Disposable sanitary materials belong to the medical sanitary materials and dressings; it belongs to the second class of medical devices.
The second class of medical devices are: operating room, emergency room, diagnostic and treatment room equipment and appliances; stomatology equipment and appliances; ward care equipment and appliances; disinfection and sterilization equipment and appliances; medical cold therapy, cryogenic, refrigeration equipment and appliances; stomatology materials; medical hygiene materials and dressings; medical suture materials and adhesives; medical polymer materials and products; software; interventional equipment and so on.
Engaged in medical device business activities, there should be with the scale and scope of business operations and storage conditions, as well as with the operation of the medical device quality management system and quality management organizations or personnel.
Expanded:
Disposable sanitary material use requirements stipulate:
1, the establishment of sterile instruments after use destruction system. Used sterile instruments must be destroyed in accordance with the provisions of the parts and components no longer have the use of function due to disinfection and harmless disposal, and make a record.
2, the establishment of aseptic instrument procurement, acceptance system, strict implementation and good records. Purchase and acceptance records should at least include: the name of the company purchasing the product, product name, model specifications, the number of products, production batch number, sterilization batch number, product expiration date.
3, if found unqualified sterile instruments, should immediately stop using, sealed, and timely contact with the manufacturer to be replaced. Suspected adverse events occurring in the use of sterile devices should be reported to the provincial medical device adverse event monitoring center in accordance with the provisions of the timely.
Baidu Encyclopedia - Class II Medical Devices