IS 13450 : Part 2 : Sec 4 : 2018/IEC 60601-2-4 : 2010 Medical Electrical Equipment Part 2 Particular Requirements for the Basic Safety and Essential Performance Section 4 Cardiac defibrillators

ICS 11.040.100

MHD 15

Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 2/Sec 4) (First Revision) which is identical with IEC 60601-2-4 : 2010 ‘Medical electrical equipment — 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators’ 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.

This standard was first published in 1988 and subsequently revised in 2009 by adopting IEC 60601-2-4 : 2005 and published as IS 13450 series. On revision of IEC Standard this revision has been taken up to align it with the latest IEC 60601-2-4.

This particular standard concerns the safety of cardiac defibrillators. The general requirements for safety are given in IS 13450 (Part 1) : 2008 ‘Medical electrical equipment : Part 1 General requirements for the basic safety and essential performance (first revision)’ also referred as ‘General Standard’ in this particular standard.

Only the English language text in the International Standard has been retained while adopting it in this Indian 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.