Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 27) which is identical with IEC 60601-2-27 : 2011 ‘Medical electrical equipment — Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment’ issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on the recommendation of the Electromedical, Diagnostic Imaging and Radiotherapy Equipment Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

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 Standard.

Technical Corrigenda 1 published in 2012 is given at the end of this publication.

This particular standard concerns the Basic safety and essential performance of electrocardiographic monitoring 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.

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. It is considered that knowledge of the reasons for these requirements will not only facilitate the 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 an Indian Standard without deviations. Certain conventions are however not identical to those used in 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.