DIN Standards Committee Technical Fundamentals
DIN EN 45502-1
; VDE 0750-10:2016-02
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer; German version EN 45502-1:2015
Aktive implantierbare medizinische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit, Aufschriften und vom Hersteller zur Verfügung zu stellende Informationen; Deutsche Fassung EN 45502-1:2015
Overview
This standard is the result of the revision related to the amended Active Implantable Medical Devices Directive (AIMDD) and specifies requirements for active implantable medical devices as a basis for patient and operator safety. This standard 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) as well as is to some non-implantable parts and accessories. The standard is technically identical to the already published ISO 14708-1, making it easier for manufacturers to consider active implantable medical devices for regulatory purposes in Europe and in America in the future. The responsible committee is DKE/GUK 812.5 "Aktiv betriebene Implantate" ("Active implantable medical devices") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/GUK 812.5 - Aktiv betriebene Implantate
