Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard is identical with ISO/TR 15499 : 2016 ‘Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on recommendation of the Biological and Clinical Evaluation of Medical Devices and Immuno-Biological Diagnostic Kits Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

The text of ISO 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.