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Norm
ÖNORM EN 1041
Issue date: 1998 07 01
Information supplied by the manufacturer with medical devices
This standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directive...
Withdrawn: 2008 11 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 28 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 standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide 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)
Norm
Norm
Issue date :
2006 07 01
Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601:2004)
Norm
Issue date :
2008 11 01
Information supplied by the manufacturer with medical devices
