Historical
ANSI/AAMI/ISO 10993-17-2002
Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances
Specifies the methods to be used to determine allowable limits for leachable substances in medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
Association for the Advancement of Medical Instrumentation [aami]