NMPA has supervised the product quality for various devices and has found that some products did not comply with the requirements, including:
1. Electric wheelchairs: The minimum radius of gyration, restriction when charging, maximum speed, braking on level road, and braking on the maximum slope do not comply with the requirements.
2. Insufflator: The continuous leakage current at normal operating temperature does not comply with the requirements.
3. Metal spine rod: The surface roughness does not comply with the requirements.
4. Metal bone plate: The strength and stiffness of bending does not comply with the requirements.
5. Nd:YAG laser treatment equipment: The accuracy of control components and laser terminal pulse energy do not comply with the requirements.
6. Gynecological ultrasound diagnostic equipment: The tolerance of detection depth and blood flow velocity do not comply with the requirements.
7. Portable X-ray equipment: The input power, half-value layer of X-ray equipment and the distance from the focal point to the skin do not comply with the requirements.
8. Dental implant equipment: The no-load speed does not comply with the requirements.
9. Disposable abdominal trocar: The sealing performance and matching performance do not comply with the requirements.
10. Surgical gown: The bursting strength, tensile strength, and resistance of microbial penetration do not comply with the requirements.
11. Disposable blood collection container: The nominal liquid capacity, scale marks and sterility do not comply with the requirements
12. Cold light source for endoscope: The continuous leakage current at normal operating temperature, the input power, the sample cannot be operated normally during the inspection, the correlated color temperature and the radiant flux ratio of red, green and blue light do not comply with the requirements.
Further details can be found in the attachment.
Attachment:
- 1. List of nonconformity products