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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.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]