DIN EN ISO 17966:2024-12
Assistive products for toileting, bathing and showering - Requirements and test methods (ISO/DIS 17966:2024); German and English version prEN ISO 17966:2024 / Note: Date of issue 2024-11-08
| Fecha edición: |
2024-12-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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: 091203 Commode chairs; 091206 Toilets; 091209 Toilet seats; 091210 Toilet splash guards; 091212 Raised toilet seats mounted on frame; 091215 Toilet seats inserts; 091218 Raised toilet seats fixed to toilet; 091221 Toilet seats with built-in raising mechanism to help standing up and sitting down; 091224 Toilet arm supports and toilet back supports mounted on toilet; 091225 Toilet arm supports and toilet back supports, free standing; 091236 Douches and air dryers for attachment to a toilet; 093304 Bath boards 093305 Bath seats 093307 Shower chairs with and without wheels 093308 Back supports for bath or shower 093312 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. 093315 Wash basins NOTE: General requirements for wash basins are covered by EN 14688. 093318 Bidets 093321 Bathtubs 093336 Assistive products for drying oneself 181506 Height adjustable plinths and brackets; 181803 Handrails and support rails; 181806 Fixed grab bars and handgrips; 181810 Removable grab rails and handgrips; 181811 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; - 123615 bathtub hoists that are covered by ISO 10535; - 093321 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 |
| Keywords: | Aid|Aids|Armrests|Auxiliary staff|Back of seat|Bathing|Baths|Closets|Compensation|Definitions|Elevated|Ergonomics|Force measurement|Functionality|Functions|Handle shafts|Hindrance|Lifting appliances|Medical devices|Medical products|Performance requirements|Safety|Showers|Specification (approval)|Splash guard|Testing|Toilet seats|Wash-basins|WC compartments |
| ICS: | 11.180.99 - Otras normas relativas a las ayudas para personas con discapacidad, 11.180.01 - Ayudas para personas con discapacidad en general |
| CTN: |
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