ISO 10993-4:2002 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 10993-4:2002

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：2002-10

标准范围

ISO 10993-4:20 02提供了评价医疗器械与血液相互作用的一般要求。它描述了根据ISO 10993-1中定义的预期用途和接触持续时间，对预期用于与血液接触的医疗和牙科器械进行分类，评估器械与血液相互作用的基本原则，根据特定类别结构化选择试验的依据，以及这些试验的原则和科学依据。由于器械与血液相互作用检测的知识和精确度有限，无法规定检测的详细要求。ISO 10993-4:20 02笼统地描述了生物学评价，可能不一定为特定器械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

1. 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,
2. the fundamental principles governing the evaluation of the interaction of devices with blood,
3. 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.

标准预览图