How to identify a class, two types of medical equipment?
1. Look at the logo on the product nameplate
2. "Medical device product registration management approach" is provided
The following products are included in the third category:
1. All implanted human products (regardless of what kind of biological materials used); 2. Radiation treatment equipment; 3. Respiratory anesthesia equipment; 4. Cardiopulmonary bypass equipment; 5. X-ray CT, MRI, ultrasound CT, positron CT , Single photon CT; 6. contact with the body blood or body blood of the polymer materials, medical equipment with interventional treatment equipment, ultrasound imaging equipment with the implantation of human products; 7. oxygen treatment cabin, baby incubator as Life support products; 8. Heart and vascular endoscopy, radioactive radiation diagnostic equipment as potential dangerous products; 9. Simulation of auxiliary equipment as a potential danger of special cases.
Two categories:
The fifth
This "catalog" will be divided into two parts of medical equipment, that is, equipment and equipment, equipment, materials category. The utensil category "this catalog" lists only the first class of appliances and the third category of appliances, the second category of equipment is not listed. Belong to 6801-6819 various types of products, in addition to implanted in the human body, disposable polymer products, new varieties, energy products, are naturally classified as the second category. 6846 - Function Aids - Hearing aids are the second category.
(That is, similar to the ECG and the like)
one type:
There are directories
(Note: Because of the various components of the surgical package is not sure, so this catalog does not contain such products. Where the surgical package contains Class III medical devices, as a class III product management; only contain Class II and Class I medical devices, As a class II product management; only contain Class I medical devices, as a Class I product management.)
A class and two categories, only need to see the first letter of medical device registration number, 1 on behalf of a class, 2 on behalf of the second category.
The difference between class and class 2:
Article 5 The State shall classify and administer medical devices.
The first category refers to medical devices that are routinely managed enough to ensure their safety and effectiveness.
The second category refers to the medical device whose safety and effectiveness should be controlled.
The third category refers to the implantation of the human body; used to support, maintain life; the human body is potentially dangerous, its safety, effectiveness must be strictly controlled medical equipment.
