ISO 10993-4:2017规定了评估医疗器械与血液相互作用的一般要求。 它描述 a）根据ISO 10993-1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设备的分类， b）设备与血液相互作用评估的基本原则， c）根据具体类别结构选择测试的依据，以及这些测试的原理和科学依据。 测试的详细要求不能被指定，因为用于评估装置与血液的相互作用的测试的知识和精度的限制。本文件总体上描述了生物学评估，并且可能不一定为特定设备的测试方法提供足够的指导。 本文档中的更改不表示根据本文档的先前版本进行的测试无效。对于具有临床使用安全性的市售设备，不建议根据本修订进行附加测试

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical 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. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.