Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

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.

read more

General information on ÖNORM EN ISO 21856

Format

Paper | 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

Read more

Frequently Asked Questions about ÖNORM EN ISO 21856

What is a "Single-User Licence"?

When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.

Find out more about the benefits of multi-user licences

How can I get involved in the further development of this standard?

Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.

Find out more about getting involved in standardization

How can I manage my standards efficiently?

If you have an extensive portfolio of standards, we recommend using a professional standards management tool. With effects 2.0, you can manage your standards centrally and efficiently. You can optimise your procurement processes and benefit from an integrated information and subscription service. This ensures you are always up to date and never miss any relevant developments.

Find out more about the benefits of effects 2.0

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

load more

Recently Viewed

ÖNORM EN ISO 24223

Milk and milk products - Guidance on sample preparation for physical and chemical testing (ISO/DIS 24223:2025)

ÖVE/ÖNORM EN 61056-2

General purpose lead-acid batteries (valve-regulated types) - Part 2: Dimensions, terminals and marking (IEC 61056-2:2012 + Corrigendum Oct. 2012)

ÖNORM EN 18021

Sanitary tapware - Measurement of functional performance of taps and showers