ISO 22442

• ISO 22442-1:2020 – Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
• ISO 22442-2:2020 – Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling  
• 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

Summary

The ISO 22442 series of guidance provides a comprehensive summary of the risk assessment, control of source materials, and performance of a viral and TSE clearance study to validate the manufacturing process for the capability to inactivate and/or remove viral contaminants for animal tissue-derived medical devices.  The ISO 22442-3, in particular, provides detailed guidance on the design, performance and data interpretation of a viral/TSE clearance study.

Typical Test Substances

• Animal or human tissue-derived medical device

Outline of Test Procedure

• Risk assessment regarding viral safety
• Selection of target viruses and process steps to be evaluated for viral elimination
• Preliminary studies of viral recovery, cellular toxicity and viral interference
• Viral-spiking runs
• Data collection and reporting

Regulatory Agencies / Purpose

• U.S. Food and Drug Administration (FDA)
• European Agencies
• Other international agencies 

Similar Methods

• ICH Q5A
• Other viral clearance and adventitious testing methods