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STANDARD

Current

ÖNORM EN ISO 21856

Issue date: 2022 12 15

Assistive products - General requirements and test methods (ISO 21856:2022)

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.

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General information on ÖNORM EN ISO 21856

Format

Digital | 70 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 196 Assistive products for persons with disability

Timeline

An overview of the development of ÖNORM EN ISO 21856 from 1999 til today.

• ÖNORM EN ISO 21856

  2022 12 15 Standard ÖNORM EN ISO 21856, Edition: 2022 12 15

  Assistive products - General requirements and test methods (ISO 21856:2022)
• ÖNORM EN 12182

  2012 06 15 Standard ÖNORM EN 12182, Edition: 2012 06 15

  Assistive products for persons with disability - General requirements and test methods
• ÖNORM EN ISO 16201

  2007 01 01 Standard ÖNORM EN ISO 16201, Edition: 2007 01 01

  Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006...
• ÖNORM EN ISO 16201

  2006 12 01 Standard ÖNORM EN ISO 16201, Edition: 2006 12 01

  Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006...
• ÖNORM EN 12182

  1999 12 01 Standard ÖNORM EN 12182, Edition: 1999 12 01

  Technical aids for disabled persons - General requirements and test methods

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer IEC 60695-11-10	Titel Fire hazard testing Test flames -- 50 W horizontal and vertical flame test methods	Ausgabedatum 1999 03 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-1:2018	Titel Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)	Ausgabedatum 2018 08 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 11135:2014	Titel Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2014 07 07	Art Standard	Zur Produktseite
Dokumentnummer ISO 11137-1:2006	Titel Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2006 04 19	Art Standard	Zur Produktseite
Dokumentnummer ISO 11137-2:2013	Titel Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose	Ausgabedatum 2013 05 21	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607-1:2019	Titel Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems	Ausgabedatum 2019 01 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 12100:2010	Titel Safety of machinery — General principles for design — Risk assessment and risk reduction	Ausgabedatum 2010 10 20	Art Standard	Zur Produktseite
Dokumentnummer ISO 12952-1:2010	Titel Textiles — Assessment of the ignitability of bedding items — Part 1: Ignition source: smouldering cigarette	Ausgabedatum 2010 09 23	Art Standard	Zur Produktseite
Dokumentnummer ISO 14155:2020	Titel Clinical investigation of medical devices for human subjects — Good clinical practice	Ausgabedatum 2020 07 28	Art Standard	Zur Produktseite
Dokumentnummer ISO 14971:2019	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2019 12 10	Art Standard	Zur Produktseite
Dokumentnummer ISO 15223-1:2021	Titel Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)	Ausgabedatum 2021 07 06	Art Standard	Zur Produktseite
Dokumentnummer ISO 20417:2021	Titel Medical devices — Information to be supplied by the manufacturer (Corrected version 2021-12)	Ausgabedatum 2021 04 13	Art Standard	Zur Produktseite
Dokumentnummer ISO 22442-1:2020	Titel Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management	Ausgabedatum 2020 09 15	Art Standard	Zur Produktseite
Dokumentnummer ISO 24415-1:2009	Titel Tips for assistive products for walking — Requirements and test methods — Part 1: Friction of tips	Ausgabedatum 2009 04 01	Art Standard	Zur Produktseite
Dokumentnummer ISO 24415-2:2011	Titel Tips for assistive products for walking — Requirements and test methods — Part 2: Durability of tips for crutches	Ausgabedatum 2011 08 03	Art Standard	Zur Produktseite
Dokumentnummer ISO 25424:2018	Titel Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2018 10 19	Art Standard	Zur Produktseite
Dokumentnummer ISO 3746:2010	Titel 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	Ausgabedatum 2010 11 25	Art Standard	Zur Produktseite
Dokumentnummer ISO 7000:2019	Titel Graphical symbols for use on equipment — Registered symbols	Ausgabedatum 2019 07 12	Art Standard	Zur Produktseite

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