ISO 10993-4:2002提供了评估医疗器械与血液相互作用的一般要求。 它描述 根据ISO 10993-1中定义的预期用途和接触持续时间，旨在用于与血液接触的医疗和牙科设备的分类， 管理设备与血液相互作用评估的基本原理， 根据具体类别进行结构化选择测试的依据，以及这些测试的原理和科学依据。 由于设备与血液的相互作用的测试的知识和精度的限制，无法指定测试的详细要求。 ISO 10993-4:2002总体描述生物学评估，可能不一定为特定装置的测试方法提供足够的指导

ISO 10993-4:2002 provides 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 as defined in ISO 10993-1, the fundamental principles governing the evaluation of the interaction of devices with blood, the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.