BS EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

Standard No.

BS EN ISO 22442-3:2007

Release Date

2008

Published By

British Standards Institution (BSI)

Status

Be replaced 2008-02

Replace By

BS EN ISO 22442-3:2008

Latest

BS EN ISO 22442-3:2008

Scope

BS EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents For the safety of medical devices there are two complementary approaches (see BS EN ISO 22442-1 ) that can be adopted to control the potential contamination of tissues. These typically are: • Selecting source material for minimal contamination with viruses and/or TSE agents (see BS EN ISO 22442-1 and BS EN ISO 22442-2 ) • Providing valid scientific evidence to demonstrate the ability of the production processes to eliminate or inactivate viruses and/or TSE agents ( BS EN ISO 22442-3 ). Requirements for a quality system for medical devices for regulatory use are specified in BS EN ISO 13485:2003 Medical devices. Quality management systems. Requirements for regulatory purposes . The standards for quality management systems recognize that, for certain processes used in manufacturing, the effectiveness of that process cannot be fully verified by subsequent inspection and testing of the product. The elimination and/or inactivation of viruses and TSE agents is an example of a special process because process efficacy cannot be verified by inspection and testing of the product. For this reason, the following need to be considered in particular: Definition of the process(es) and materials to be used Adequate inactivation validation before routine use Performance monitoring of the process during manufacture Appropriate equipment maintenance Staff training. Historically there have been many instances of unknown or unsuspected viral contamination during manufacture. For this reason, evaluation of the manufacturing process can provide a ...

BS EN ISO 22442-3:2007 history

• 2008 BS EN ISO 22442-3:2008 Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
• 2008 BS EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents