DIN EN ISO 10993-4-2017 医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO 10993-4-2017);德文版本EN ISO 10993-4-2017

标准号：DIN EN ISO 10993-4-2017
中文标准名称：医疗设备的生物评估.第4部分:与血液相互作用试验选择(ISO 10993-4-2017);德文版本EN ISO 10993-4-2017
英文标准名称：Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
国际标准分类号：11.100.20
引用标准：DIN EN ISO 3826-3-2008;DIN EN ISO 5840-1-2015;DIN EN ISO 5840-2-2016;DIN EN ISO 5840-3-2013;DIN EN ISO 7199-2017;DIN EN ISO 8637-2014;DIN EN ISO 10993-1-2010;DIN EN ISO 10993-2-2006;DIN EN ISO 10993-3-2015;DIN EN ISO 10993-4-2009;DIN EN ISO 10993-5-2009;D
适用范围：This document provides 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 the limitations in knowledge and precision of tests for interactions of devices with blood. Further, this part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.