DIN EN 60601-2-47 VDE 0750-2-47:2016-02

* German Language Version *

Medical electrical equipment

Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

(IEC 60601-2-47:2012); German version EN 60601-2-47:2015
Class/Status: Standard, valid
Released: 2016-02
VDE Art. No.: 0700924

Contents

This standard specifies the basic safety and essential performances for ambulatory electrocardiographic systems (medical electrical equipment). Within the scope of this standard are systems of the following types:
a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard;
b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG.
This standard amends DIN EN 60601-1 (VDE 0750-1):2007-07.

Replacement for:
DIN EN 60601-2-47 VDE 0750-2-47:2002-11

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