This National Standard of Canada is equivalent to International Standard ISO 10993-4:1992. 1 Scope This part of ISO 10993 gives guidance to agencies, manufacturers, research
laboratories and others 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; c) the rationale for structured selection of tests, together with the
principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of the
limitations in knowledge and precision of tests for interactions of devices
with blood.