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Norm
ÖNORM EN 1041
Issue date: 2013 11 15
Information supplied by the manufacturer of medical devices
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to a...
Withdrawn: 2021 11 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 31 Pages
Language:
German
| English
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 European 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.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
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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Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
