New Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard is identical with ISO 22442-3 : 2007 ‘Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and or inactivation of viruses and transmissible spongiform encephalopathy TSE agents’ issued by the International Organization for Standardization was adopted by Bureau of Indian Standards on recommendation of Biological Evaluation of In-vitro Diagnostic Medical Devices Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

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

Part 1 Application of risk management

Part 2 Controls on sourcing, collection and handling

Part 4 Principles for elimination and or inactivation of transmissible spongiform encephalopathy TSE agents and validation assays for those processes

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies 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.