This part of GB/T 16886 gives the general requirements for the evaluation of the interaction between medical devices and blood. This part of GB/T 16886 specifies: a) classification of medical and dental devices that come into contact with blood according to the intended use and contact time specified in GB/T 16886.1/IS0 10993-1; The evaluation principles; c) the principles for selecting a given test according to the specific device classification, taking into account the test rationale and scientific basis. Due to the limited understanding of the interaction between the device and blood and the accuracy of the test, detailed test requirements cannot be specified. Therefore, this part of GB/T 16886 is only a general description of the biological evaluation, and does not provide test methods for specific devices. guide.
GB/T 16886.4-2003 history
2022GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
2003GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood