BS EN ISO 10993-4-2009 医疗器械的生物评估.与血液相互作用的试验选择

标准号：BS EN ISO 10993-4-2009
中文标准名称：医疗器械的生物评估.与血液相互作用的试验选择
英文标准名称：Biological evaluation of medical devices - Selection of tests for interactions with blood
标准类型：C37
发布日期：2010/2/28 12:00:00
实施日期：2010/2/28 12:00:00
中国标准分类号：C37
国际标准分类号：11.100.20
引用标准：ISO 10993-1-1997;ISO 10993-2-1992
适用范围：This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describes a) 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 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. The selection and design of test methods should take into consideration device design, materials, clinical utility, usage environment and risk benefit. This level of specificity can only be covered in vertical standards.