Disinfection Product Specifically Introduced
Classes are of high risk and require strict management to ensure safe and effective disinfection product, including high levels of disinfectants and disinfectants for medical devices, sterilizers and sterilizers, skin and mucous membrane disinfectants, biological indicators And chemical effects of sterilization.
Classes are moderately risky and need to be managed to ensure safe and effective disinfection product, including disinfectants, disinfectants, and antiples (f) in addition to the first category of products.
Class is a low degree of risk, the implementation of routine management can ensure safe and effective in addition to anti-(anti) bacteria preparations outside the health supplies.
Disinfection product production and management requirements ~
Disinfection product manufacturers should obtain health permits before production.
Disinfection product business, the use of units should be established disinfection product purchase inspection and acceptance system; to obtain domestic disinfection product production enterprises health permits, disinfection product, health permits or health safety assessment report; check the name of disinfection product, production enterprises or responsibility in China, the name and Disinfection product label (nameplate), manual;
The naming and labeling of disinfected products shall be in accordance with the relevant provisions of the National Health Commission. The label (including the instructions) and the promotional content of the disinfected product must be true and shall not appear or imply a therapeutic effect on the disease.
Prohibit the production and operation of the following disinfection product:
(1) the hygienic license of the non-production enterprise or the approval document of the sanitary permit for the new disinfection product;
(2) product health safety evaluation failed or product health quality does not meet the requirements.
What is the hygiene supervision of disinfection product?
Disinfection product health supervision refers to the local health administrative departments above the county level and its comprehensive supervision and law enforcement agencies based on "infectious disease prevention and control law", "disinfection management approach" and other relevant laws and regulations, the disinfection of production enterprises, import disinfection product in China Responsible units and the operation of disinfection product, the use of units for health supervision and inspection activities.
Disinfection product to monitor health supervision
According to the "Beijing 2016 disinfection of health products supervision and inspection of the implementation of the program," the deployment requirements, Dongcheng District Health Bureau health supervision combined with the specific work of the area, the development of 2016 disinfection product, health supervision focus inspection work plan, and orderly related jobs. According to the "health-related products, national health supervision and sampling requirements" requirements, the area of operation, the use of units operating the use of disinfection product to carry out supervision and sampling; on the area of disinfection product manufacturing enterprises, operators, the use of units to carry out special supervision and inspection. On the discovery of substandard products according to the law and investigate and notify the province where the production enterprises in the health sector, the source control.