Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO/TR 24971 : 2020 ‘Medical devices - Guidance on the application of ISO 14971’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2013 based on ISO/TR 24971 : 2007. This revision has been undertaken to align with ISO/TR 24971 : 2020 ‘Medical devices - Guidance on the application of ISO 14971’.