IS/IEC/TR 80002 : Part 3 : 2014 Medical Device Software - Part 3 Process Reference Model of Medical Device Software Life Cycle Processes

NATIONAL FOREWORD

This Indian Standard (Part 3) which is identical to IEC/TR 80002-3 : 2014 'Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The text of the ISO 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' appears referring to this standard, they should be read as 'Indian Standard'; and

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