医疗器械的生物评定.第4部分:与血液相互作用的试验的选择

[中文适用范围]： 本文件涉及血液。它描述了 a) 评估医疗设备与血液相互作用的一般要求，这些设备旨在接触血液，根据 ISO 10993-1 中定义的预期用途和接触时间进行分类；b) 治疗医疗设备与血液相互作用的基本原则；c) 根据特定类别选择结构化测试的原则，以及这些测试的原则和科学依据。由于在评估设备与血液相互作用的知识和精度有限，无法详细规定测试要求。本文件以一般性术语描述生物学评估，并不一定为具体设备的测试方法提供充分指导。本文件的更改并不表示根据先前版本进行的测试不再推荐。 marketed 设备有使用历史或临床用途时，可能需要额外测试。 [外文原描述]： 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.