IS 19173 : Part 1 : 2025/IEC/TR 80002-1 : 2009 Medical Device Software - Part 1 Guidance on the Application of ISO 14971 to Medical Device Software

ICS 11.040.01

MHD 14

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical adoption of IEC/TR 80002-1 : 2009 'Medical device software: Part 1 Guidance on the application of ISO 14971 to medical device software' issued by the International Electrotechnical Commission 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.