標準號：BS EN ISO 10993-4-2009
中文標準名稱：醫療器械的生物評估.與血液相互作用的試驗選擇
英文標準名稱：Biological evaluation of medical devices - Selection of tests for interactions with blood
標準類型：C37
發布日期：2010/2/28 12:00:00
實施日期：2010/2/28 12:00:00
中國標準分類號：C37
國際標準分類號：11.100.20
引用標準：ISO 10993-1-1997;ISO 10993-2-1992
適用范圍：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.