ISO 22442-2 Medical Devices Using Animal Tissues and Derivatives - Controls Over Sourcing, Collection and Processing

This standard specifies requirements for controls over the procurement, collection and processing (including storage and transport) of animals and tissues for the manufacture of medical devices using materials of animal origin other than in vitro diagnostic medical devices. It is applied where required by the risk management process as described in ISO 22442-1.

This standard does not cover the use of human tissues in medical devices. It does not specify a quality management system for the control of all stages of the production of medical devices.

Cervids (Deer family) are now included in the list of animals whose supply of animal material cannot be overseen by a veterinarian. The rationale for this should be documented and a relevant sampling plan provided. Manufacturers should apply the relevant parts of the standard to such materials, but may need to rely on other procedures that have been shown to be effective for risk reduction.

It is important to note that the additions emphasize the fact that; If a producer uses bovine animal material or derivatives and wishes to facilitate testing, sourcing and processing requirements with full risk management, such material is encouraged to be obtained from young animals. cattle deemed fit for human consumption and preferably sourced from countries with acceptable levels of BSE risk as specified in the guideline.

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