Historical
GB/T 16886.1-2001
Biological evaluation of medical devices--Part 1: Evaluation and testing (TEXT OF DOCUMENT IS IN CHINESE)
The corresponding part in GB/T 16886 describes the following: a) General principles used to provide the guide to the biological evaluation of medical devices; b) Classification according to the contact property and time between devices and people. c) Selection of relative tests. The corresponding part in GB/T 16886 is not involved in the material and devices that contact with patients' bodies both not directly and not indirectly, and it is also not involved in the biological hazard caused by mechanical malfunction. The other parts in GB/T 16886-ISO 10993 include various particular tests as described in ISO introduction. (Referring to the specification in A2)
CHINESE GB Standards [spc]