What is ISO 22442‑1 about?
ISO 22442 discusses medical devices utilizing animal tissues and their derivatives. ISO 22442‑1 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable.
ISO 22442‑1 outlines the decision process for the residual risk acceptability, considering the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives.
Note 1: ISO 22442‑1 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives, and amino acids.
Note 2: ISO 22442‑1 does not specify a quality management system for the control of all stages of production of medical devices.
Note 3: ISO 22442‑1 does not cover the utilization of human tissues in medical devices.
Who is ISO 22442‑1 for?
ISO 22442‑1 on medical devices utilizing animal tissues and their derivatives is useful for:
- Manufacturers of medical devices utilizing animal tissues
- Test centers for medical devices
- Medical laboratories
- Regulatory authorities
Why should you use ISO 22442‑1?
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 22442‑1 helps you with procedures to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
ISO 22442‑1 provides requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as contamination by bacteria, molds or yeasts, contamination by viruses, contamination by agents causing transmissible spongiform encephalopathies (TSE), and material responsible for undesired pyrogenic, immunological, or toxicological reactions. This helps you control risks and monitor the effective control throughout the life cycle of medical devices utilizing animal tissues and their derivatives.
What’s changed since the last update?
BS EN ISO 22442‑1:2020 supersedes ISO 22442‑1:2015, which has been withdrawn. BS EN ISO 22442‑1:2020 has some technical changes with respect to ISO 22442‑1:2015. These include:
- 4.4.2 has been updated
- Weblinks in C.2, bullet point 1, C.3.3, and C.4.4 have been updated
- The web link in D.3.3 has been updated
- C.10 has been added
- The bibliography has been updated