Historical

GB/T 16886.10-2000

Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization (TEXT OF DOCUMENT IS IN CHINESE)

This standard provides the following test methods:

a) The test method for evaluation of potential irritation of devices and materials which devices are made of.

b) The test method for evaluation of potential sensitization of devices and materials which devices are made of.

These test methods are recommended to most types of and body-contact apparatus defined in GB/T 16886.1-ISO 10993-1. Tests listed in this standard can be chosen according to practical application of devices. This standard also specifies requirements for preparation of the materials related to the above test.

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CHINESE GB Standards [spc]

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