標準號：DIN EN ISO 10993-4-2009
中文標準名稱：醫療設備的生物評估.第4部分:與血液相互作用試驗選擇(ISO 10993-4:2002,含修改件1:2006),DIN EN ISO 10993-4:2009-10的英文版本
英文標準名稱：Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); English version of DIN EN ISO 10993-4:2009-10
標準類型：C30
發布日期：1999/12/31 12:00:00
實施日期：2009/10/1 12:00:00
中國標準分類號：C30
國際標準分類號：11.100.20
適用范圍：This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describesa) 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,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 testsfor interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms andmay not necessarily provide sufficient guidance for test methods for a specific device.