
Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood
出版:Danish Standards

专家解读视频
Gives general requirements for evaluating the interactions of medical devices with blood. It also explains: 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 according to specific categories, together with the principles and scientific basis of these tests.
EN ISO 10993-4:2009 - Identical