Standards Development

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 standard) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability.

NOTE 1 Assistive products are considered to be medical devices in some jurisdictions but not in others.

The standard 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 EN ISO 9999:2022.

There are no specific requirements and test methods for products marked with

*. Only the relevant general requirements apply when these products are considered to be medical devices.

09 12 03 Commode chairs;   Chairs, with or without castors, with a collection receptacle used for toileting away from the bathroom

09 12 06 Toilets;*

Included are, e.g. raised or height adjustable toilets, toilets with built-in douche and air dryers.

09 12 09 Toilet seats;*  

Devices attached to the toilet bowl or toilet chair for a person to sit on; they can provide stability and comfort

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;

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 prEN 12221:2023.

09 33 15 Wash basins;*  

Stationary or portable basins for water used when washing parts of the body

09 33 18 Bidets;*  

Stationary or portable basins primarily intended for washing genitals and bottom

09 33 36 Assistive products for drying oneself;*  

Devices and materials for enabling a person to dry his/her 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 himself/herself 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 her/his 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

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 EN 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.