The ISO 22442 series for medical devices that use animal tissues has been updated. There are new 2nd Editions for both ISO 22442-1 and ISO 22442-2. The new revisions are available from Document Center Inc., an authorized distributor of ISO standards. The series addresses issues linked to animal tissues (and their derivatives.) These materials can provide performance benefits in such devices as heart valves, bone substitutes, collagen implants, and so on.
We’ll discuss each of the new editions separately below:
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
ISO 22442-1 covers medical devices other than in vitro diagnostic devices. The animal tissues addressed by the standard are non-viable (or have been rendered so.) You’ll need to use ISO 22442-1 with ISO 14971, since it is not a “standalone” standard.
Changes in this new edition are minor. From a cursory review, revisions have been made to such things as dates in the referenced documents section, an added reference to Part 4 in the foreward, and so on. However, the 2nd Edition does cancel and replace the 1st Edition from 2007, so if you use this document you’ll need a copy of the new update.
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
The new 2nd Edition for Part 2 is also a minor revision. The standard covers the issues of controlling quality and purity throughout the procurement process. This is especially important since contamination prior to inclusion in a medical device can lead to negative outcomes for patients.
Again the new 2nd Edition cancels and replaces the previous 1st Edition from 2007. You will need to get a copy if you use the standard in your business.
Note: ISO 22442-3 (Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents) and ISO/TR 22442-4 (Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes) are not under revision and remain valid at this time.
Now to get a copy. You can rely on Document Center Inc. to provide you with not only the standards you need, but also the supporting services to keep your collection current. Order any standard on our webstore, www.document-center.com. Here’s the direct link for the order page for ISO 22442-1 and the order page for ISO 22442-2.
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