NATIONAL FOREWORD

This Indian Standard (Part 4) which is identical with ISO/TR 22442-4 : 2010 ‘Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Immuno-Biological Diagnostic Kits Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

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

Part 1 Application of risk management

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 Technical Report 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’ 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.