How to evaluate the safety performance of class II medical devices

Safety design of equipment, material quality, etc.

1, the safety design of the device: including the appearance of the device structure, electrical system, mechanical components and software programs, etc., the device is required to comply with national and industry standards, to avoid the existence of potential safety hazards.

2, the quality of materials: medical devices used in the material must comply with relevant national standards, such as toxic and hazardous substances content can not exceed the prescribed limits.