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
Class/Status: Standard, valid
Released: 2016-02
VDE Art. No.: 0700931

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This European Standard specifies general requirements for active implantable medical devices, to provide basic assurance of safety for both patients and users. 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.

Replacement for:
DIN EN 45502-1 VDE 0750-10:1998-07

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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