Under what circumstances can surgical instruments be exempted from biological tests?

Based on the current level of cognition, if the materials directly or indirectly contacting patients in surgical instrument products only consist of metal materials, which are verified to conform to the relevant national, industrial and international standards for metal materials for surgical implants or materials for surgical instruments, and the brands specified in the relevant national and industrial standards for products (such as the material brands specified in YY/T 0176 General Technical Conditions for Medical Scissors), The biological test can be exempted if the verification data of the chemical composition of the material is provided (if it is proved that the production process does not affect the chemical composition of the material, it can be submitted in the form of raw material list).

By Center for Medical Device Evaluation. NMPA

Translated & edited  | Bradyknows