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Norm
ÖNORM EN 12182
Issue date: 2012 06 15
Assistive products for persons with disability - General requirements and test methods
This European Standard specifies general requirements and test methods for assistive products for persons
with a disability, which are medical devices according to the d...
Withdrawn: 2022 12 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 65 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This European Standard specifies general requirements and test methods for assistive products for persons
with a disability, which are medical devices according to the definition laid down in the EU Directive
93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by
administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply.
However, some of the requirements of this standard may still apply and may be considered in addition to
those in other European standards.
ÖNORM EN ISO 21856
2022 12 15
Assistive products - General requirements and test methods (ISO 21856:2022)
Norm
ÖNORM EN 12182
2012 06 15
Assistive products for persons with disability - General requirements and test methods
Norm
↖
ÖNORM EN 12182
1999 12 01
Technical aids for disabled persons - General requirements and test methods
Norm
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Issue date :
2006 04 01
Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette
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Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent
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Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source: Smouldering cigarette
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Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: Match flame equivalent
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Information supplied by the manufacturer with medical devices
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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
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2008 10 01
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2007 08 01
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
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Issue date :
2012 06 01
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
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Issue date :
2008 04 01
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
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Issue date :
2009 02 01
Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
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2009 09 15
Tips for assistive products for walking - Requirements and test methods - Part 1: Friction of tips (ISO 24415-1:2009)
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Issue date :
2011 03 01
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 3746:2010)
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Issue date :
2011 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
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Issue date :
2010 12 15
Textiles - Assessment of the ignitability of bedding items - Part 2: Ignition source: match-flame equivalent (ISO 12952-2:2010)
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Issue date :
2012 02 15
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor 1:2011)
Norm
Issue date :
2011 08 01
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
Norm
Issue date :
2022 12 15
Assistive products - General requirements and test methods (ISO 21856:2022)
