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Norm
ÖNORM EN 1041
Issue date: 2008 11 01
Information supplied by the manufacturer with medical devices
This standard specifies requirements for information to be supplied by a manufacturer for medical devices
regulated by Council Directive 90/385/EEC relating to active im...
Withdrawn: 2013 11 15
Publisher:
Austrian Standards International
Format:
Digital | 29 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
Topics
show all
Healthcare, Pharmaceutics, Pharmaceutics in general
Healthcare, Medical equipment, Medical equipment in general
Mechanical engineering foundations & materials, Technical drawing and graphical symbols, Technical product documentation
Services & management, Technical drawing and graphical symbols, Technical product documentation
Services & management, Information sciences. Publishing. Terminology, Technical product documentation
This standard specifies requirements for information to be supplied by a manufacturer for medical devices
regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive
93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor
does it specify the means by which the information is to be supplied. It is also intended to complement the
specific requirements of the cited EU Directives on medical devices by providing guidance on means by which
certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of
conformity with the relevant Essential Requirements regarding information to be supplied.
ÖVE/ÖNORM EN ISO 20417
2022 09 01
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version ...
Norm
ÖVE/ÖNORM EN ISO 20417
2021 11 15
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
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SI units and recommendations for the use of their multiples and of certain other units
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Nomenclature - Collective terms and codes for groups of medical devices
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Issue date :
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Information supplied by the manufacturer of medical devices
