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Norm
ÖVE/ÖNORM EN ISO 20417
Ausgabedatum: 2021 11 15
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. Thi...
ZURÜCKGEZOGEN: 2022 09 01
Herausgeber:
Austrian Standards International
Format:
Digital | 82 Seiten
Sprache:
Englisch
Aktuell Gültig:
Stellungnahmen:
Standards mitgestalten:
ICS
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
ÖVE/ÖNORM EN ISO 20417
2022 09 01
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen (ISO 20417:2021, k...
Norm
ÖVE/ÖNORM EN ISO 20417
2021 11 15
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Norm
↖
ÖNORM EN 1041
2013 11 15
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten
Norm
ÖNORM EN 1041
2008 11 01
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten
Norm
ÖNORM EN 1041
1998 07 01
Bereitstellung von Informationen durch den Hersteller eines Medizinprodukts
Norm
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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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2017 08 21
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
Norm
Ausgabedatum :
2022 09 01
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen (ISO 20417:2021, korrigierte Fassung 2021-12)