[Superseding IS 8048 : 1985]

Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 25) which is identical with IEC 60601-2-25 : 2011 ‘Medical electrical equipment — Part 2-25 : Particular requirements for the basic safety and essential performance of electrocardiographs’ issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on the recommendation of the Electromedical and Diagnostic Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This Indian Standard was first published in 1976 as IS 8048 and was subsequently revised in 1985 to incorporate development taken place at the time. Now this revision has been taken up to align it with IEC 60601-2-25 : 2011 and is being published in the Indian Standards series of IS 13450 on Electro Medical Equipment to have uniformity. On publication his standard will supersede IS 8048 : 1985 ‘Specification for electrocardiograph (first revision).

Only the English language text has been retained while adopting it in this standard and as such the page numbers given here are not the same as in the IEC Publication.

This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC EQUIPMENT. It amends and supplements IS 13450 (Part 1) : 2008/IEC 60601-1(2005) ‘Medical electrical equipment : Part 1 General requirements for basic safety and essential performance’, hereinafter referred to as the general standard.

This particular standard now includes the contents of the particular standard IEC 60601-2-51 : 2003 ‘Medical electrical equipment — Part 2-51: Particular requirements for the safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs’.

The requirements of this particular standard take priority over those of the general standard.

A “General guidance and rationale” for the more important requirements of this particular standard is included in Annex AA. Knowledge of the reasons for these requirements will not only facilitate proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, Annex AA does not form part of the requirements of this standard

The text of IEC Standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.