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Biological evaluation as part of risk assessment
Lise S Bollen1, Robert J Harling
1Scantox A/S, Hestehavevej, Ejby, DK-4623 Lille Skensved, Denmark.
Medical Device Technology
|July 16, 2002
Abstract:
This overview of how to conduct a risk assessment highlights the use of one of the newest standards in this area ISO 14971, which covers the application of risk management, as well as ISO 10993, which covers biological evaluation of medical devices. A hypothetical risk evaluation of a device is also described.