ISO 14708-1:2014Published

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 à fournir par le fabricant

A new edition is under development: ISO/DIS 14708-1.

Abstract / scope

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.

Life cycle

Replaces

ISO 14708-1:2000WithdrawnImplants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturerInternational Standard · Published 23 Nov 2000 · ISO/TC 150/SC 6

Replaced by

ISO/DIS 14708-1Under developmentImplants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturerInternational Standard · ISO/TC 150/SC 6 ISO/PWI 14708-1Deleted (project abandoned)Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturerInternational Standard · ISO/TC 150/SC 6