prEN ISO 17966

Scope

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