Revised Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with ISO 22442-1 : 2015 ‘Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management’ 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.

This standard is published in various parts. The other parts in this series are:

Part 2 Controls on sourcing, collection and handling

Part 3 Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

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.