DIN EN ISO 10993-4-2007 医用装置的生物学评估.第4部分:与血液相互作用试验的选择
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006); German version EN ISO 10993-4:2002+A1:2006
This part of ISO 10993 provides general requirements for evaluating the interactions of medica devices with blood.
It describes
a) a classcification 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 evalutaion of the interaction of devices with blood,
c) the rationale for structured selectured selection of tests according to specific categories,together with the principles and scientific basis of these tests.
Detailed requirements for testing can not be specified because of the limitations in knowledge and precision of tests for interactions of devices with blood.Futher, this part of ISO 10993 describes biological evaluation in general terms and may not nectssarily 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 leves of specificity can only be covered in vertical standards.