ISO 10993-4:2017 医疗装置生物学评定 第4部分：与血液相互作用试验选择

标准编号：ISO 10993-4:2017

中文名称：医疗装置生物学评定 第4部分：与血液相互作用试验选择

英文名称：Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

发布日期：2017-04

标准范围

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。它描述了a） 根据ISO 10993-1中定义的预期用途和接触持续时间，对用于接触血液的医疗设备进行分类，b） 评估设备与血液相互作用的基本原则，c） 根据特定类别对测试进行结构化选择的基本原理，以及这些测试的原则和科学依据。由于评估设备与血液相互作用的测试在知识和精度方面的局限性，无法规定测试的详细要求。本文件概述了生物评估，但不一定能为特定设备的测试方法提供足够的指导。本文件中的变更并不表明根据本文件之前版本进行的测试无效。对于有安全临床使用史的上市设备，不建议根据本修订进行额外测试。

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.It describesa) 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.

标准预览图