Historical
ANSI/AAMI/ISO 10993-4:2002 (R2009)/A1:2006 (R2009)
Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood
Provides general requirements for evaluating the interactions of medical devices with blood. It describes: (a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1; (b) the fundamental principles governing the evaluation of the interaction of devices with blood; and (c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Association for the Advancement of Medical Instrumentation [aami]