Requirements for writing various contents of disinfection product labels and instructions
1. Those who have registered product trademarks should mark "##?", and those who apply for registration of product trademarks should mark "##TM". The remaining products are marked with "##brand".
The product names of disinfectants are: "## Skin and Mucous Membrane Disinfectant", "## Glutaraldehyde Disinfectant", "## Brand Trichloroisocyanuric Acid Disinfectant Tablets".
The product names of disinfection equipment include: "##RTP-50 tableware disinfection cabinet", "##TMYKX-2000 hospital linen sterilizer", "## brand CPF-100 chlorine dioxide generator" device".
The names of sanitary products include: "##TM contact lens care solution", "##TM antibacterial lotion for women", "## brand antibacterial lotion for women", etc.
The names of disinfection products with multi-purpose or multiple effective sterilization ingredients such as: "## (brand) disinfectant liquid (powder, tablets)" or "## (brand) YKX-2000 disinfection machine (device) "express.
2. Contents prohibited by this specification shall not be marked. For example, the following names do not comply with these regulations: "××medicated sanitary napkins", "××disinfectant wipes", "××antibacterial sanitary wipes" , "Condyloma External Disinfectant",
"××Bleipanjing", "××Scimetal", "××Bikangning", "××Bacterial Hand Sanitizer", "Almighty Duo" "Functional care solution", "XX full-function care solution" and "XX quick-acting sterilization full care solution", "XX
Eye drops", "XX eye care solution" and so on. [Dosage form, model]
Dosage forms of disinfectants and antibacterial agents such as: "liquid", "tablet", "powder", etc.; labeling of suppositories and soaps is prohibited.
The model number of sterilization equipment is such as "RTP-50 (type)", etc. [Main active ingredients and content]
1. Disinfectants and antibacterial (antibacterial) agents should be labeled with the main active ingredients and content; the active ingredients should be expressed by chemical names; the content should be labeled with product implementation standards. For example, glutaraldehyde disinfectant should be labeled "Glutaraldehyde, 2.0%~2.2% (W/W)"; trichloroisocyanuric acid disinfectant tablets should be labeled "Trichloroisocyanuric acid, containing Effective chlorine 45.0%~50.0%” (W/W); it can also be expressed in g/L.
2. Contact lens care products with disinfecting effect should be labeled with the main active ingredients and their content. The active ingredients should be expressed by chemical names; the content should be marked according to the range specified in the product implementation standards.
3. For plants or other products whose main active ingredients cannot be labeled, the names of the main raw materials should be labeled (for plants, the Latin names should be labeled) and the amount of the raw materials added per unit volume.
4. Disinfection products are prohibited from labeling antibiotics, hormones and other prohibited ingredients, such as "Metronidazole", "Adrenocortical Hormone", etc. [Approval number]
Refers to the document number approved by the health administrative department at or above the provincial level for a product and its manufacturing enterprise.
Manufacturing enterprise health license number: "(province, autonomous region, municipality abbreviation) Wei Xiao Zi (certificate year) No. XXXX", product health license approval number: "Wei Xiao Zi (year) No. XXXX", "Weixiao Jinzi (Year) No. XXXX".
Invalid approval document numbers shall not be marked, such as: (1996) × Weixiaozhunzi No. XXXX. [Execution standards] Product implementation standards should be currently valid standards, expressed by the standard number, such as "GB15979", "Q/HJK001", etc. The year number of the standard does not need to be marked.
Enterprise standards should comply with the requirements of relevant national regulations, standards and specifications.
[Category of killing microorganisms]
1. It should be stated in accordance with the relevant provisions of the "Technical Specifications for Disinfection" of the Ministry of Health. If it has inhibitory and killing effects on indicator microorganisms, it should be marked in the product instructions that it has inhibitory and killing effects on the types of microorganisms it represents.
For example, if the killing rate of Staphylococcus aureus is ≥99.999%, it can be labeled as “killing pyogenes”; if it has an inactivating effect on poliovirus, it can be labeled as “inactivating viruses” "Function";
2. It is prohibited to label various disease names and disease symptoms, such as "psoriasis", "neurodermatitis", "seborrheic dermatitis", etc.
3. It is prohibited to label antimicrobial/microbicidal categories without inspection basis, such as "condyloma acuminata virus", "SARS virus", etc.
[Scope of use and method of use]
1. The method of using the product should be listed clearly and in detail. If there are more than two methods of use, it is recommended to use a table.
2. Disinfectants, antibacterial (anti)bacterial agents, and contact lens care products should be labeled with the target of action, the action concentration (expressed by the content of active ingredients), the preparation method, and the action time (based on the antibacterial ring test) The test method does not need to indicate the time (time), mode of action, and treatment methods after disinfection or sterilization. Disinfectants used on mucous membranes should be labeled “for diagnosis and treatment in medical and health institutions only”.
For example: The scope of use of glutaraldehyde disinfectant is "suitable for disinfection and sterilization of medical equipment"; the method of use is "① Add the A agent (sodium bicarbonate) that comes with this product before use, and stir thoroughly. Dissolve evenly; then add the included agent B (sodium nitrate) to dissolve and mix. ② Disinfection method: Wipe and soak the disinfected items with the original solution for 20min~45min. ③ Sterilization method: Soak in the original solution until sterilized. 10h for sterilized items. ④ Disinfected and sterilized medical devices must be rinsed with sterile water before use."
3. Disinfection equipment should be labeled with the target of action, bactericidal factor intensity, action time, mode of action, and treatment methods after disinfection or sterilization. For example, the scope of use of the tableware disinfection cabinet is "disinfection and cleaning of tableware (drinking) tableware"; the usage method
"Place the washed and drained tableware on the shelf in an orderly manner; press the power button and disinfection button button, the indicator light will turn on at the same time; after one cycle of action, the disinfection indicator light will go out, indicating that the disinfection is completed. ”
4. It is prohibited to label the use objects without inspection basis, words similar to drugs, and nothing in the usage instructions. The dosage and objects used according to the test, such as "X times a day", "XX days as a course of treatment, or as directed by the doctor", etc.
[Notes]
This item includes product storage conditions, usage protection and usage contraindications. For products that may endanger human health and personal and property safety during use, there should be warning signs or Chinese warning instructions.
[Production date, validity period or shelf life] The production date should be expressed in the form of "year, month, day" or "20050903". The shelf life and validity period should be expressed in the form of "X years or XX months".
[Production batch number and expiration date] The form of production batch number is determined by the enterprise. The limited use date should be expressed in the form of "please use it before XXXX year XX month" or "valid until XXXX year XX month".
[Service life of main components] This item should indicate the service life or replacement time of the components that produce bactericidal factors in the disinfection equipment.
The service life should be expressed in terms of "X years or XXXX hours".
[Manufacturer and its hygiene license number] The name and address of the manufacturing enterprise should be consistent with the hygiene license of its disinfection product manufacturing enterprise.
If the production and processing is entrusted, the name and address of the product responsible unit (the entrusting party) and the name and health license number of the actual production and processing enterprise (the entrusted party) must be marked at the same time.
Although it does not belong to entrusted production and processing, when the information of the product responsible unit and the actual production and processing enterprise are different, the information of the product responsibility unit and the information of the actual production and processing enterprise should be marked respectively. For example, the responsible unit is the head office, and the actual production and processing enterprise is one of its subordinate enterprises.