (e.g., shower chairs with wheels, grab rails).
- Exclusions:
- Safe mounting in building structures and permanent installations.
- Custom-made solutions for individual users.
- Certain categories such as bathtub hoists and mainstream diaper-changing tables (covered by other standards).
Applications
- Product Development:
- Assists medical device manufacturers in designing personal hygiene aids that conform to international safety and performance standards.
- Quality Assurance:
- Establishes a testing framework and acceptance criteria for product evaluation and certification.
- Healthcare Settings:
- Guides healthcare providers and institutions in the selection of compliant equipment for assisted living and home care environments.
- Regulatory Compliance:
- Serves as a reference for regulatory bodies to assess conformity of sanitary assistive products within healthcare and public facilities.
- User Safety & Comfort:
- Ensures end users and caregivers have access to products that are safe, robust, and ergonomically designed for ease of use and reduced injury risk.
Related Standards
- ISO 9999: Classification of assistive products for persons with disability - referenced to define divisions and codes for covered products.
- ISO 10535: Covers specific requirements for hoists and similar equipment, not encompassed within this standard.
- EN 12221-1 and EN 12221-2: Requirements for mainstream diaper-changing tables (for babies/toddlers).
- EN 14688: General requirements for wash basins - not fully covered in ISO 17966.
- Medical Device Regulations: National regulations may classify assistive products differently based on local definitions of medical devices.
By applying kSIST prEN ISO 17966:2026, stakeholders can help ensure high standards of safety, usability, and reliability in essential bathroom and hygiene assistive products, supporting independence and dignity for people with disabilities or limited mobility.
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
kSIST prEN ISO 17966:2026 is a draft published by the Slovenian Institute for Standardization (SIST). 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
kSIST prEN ISO 17966:2026 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; 91.140.70 - Sanitary installations. The ICS classification helps identify the subject area and facilitates finding related standards.
kSIST prEN ISO 17966:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 8502-5:2025, SIST EN ISO 8504-4:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
kSIST prEN ISO 17966:2026 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.
kSIST prEN ISO 17966:2026 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.