
Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
出版:Standards Australia

專家解讀視頻
Proposes general requirements for evaluating the interactions of medical devices with blood. It describes 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, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.