On What Conditions Can Surgical Instruments Be Exempted From Biological Tests？

Based on the current level of knowledge, biological tests can be exempted if the following conditions are satisfied:

• Material chemical composition verification data are provided.
• The production process does not affect the chemical composition of the material, verification data can be submitted in the form of a material list of raw materials.
• Materials in surgical instruments that come into contact with patients (directly or indirectly) are only composed of metals.
• Metal materials are verified to meet the relevant national, industrial and international standards for metallic materials for surgical implants or materials for surgical instruments, as well as the brand specified in applicable national and industrial standards for specific products. For example, the material brand specified in YY/T 0176 General Technical Conditions for Medical Scissors.