Ehdotuksen tiedot

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. 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. This document does not apply for: