ISO/TR 15499:2012, “Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process,” has just been released and is now available from Document Center Inc. The new Technical Report provides guidance on conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1.
This document can be used to better understand the requirements of ISO 10993-1 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 10993-1. Biological evaluation is a design verification activity which is set in the context of broader risk management processes. This means ISO/TR 15499 includes guidance on the application of ISO 10993-1 in the context of risk management processes conducted according to the requirements of ISO 14971.
Guidance contained in this Technical Report can also be useful as background information for those representing risk management process assessors, conformity assessment bodies and regulatory enforcement bodies.
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