What is ISO 22442-2 about?
Certain medical devices use materials of animal origin. ISO 22442 discusses medical devices utilizing animal tissues and their derivatives. ISO 22442-2 outlines requirements for controls on the sourcing, collection, and handling (includes storage and transport) of animals and tissues for the manufacture of medical devices. ISO 22442-2 is for manufacturers that utilise materials of animal origin other than in vitro diagnostic medical devices.
ISO 22442-2 applies where required by the risk management process as described in ISO 22442-1.
Note 1: Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e., when utilising animal tissue and/or their derivative originating from bovine, ovine, and caprine species, deer, elk, mink, or cats.
Note 2: ISO 22442-2 does not cover the utilization of human tissues in medical devices.
Note 3: ISO 22442-2 does not specify a quality management system for the control of all stages of production of medical devices.
Who is ISO 22442-2 for?
ISO 22442-2 on medical devices utilizing animal tissues and their derivatives is useful for:
- Manufacturers of medical devices utilizing animal tissues
- Medical laboratories
- Regulatory authorities
Why should you use ISO 22442-2?
Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide performance characteristics that have been chosen for advantages over non-animal-based materials.
ISO 22442-2 guidelines help you with general requirements, species, strains, geography, inspection, certification, traceability, collection, handling, storage, transportation, and labelling for medical devices utilizing animal tissues and their derivatives. This reduces time and improves the flow of operation.
What’s changed since the last update?
BS EN ISO 22442-2:2020 supersedes ISO 22442-2:2015, which has been withdrawn. BS EN ISO 22442-2:2020 has some technical changes with respect to ISO 22442-2:2015. These include:
- Update of the web link on stunning technique in A.3.2.5 Note 1
- Clarification on scope inclusion of cervid-sourced materials, and other TSE susceptible species
- Clarification on atypical BSE types, especially in combination with intracranial applications
- Enhanced expectation of using validated biochemical testing to establish TSE presence
