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Disinfection products label specification management specification disinfection products label specification management specification.
The relevant contents marked on the labels and instructions of disinfection products shall be true, and there shall be no contents that falsely exaggerate, express or imply the therapeutic effect and effect on diseases, and meet the following requirements:

(a) the Chinese logo should be used, and if there is a foreign logo, its display content must comply with the provisions of relevant state regulations and standards.

(2) The product name shall conform to the naming regulations of the Ministry of Health on health-related products, including brand name, common name and attribute name; Disinfection products with a variety of disinfection or antibacterial (bacteriostatic) purposes or containing a variety of effective bactericidal ingredients can be named only by brand name (or brand name) and attribute name.

(3) The name, dosage form, model, approval number, content of effective components, scope of use, method of use, validity period/term of use of disinfectants and disinfection devices shall be consistent with the hygiene license or filing of the health administrative department at or above the provincial level; The content of the main effective components of health products should conform to the scope stipulated in the product implementation standards.

(four) the implementation standards of product identification shall conform to the national standards, industry standards, local standards and relevant norms. Enterprise standards for labeling domestic products shall be filed according to law.

(five) the category of killing microorganisms should be expressed in accordance with the relevant provisions of the Technical Specification for Disinfection of the Ministry of Health; The categories of killing microorganisms approved by the Ministry of Health in disinfection products should be consistent with those approved by the Ministry of Health; Disinfection products without the approval of the Ministry of Health shall be consistent with the inspection report issued by the disinfection products inspection agency approved by the health administrative department at or above the provincial level.

(six) disinfection products has special requirements for safe storage and transportation conditions, which should be clearly indicated in the product identification.

(seven) when labeling the information of the production enterprise, the information of the responsible unit of the product and the information of the actual production and processing enterprise of the product should be labeled at the same time (when the two are the same, there is no need to repeat the labeling).

(8) The marked hygiene license number of the production enterprise shall be the hygiene license number of the actual production enterprise. The minimum sales package in disinfection products shall be printed or marked clearly and firmly, and shall not be altered.

Disinfectants, disinfection equipment, antibacterial agents and contact lens care products should be accompanied by instructions. If the product label already includes instructions, additional instructions are not needed. The label of disinfectant package (except minimum sales package) shall indicate the following contents:

(1) product name;

(two) the approval number of the product hygiene license;

(3) Production enterprise (name and address);

(four) the hygiene license number of the production enterprise (except for imported products);

(five) the name of the country or region of origin (except domestic products);

(6) Date of production and period of validity/production batch number and date of use restriction. The minimum sales package label of disinfectant shall be marked with the following contents:

(1) product name;

(two) the approval number of the product hygiene license;

(3) Production enterprise (name and address);

(four) the hygiene license number of the production enterprise (except for imported products);

(five) the name of the country or region of origin (except domestic products);

(six) the main effective components and their contents;

(seven) the date of production and the period of validity/production batch number and the date of use restriction;

(8) Disinfectants used for mucous membranes should also be marked "for medical and health institutions only". Disinfectant instructions should indicate the following contents:

(1) product name;

(two) the approval number of the product hygiene license;

(3) dosage forms and specifications;

(4) Main effective components and their contents;

(5) Types of microorganisms to be killed;

(six) the scope and method of use;

(7) Precautions;

(eight) the implementation of the standard;

(9) Production enterprise (name, address, telephone number and postal code);

(ten) the hygiene license number of the production enterprise (except for imported products);

(eleven) the name of the country or region of origin (except domestic products);

(12) period of validity;

(thirteen) mucosal disinfectant should also be marked "for medical and health institutions only". The label of disinfection equipment packaging (except minimum sales packaging) shall be marked with the following contents:

(1) product name and model;

(two) the approval number of the product hygiene license;

(3) Production enterprise (name and address);

(four) the hygiene license number of the production enterprise (except for imported products);

(five) the name of the country or region of origin (except domestic products);

(6) Date of production;

(seven) the period of validity (limited to biological indicators, chemical indicators and aseptic packaging, etc.). );

(eight) transportation and storage conditions;

(9) Precautions. The minimum sales package label or nameplate of disinfection equipment shall indicate the following contents:

(1) product name;

(two) the approval number of the product hygiene license;

(3) Production enterprise (name and address);

(four) the hygiene license number of the production enterprise (except for imported products);

(five) the name of the country or region of origin (except domestic products);

(6) Date of production;

(seven) the validity period (limited to biological indicators, chemical indicators and aseptic packaging);

(8) Precautions. The instructions for disinfection instruments shall indicate the following contents:

(1) product name;

(two) the approval number of the product hygiene license;

(3) Model and specification;

(four) the main bactericidal factors and their intensity, bactericidal principle and categories of killing microorganisms;

(5) Scope and method of use;

(6) service life (or service life of main components);

(7) Precautions;

(eight) the implementation of the standard;

(9) Production enterprise (name, address, telephone number and postal code);

(ten) the hygiene license number of the production enterprise (except for imported products);

(eleven) the name of the country or region of origin (except domestic products);

(12) Validity period (limited to biological indicator, chemical indicator and sterilization package, etc. ). The label of sanitary products packaging (except minimum sales packaging) shall indicate the following contents:

(1) product name;

(2) Production enterprise (name and address);

(three) the hygiene license number of the production enterprise (except for imported products);

(four) the name of the country or region of origin (except domestic products);

(5) Storage conditions that meet the product characteristics;

(six) the date of production and shelf life/production batch number and date of use restriction;

(seven) the disinfection grade of sanitary products should be marked with the words "disinfection grade", disinfection method, disinfection batch number/disinfection date, validity period/limited use date, etc. The minimum sales packaging label of sanitary products shall be marked with the following contents:

(1) product name;

(2) Names of main raw materials;

(3) production enterprise (name, address, contact number and postal code);

(four) the hygiene license number of the production enterprise (except for imported products);

(five) the name of the country or region of origin (except domestic products);

(six) the date of production and the period of validity (shelf life)/production batch number and the date of use restriction;

(seven) disinfection grade products should be marked with the words "disinfection grade";

(eight) sanitary wipes should also be marked with bactericidal active ingredients and their contents, methods of use, scope of use and precautions. The minimum sales package label of antimicrobial (bacteriostatic) preparations shall indicate the contents stipulated in Article 13 of this specification, as well as the effective components and contents of the main raw materials of the product; Antibacterial (bacteriostatic) preparations containing plant components shall also be marked with the Latin scientific names of the main plants; If the killing rate of indicator bacteria is greater than or equal to 90%, it can be marked as "sterilization"; If the bacteriostatic rate of indicator bacteria reaches 50% or the diameter of bacteriostatic circle is greater than 7mm, it can be marked as "bacteriostatic"; If the bacteriostatic rate is greater than or equal to 90%, it can be marked as "having strong bacteriostatic effect".

Antibacterial (bacteriostatic) products used for pudendal mucosa should be marked as "not used for preventing sexually transmitted diseases in sexual life". The instructions for antimicrobial (inhibitory) preparations shall indicate the following contents:

(1) product name;

(2) Specifications and dosage forms;

(3) The main effective components and their contents, and the Latin scientific names of the main plants shall indicate the antibacterial drugs of the plant components;

(4) inhibiting or killing microbial species;

(5) Production enterprise (name, address, telephone number and postal code);

(six) the hygiene license number of the production enterprise (except for imported products);

(seven) the name of the country or region of origin (except domestic products);

(eight) the scope and method of use;

(9) Precautions;

(10) implementation standard;

(eleven) production date and shelf life/production batch number and date of use. The instructions for contact lens care products shall be marked with the following contents:

(1) product name;

(2) Specifications and dosage forms;

(3) production enterprise (name, address, contact number and postal code);

(four) the hygiene license number of the production enterprise (except for imported products);

(five) the name of the country or region of origin (except domestic products);

(six) the scope and method of use;

(7) Precautions;

(eight) the implementation of the standard;

(9) Production date and shelf life/production batch number and limited use date.

Contact lens care products with disinfection function should also be marked with the main effective components and contents for killing microorganisms. Disinfection products labels and instructions prohibit the following contents:

(a) sanitary napkins (paper) and other products are prohibited from labeling disinfection, sterilization, disinfection, medicine, health care, dehumidification, moistening dryness, relieving itching, diminishing inflammation, spermicide, contraception and antibacterial (bacteriostatic) effects without inspection basis;

(2) Sanitary wipes, wet wipes and other products are prohibited to be labeled with disinfection, sterilization, drugs, high efficiency, non-toxicity, prevention of sexually transmitted diseases, treatment of diseases, alleviation or alleviation of disease symptoms, anti-inflammatory and anti-inflammatory, and users have no inspection basis and shelf life. Sanitary wipes should also be prohibited from labeling microbial inhibition/killing categories without inspection basis and antibacterial (bacteriostatic) effects without inspection basis. Wet wipes should also be prohibited from being marked with anti-/bacteriostatic and bactericidal functions;

(3) Anti-(bacteriostatic) agent products are prohibited from labeling prohibited ingredients such as high efficiency, non-toxicity, disinfection, sterilization, disinfection, anti-inflammation, treatment of diseases, alleviation or alleviation of disease symptoms, prevention of sexually transmitted diseases, spermicide, contraception, antibiotics and hormones; It is forbidden to mark the dosage and objects without inspection basis, the categories of inhibiting/killing microorganisms without inspection basis, the validity period without inspection basis and the antibacterial (inhibiting) effect without inspection basis; It is forbidden to mark feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectal and other specific parts of the human body; Anti-(bacteriostatic) products are prohibited from labeling damaged skin, mucosa, wounds, etc.

(4) Contact lens care products are forbidden to be marked with the words full-function, high-efficiency, non-toxic, sterilization or disinfection, and it is forbidden to mark the disinfection and antibacterial (bacteriostatic) effects without inspection basis, as well as the dosage and shelf life without inspection basis;

(5) Disinfectants are prohibited from labeling prohibited ingredients such as broad spectrum, quick-acting, non-toxic, anti-inflammatory, anti-inflammatory, disease treatment, alleviation or alleviation of disease symptoms, prevention of sexually transmitted diseases, spermicide, contraception, antibiotics and hormones; It is forbidden to mark the scope of use, dosage and method without inspection basis, and the category and validity period of killing microorganisms without inspection basis; It is forbidden to label feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectal and other specific parts of the human body;

(6) It is forbidden to indicate the invalid approval number or license number, disease symptoms and disease name on the label and instruction manual of disinfection products (except when the disease name is part of the name of microorganism, such as "poliovirus"). The meanings of the following terms in this specification:

Disinfection products: It includes disinfectants, disinfection instruments (including biological indicators, chemical indicators and packaging materials of sterilized articles) and sanitary products.

Label: refers to all marks on the minimum sales package and other packages of the product.

Instruction: refers to all the relevant words, videos, patterns and other materials attached to the product sales package.

Sterilization: the treatment of killing or removing all microorganisms on the medium.

Disinfection: kill or remove pathogenic microorganisms on the media, so as to achieve harmless treatment.

Antibacterial: the process of killing bacteria or hindering their growth, reproduction and activity by chemical or physical means.

Bacteriostasis: the process of inhibiting or hindering the growth, reproduction and activities of bacteria by chemical or physical means.

Contact lens care products refer to solutions or soluble solid preparations that are specially used for contact lens care and have the functions of cleaning, disinfecting, washing or preserving lenses, neutralizing detergents or disinfectants, and physically relieving (or lubricating) eye discomfort caused by contact lenses.

Sanitary wet wipes: in particular, it refers to the wet wipes with sterilization function that meet the Hygienic Standard for Disposable Sanitary Articles (GB 15979). The killing rate of Escherichia coli and Staphylococcus aureus is ≥90%. If it is indicated that it has an effect on fungi, the killing rate of Candida albicans should be greater than or equal to 90%, and its bactericidal effect should be maintained at room temperature for at least 65438 0 years.

Disinfection-grade sanitary products: sanitary products that have been treated by effective disinfection methods such as ethylene oxide, ionizing radiation or pressure steam and meet the disinfection grade requirements specified in the Hygienic Standard for Disposable Sanitary Products (GB 15979).

Product liability unit: refers to a legal entity that is legally liable for personal injury or property loss caused by product defects. When entrusting production and processing, it refers to the entrusting party. This specification came into effect on May 1 day, 2006. The Ministry of Health shall be responsible for the interpretation of these Provisions.

Attachment: Writing requirements for all contents of disinfection products labels and instructions (omitted)