BS EN ISO 21856:2022
Assistive products. General requirements and test methods

Standard No.

BS EN ISO 21856:2022

Release Date

2022

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 21856:2022

Scope

1   Scope This document specifies general requirements and test methods for assistive products , considered to be medical devices , intended for use to alleviate or compensate for a disability . This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user . NOTE 1 Assistive products are considered to be medical devices in some jurisdictions but not in others. NOTE 2 Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33]. NOTE 3 Not all the items listed in ISO 9999 are medical devices . Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices .

BS EN ISO 21856:2022 Referenced Document

• EN 1021-2 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent
• EN 556-1 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-21 Update
• EN 597-1 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source: smouldering cigarette
• EN 597-2 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: match flame equivalent
• EN 614-1 Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
• EN 716-2:2017 Furniture - Children's Cots and Folding Cots for Domestic Use - Part 2: Test Methods
• IEC 60204-1 Safety of machinery - Electrical equipment of machines - Part 1: General requirements*， 2024-04-21 Update
• IEC 60332-1-2 Tests on electric and optical fibre cables under fire conditions - Part 1-2: Test for vertical flame propagation for a single insulated wire or cable - Procedure for 1 kW pre-mixed flame
• IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) (Edition 2.1 ***Applies to French text only***)*， 2024-04-21 Update
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-21 Update
• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2024-04-21 Update
• IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 12100 Safety of machinery - General principles for design - Risk assessment and risk reduction
• ISO 12952-1 Textiles - Assessment of the ignitability of bedding items - Part 1: Ignition source: smouldering cigarette
• ISO 12952-2 Textiles - Assessment of the ignitability of bedding items - Part 2: Ignition source: match-flame equivalent
• ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
• ISO 20417 Medical devices — Information to be supplied by the manufacturer
• ISO 21856:2022 Assistive products — General requirements and test methods
• ISO 22442-1 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
• ISO 24415-1 Tips for assistive products for walking - Requirements and test methods - Part 1: Friction of tips
• ISO 24415-2 Tips for assistive products for walking - Requirements and test methods - Part 2: Durability of tips for crutches
• ISO 25424 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
• ISO 3746 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis

BS EN ISO 21856:2022 history

• 2022 BS EN ISO 21856:2022 Assistive products. General requirements and test methods