ISO 21856:2022
Assistive products — General requirements and test methods

Standard No.

ISO 21856:2022

Release Date

2022

Published By

International Organization for Standardization (ISO)

Latest

ISO 21856:2022

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.

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*， 2024-04-22 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*， 2024-04-22 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***)*， 2024-04-22 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*， 2024-04-22 Update
• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2024-04-22 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 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

ISO 21856:2022 history

• 2022 ISO 21856:2022 Assistive products — General requirements and test methods