CAN/CSA-ISO 10993.4-97 (R2006)
Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions With Blood (Adopted ISO 10993-4:1992)
This part of ISO 10993 gives guidance to agencies, manufacturers, research laboratories and others for evaluating the interactions of medical devices with blood.
(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.