? Enterprise production license + product record or approval
2 Definitions
? Disinfection products: including disinfectants, disinfection instruments (including biological indicators, chemical indicators and packaging for sterilized articles), sanitary products and single-use medical supplies
? New disinfection products: refers to the use of new materials, new technology and new sterilization principles of disinfectants and disinfection devices
3 Classification of disinfection products
? The first category is a high risk, need to be strictly managed to ensure the safety and effectiveness of disinfection products, including high-level disinfectants and disinfecting instruments used for medical devices, sterilizers and sterilizing instruments, skin and mucous membrane disinfectants, bio-indicators and chemical indicators of sterilization effect
? The second category is a moderate risk, need to strengthen the management to ensure the safety and effectiveness of disinfection products, including in addition to the first category of products, disinfectants, disinfecting instruments, as well as anti-bacterial (inhibitory) preparations
? The third category is a lower degree of risk, the implementation of routine management can ensure the safety and effectiveness of sanitation products in addition to anti-(antibacterial) preparations.
? Note: the same disinfection products involving different categories, should be managed in the higher risk category.
4 Manufacturer health license validity
? The license is valid for four years
5 Production items
? Disinfectants, disinfecting instruments, sanitary products
6 Classified directory of production categories
? 6.1 Disinfectants
Powder disinfectants.
Tablet disinfectants.
Granular disinfectants.
Liquid disinfectants.
Spray disinfectants.
Gel disinfectants.
For the purification requirements, after the corresponding category, indicate "(purification)".
? 6.2 Disinfecting instruments
Pressure steam sterilizer.
Ethylene oxide sterilizer.
Glutaraldehyde sterilization cabinet.
Plasma sterilizer.
Ozone sterilizer.
Electrothermal sterilizer.
Electrostatic air sterilizer.
Ultraviolet germicidal lamp.
Ultraviolet sterilizer.
Formaldehyde sterilizer.
Acid oxidation potential water generator.
Sodium hypochlorite generator.
Chlorine dioxide generator.
Ozone generator, ozone water generator.
Other disinfecting instruments (indicating the sterilization factor).
Biological indicators for determining the effect of pressure steam sterilization.
Biological indicators for the determination of ethylene oxide sterilization.
Biological indicators for the determination of the effect of ultraviolet sterilization.
Bioindicators for the determination of dry heat sterilization.
Bioindicators for the determination of formaldehyde sterilization.
Bioindicators for the determination of sterilization by ionizing radiation.
Bioindicators for the determination of the effect of plasma sterilization.
Chemical indicators for the determination of pressure steam sterilization (indicator cards, indicator tape, indicator labels, BD
test strips, BD kits).
Chemical indicators for the determination of ethylene oxide sterilization (indicator cards, indicator tape, indicator labels).
Chemical indicators for the determination of UV sterilization (irradiation intensity indicator card, disinfection effect indicator card).
Chemical indicators for determining the effect of dry heat sterilization.
Chemical indicators for the determination of the sterilization effect of ionizing radiation.
Chemical indicator for determining the concentration of chemical disinfectants.
Chemical indicator for determining the effect of plasma sterilization.
Packaging for pressure steam sterilization with sterilization marking.
Packages for ethylene oxide sterilization with a sterilization mark.
Packaging for formaldehyde sterilization with the sterilization mark.
Packages for plasma sterilization with the sterilization mark.
? 6.3 Sanitary products
Sanitary napkins, sanitary pads.
Sanitary pessary (built-in tampon).
Diapers.
Diapers (pads, paper).
Diaper pads.
Wet wipes, hygiene wipes.
Anti-bacterial preparations (except suppositories, soaps) (specify the type of preparation).
Contact lens care solution.
Contact lens preservation solution.
Contact lens cleaner.
Tissue (paper).
Tampons (sticks, swabs, balls).
Tissue pads (paper, wipes).
Hand (finger) covers.
Paper eating utensils.
For those with decontamination requirements, indicate "(decontamination)" after the corresponding category.
7? Sterilization product qualification requirements
8 License / report style
? 8.1?Health license for product manufacturers
8.2?Health and safety assessment report
8.3?A copy of the record certificate
Appendix: Cited Documents
1? Disinfection Management Measures (2002-07-01)
2? Sanitary Supervision of Disinfected Products Work Specification (2014-07-03)
3. sanitary license regulations for the production of disinfection products