ISO 22442-3 Medical Devices Using Animal Tissues and Derivatives - Verification of Elimination and Inactivation of Viruses and Agents of Infectious Spongy Encephalopathy

ISO 22442-3 specifies requirements for the validation of the elimination or inactivation of viruses and TSE agents during the manufacture of medical devices (other than in vitro diagnostic medical devices) using animal tissue or products derived from animal tissue. It is applied where required by the risk management process as described in ISO 22442-1. It does not cover other infectious and non-infectious substances.

Appropriate equipment specified in a protocol will be used. All equipment requiring scheduled maintenance should be maintained in accordance with documented procedures. Maintenance records should be maintained.

In particular, any equipment must be able to deliver the intended process within specified limits. In addition, if the equipment used during verification is not the same as that used in normal production cycles, sufficient documentation must be available to demonstrate that the performance parameters are equivalent to those used in the production cycle.

Additional parts of experimental systems, such as chemicals, cell systems, and laboratory animals used for validation studies should be adequately described, justified, controlled and documented.

EUROLAB assists manufacturers with ISO 22442-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.