Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with IEC 82304-1 : 2016 ‘Health software — Part 1: General requirements for product safety’ issued by the International Electrotechnical Commission (IEC) was adopted by the Bureau of Indian Standards on recommendation of the Health Informatics Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The text of the IEC Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain terminologies and 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.