EN 60601-2-25

Area	Medical technology
title	Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
Latest edition	4.2001
ISO	IEC 60601-2-25: 1993 + A1: 1999

The EN 60601-2-25 titled "Electrical Medical devices - Part 2-25: Particular requirements for the safety of electrocardiographs" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-25 .

The standard is based on the international version IEC 60601-2-25. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-25 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines for electrocardiographs .

validity

The German edition of April 2001 has been adopted as a German standard from May 2002 .

Attention: In February 2008 a new draft was published.
The current version (4.2001) is to be used in accordance with the 2nd edition of DIN EN 60601-1.
Draft 2.2008 is to be used in accordance with the 3rd edition of DIN EN 60601-1.

scope of application

These special stipulations specify special requirements for the safety of electrocardiographs for the creation of removable electrocardiograms for diagnostic purposes. It is also applicable to vector cardiographs and exercise equipment. These special stipulations contain minimum security requirements.

Special requirements relating to use in ambulances, namely phonocardiographs, cardiography monitors, polygraphs , telemetry , special examinations (e.g. bundle-his-beam electrocardiographs), etc., are not covered by this particular provision. Devices with microelectrodes that are used directly in the fibers of the heart muscle are excluded .

extra information

The following changed requirements are contained in EN 60601-2-25 (extract):

Defibrillation resistance
Interference immunity (EMC)
Dielectric strength