Preclinical testing refers to the various types of bench testing that are conducted during product development to ensure the safety and performance of product design, which includes: testing of function, electrical safety, electromagnetic compatibility, biocompatibility, sterilization validation, etc.

Final quality control testing is the testing of final product before it is released from the factory. The report format and content of such testing will vary depending on the different original manufacturers and products, typically covering test items such as product appearance, dimension, basic safety test, and functional test.

Complete test data should include: test items, test specifications, test methods, test results, acceptable range, and basis for the testing. Among which, the content of test results should indicate the product name, specifications (model), manufacturer’s name, address, and signature of testing personnel.

If the product already has standards or guidances applicable, please provide reports for the tests conducted according to these standards or guidances. This may greatly reduce the possibility of insufficient test data.

Laboratories commissioned to conduct the tests of biocompatibility, electrical safety, electromagnetic compatibility, and sterilization validation shall meet one of the following criteria:

1. Conform to the requirements of ISO/IEC 17025.
2. Conform to the requirements of Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies.