In addition to developing the corresponding physical and chemical requirements in product technical requirements according to the product characteristics, the administrative counterpart should also simulate the actual clinical use conditions to verify the declared special properties. The verification test should at least consider product design, intended use, use method, service life and other aspects so as to develop the test method suitable for the product under application based on product characteristics. In the process of developing a test protocol, at least the following should be considered:
- The test procedure should be consistent with actual clinical practice;
- The selection of test conditions should cover the situations that may be involved in the clinical settings;
- The sample size should be able to reflect the scientific of test;
- The number of verification should be more than the number of uses declared for the product;
- Other relevant guidance documents, etc.
