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GB/T 16886.4-2003
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood (TEXT OF DOCUMENT IS IN CHINESE)
This part of GB/T 16886 provides general requirements for evaluation of medical devices' interactions with blood. This part of GB/T 16886 establishes:
Limited by the knowledge of interactions of devices and blood as well as limited by the accuracy of tests, specific test requirements cannot be established. Therefore, this part of GB/T 16886 only provides a general description of biological evaluation but does not provide a guideline on test methods for specific devices.
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CHINESE GB Standards [spc]