The relevant content marked on the labels and instructions of disinfection products should be true, and should not contain any content that falsely exaggerates, expresses or implies the therapeutic effects on diseases, and meets the following requirements:

( 1) Chinese logos should be used. If there are foreign language logos, the display content must comply with relevant national regulations and standards.

(2) The product name should comply with the "Regulations on Naming Health-Related Products of the Ministry of Health" and should include the trademark name (or brand name), common name, and attribute name; there are many types of disinfection or antibacterial (anti)bacterial For disinfection products that are intended for use or contain multiple effective bactericidal ingredients, only the trademark name (or brand name) and attribute name can be marked when naming.

(3) The name, dosage form, model, approval number, active ingredient content, scope of use, method of use, validity period/service life, etc. of disinfectants and disinfection equipment should be consistent with the health administrative department at or above the provincial level. The content of the main active ingredients of sanitary products should be consistent with the scope of product implementation standards.

(4) The implementation standards for product labeling should comply with national standards, industry standards, local standards and relevant regulations. Enterprise standards for labeling domestic products should be filed in accordance with the law.

(5) The categories of microorganisms killed should be stated in accordance with the relevant provisions of the "Technical Specifications for Disinfection" of the Ministry of Health; the categories of microorganisms killed by disinfection products approved by the Ministry of Health should be consistent with those approved by the Ministry of Health in the health license ; For disinfection products that have not been approved by the Ministry of Health, the category of microorganisms killed should be consistent with the inspection report issued by the disinfection product inspection agency recognized by the health administrative department at or above the provincial level.

(6) If disinfection products have special requirements for storage, transportation conditions, safety, etc., these should be clearly stated in the product label.

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

(8) The health license number of the production enterprise marked should be the actual production enterprise health license number. The minimum sales package of disinfection products should be printed or labeled, which should be clear, firm, and cannot be altered.

Disinfectants, sterilizing equipment, antibacterial agents, and contact lens care products should be accompanied by instructions. If the product label content already includes the instructions, separate instructions are not required. The label of the disinfectant package (except the minimum sales package) should be marked with the following content:

(1) Product name;

(2) Product health license approval number;

(3) Manufacturing enterprise (name, address);

(4) Hygiene license number of the manufacturing enterprise (excluding imported products);

(5) Name of country or region of origin (Except domestic products);

(6) Production date and validity period/production batch number and expiration date. The minimum sales package label of disinfectants should be marked with the following:

(1) Product name;

(2) Product hygiene license approval number;

(3) Production enterprise (name, address);

(4) Hygiene license number of the production enterprise (excluding imported products);

(5) Name of country or region of origin (excluding domestic products) );

(6) Main active ingredients and their content;

(7) Production date and validity period/production batch number and expiration date;

(8) ) Disinfectants used on mucous membranes should also be labeled “for diagnosis and treatment in medical and health institutions only”. Disinfectant instructions should be marked with the following contents:

(1) Product name;

(2) Product hygiene license approval number;

(3) Dosage form and specifications ;

(4) Main active ingredients and their contents;

(5) Categories of killing microorganisms;

(6) Scope of use and methods of use;< /p>

(7) Precautions;

(8) Implementation standards;

(9) Production enterprise (name, address, contact number, postal code);< /p>

(10) Hygiene license number of the production enterprise (excluding imported products);

(11) Name of the country or region of origin (excluding domestic products);

(12) Validity period;

(13) Disinfectants used on mucous membranes should also be marked with the content "Only for diagnosis and treatment in medical and health institutions".

The label of the sterilization equipment package (except the minimum sales package) should be marked with the following content:

(1) Product name and model;

(2) Product hygiene license approval number;

(3) Manufacturing enterprise (name, address);

(4) Hygiene license number of the manufacturing enterprise (excluding imported products);

(5) Country of origin or Region name (except domestic products);

(6) Production date;

(7) Validity period (limited to biological indicators, chemical indicators and sterilization packaging, etc.);< /p>

(8) Transportation and storage conditions;

(9) Precautions. The minimum sales package label or nameplate of sterilizing equipment should be marked with the following:

(1) Product name;

(2) Product hygiene license approval number;

( 3) Manufacturing enterprise (name, address);

(4) Hygiene license number of the manufacturing enterprise (excluding imported products);

(5) Name of country or region of origin (domestic products) (Except products);

(6) Production date;

(7) Validity period (limited to biological indicators, chemical indicators and sterilization packaging);

(8) Precautions. The instructions for disinfection equipment should be marked with the following content:

(1) Product name;

(2) Product hygiene license approval number;

(3) Model specifications;

(4) Main bactericidal factors and their intensity, sterilizing principles and categories of microorganisms to be killed;

(5) Scope of use and methods of use;

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

(7) Precautions;

(8) Implementation standards;

(9) Manufacturing enterprises ( Name, address, contact number, postal code);

(10) Hygiene license number of the production enterprise (except imported products);

(11) Name of the country or region of origin (Except domestic products);

(12) Validity period (limited to biological indicators, chemical indicators and sterilization packaging, etc.). The label of sanitary product packaging (except the smallest sales package) should be marked with the following content:

(1) Product name;

(2) Production company (name, address);

(3) Hygiene license number of the production enterprise (excluding imported products);

(4) Name of the country or region of origin (excluding domestic products);

(5) Storage conditions that comply with product characteristics;

(6) Production date and shelf life/production batch number and expiration date;

(7) Disinfection grade sanitary products should be marked with "disinfection grade" Type, disinfection method, disinfection batch number/disinfection date, expiration date/limited use date. The minimum sales package label of sanitary products should be marked with the following contents:

(1) Product name;

(2) Name of main raw materials;

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

(4) Hygiene license number of the production enterprise (excluding imported products);

(5) Name of the country or region of origin (Except domestic products);

(6) Production date and validity period (shelf life)/production batch number and expiration date;

(7) Disinfection grade products should be marked with "disinfection grade" words;

(8) Sanitary wipes should also be labeled with the active sterilizing ingredients and their content, usage methods, scope of use and precautions. In addition to the content stipulated in Article 13 of this specification, the minimum sales package label of antibacterial (antibacterial) agents should also indicate the active ingredients and their contents of the main raw materials of the product; antibacterial (antibacterial) agents containing plant ingredients should also indicate Label the Latin names of the main plants; if the killing rate of indicator bacteria is greater than or equal to 90%, it can be labeled "has bactericidal effect"; if the inhibitory rate of indicator bacteria reaches 50% or the diameter of the inhibitory ring is greater than 7 mm, it can be labeled " "Has antibacterial effect"; if the antibacterial rate is greater than or equal to 90%, it can be labeled "has strong antibacterial effect".

Anti-bacterial products used on the vaginal mucosa should be labeled “not for use in the prevention of sexually transmitted diseases during sexual life”.

The instructions for anti-bacterial agents should be marked with the following content:

(1) Product name;

(2) Specifications and dosage forms;

(3) The main active ingredients and their contents. Antibacterial (anti)bacterial agents of plant ingredients should be labeled with the Latin names of the main plants;

(4) Types of microorganisms inhibited or killed;

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

(6) Health license number of the production enterprise (excluding imported products);

(7) Country of origin or Region name (except domestic products);

(8) Scope of use and method of use;

(9) Precautions;

(10) Implementation standards;

(11) Production date and shelf life/production batch number and expiration date. The instructions for contact lens care products should be marked with the following content:

(1) Product name;

(2) Specifications and dosage forms;

(3) Manufacturing company (name, address, contact number, postal code);

(4) Hygiene license number of the production enterprise (excluding imported products);

(5) Name of the country or region of origin (Except domestic products);

(6) Scope of use and method of use;

(7) Precautions;

(8) Implementation standards;

p>

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

Contact lens care products with disinfecting effect should also indicate the main active ingredients and content, and the type of microorganisms killed. The following contents are prohibited on the labels and instructions of disinfection products:

(1) Products such as sanitary napkins (paper) are prohibited from labeling disinfection, sterilization, sterilization, sterilization, medicine, health care, dehumidification, moisturizing, and anti-itching , anti-inflammatory, anti-inflammatory, spermicidal, contraceptive, and anti-bacterial effects without testing evidence;

(2) Sanitary wipes, wet wipes and other products are prohibited from labeling disinfection, sterilization, Contents such as sterilization, medicine, high efficiency, non-toxic, prevention of sexually transmitted diseases, treatment of diseases, reduction or relief of disease symptoms, anti-inflammatory, anti-inflammatory, use objects and shelf life without inspection basis. Sanitary wipes should also be prohibited from labeling antimicrobial/microbicidal categories without inspection evidence and antibacterial (antibacterial) effects without inspection evidence. Wet wipes should also be prohibited from being labeled with anti/antibacterial and bactericidal effects;

(3) Anti-bacterial (anti)bacterial agent products are prohibited from being labeled with high efficiency, non-toxic, disinfection, sterilization, sterilization, anti-inflammation and anti-inflammation , treatment of diseases, alleviation or relief of disease symptoms, prevention of sexually transmitted diseases, spermicide, contraception, and content of prohibited ingredients such as antibiotics and hormones; it is prohibited to label dosages and objects without testing basis, antimicrobial/microbicidal categories without testing basis, no The validity period of the test basis and the anti-bacterial (anti-bacterial) effect without test basis; it is prohibited to label it for use in specific parts of the human body such as feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anus and intestines; anti-bacterial products are prohibited Labeling applies to damaged skin, mucous membranes, wounds, etc.;

(4) It is prohibited to label contact lens care products with words such as full function, high efficiency, non-toxic, sterilization or sterilization, etc., and it is prohibited to label words without inspection basis. Disinfection, anti-(bacterial) effects, as well as dosage and shelf life without testing basis;

(5) Disinfectants are prohibited from being labeled as broad-spectrum, fast-acting, non-toxic, anti-inflammatory, anti-inflammatory, disease treatment, alleviation Or alleviating disease symptoms, preventing sexually transmitted diseases, spermicide, contraception, and prohibited ingredients such as antibiotics and hormones; it is prohibited to label the scope of use, dosage and method without testing basis, and the category and validity period of killing microorganisms without testing basis; it is prohibited to label the use for Specific parts of the human body such as feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anus and intestines, etc.;

(6) It is prohibited to indicate invalid approval numbers on the labels and instructions for use of disinfection products or license number as well as disease symptoms and disease name (except when the disease name is part of the name of the microorganism, such as "poliovirus", etc.). The meanings of the following terms in this specification:

Disinfection products: including disinfectants, disinfection equipment (including biological indicators, chemical indicators and packaging materials for sterilization items) and sanitary products.

Label: refers to all labels on the product’s minimum sales package and other packaging.

Instructions: refers to all relevant text, audio, video, graphics and other information included in the product sales package.

Sterilization: The process of killing or removing all microorganisms on the transmission medium.

Disinfection: Kill or remove pathogenic microorganisms on the transmission medium to render them harmless.

Antibacterial: The process of using chemical or physical methods to kill bacteria or hinder the growth, reproduction and activity of bacteria.

Bacteriostasis: the process of using chemical or physical methods to inhibit or hinder the growth, reproduction and activity of bacteria.

Contact lens care products: refers to products specifically used for contact lens care, with the functions of cleaning, sterilizing, rinsing or preserving lenses, neutralizing detergents or disinfectants, and physically relieving (or lubricating) eye problems caused by contact lenses. Solutions for treating facial discomfort and other functions, or soluble solid preparations that can be formulated into solutions for use.

Hygienic wipes: specifically refers to wet wipes with sterilizing effect that comply with the "Hygienic Standards for Disposable Hygienic Products" (GB15979). The killing rate for Escherichia coli and Staphylococcus aureus is ≥90%. If it is labeled as having an effect on fungi, the killing rate for Candida albicans should be ≥90%. Its bactericidal effect should be maintained at room temperature for at least 1 year.

Disinfection-level sanitary products: sanitary products that have been treated with effective disinfection methods such as ethylene oxide, ionizing radiation or pressure steam and meet the disinfection-level requirements specified in the "Hygienic Standards for Disposable Hygienic Products" (GB15979) .

Product liability unit: refers to a legal entity that legally bears liability for personal injury or property damage to others due to product defects. When entrusting production and processing, it refers specifically to the entrusting party. This specification will come into effect on May 1, 2006. The Ministry of Health is responsible for interpretation.

Attachment: Requirements for writing various contents of disinfection product labels and instructions (omitted)