Aktívna norma | Vydaná: 11.08.2014

ISO 14708-1:2014-ed.2.0

Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
(Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations a fournir par le fabricant)

Dostupné jazyky: Anglicky

Dostupné prevedenie: Elektronické PDF, Tlačené

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Podrobné informácie

Označenie: ISO 14708-1:2014-ed.2.0

Dátum vydania: 11.08.2014

Stránok: 57

Krajina: Medzinárodná technická norma

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Anotácia

Description / Abstract: ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance. ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.

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