This standard specifies the following test methods: a) Test methods for evaluating potential irritation of devices and their constituent materials; b) Test methods for evaluating potential sensitization of devices and their constituent materials; specified in GB/T 16886.1—ISO 10993-1 These test methods are recommended for most types of devices and body contact methods, and the tests listed in this standard can be selected according to the actual application of the device. This standard also specifies the material preparation requirements related to the above tests. Note 1: Appendix D provides supplementary test implementation guidelines applicable to oral, rectal, penile, and vaginal parts.
GB/T 16886.10-2000 history
2017GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
2005GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
2000GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization