This specification shall be implemented on May 1, 2006. If the normative documents issued in the past are inconsistent with this specification, this specification shall prevail.

Article 1 In order to strengthen the supervision and management of labels and instructions of disinfection products, this specification is formulated in accordance with the relevant provisions of the Law of the Peoples Republic of China on the Prevention and Control of Infectious Diseases and the Measures for the Administration of Disinfection.

Article 2 This specification applies to the labels and instructions of imported and domestic disinfection products produced, operated or used in China.

Article 3 The relevant contents marked on the labels and instructions of disinfection products shall be true, and there shall be no false, exaggerated, explicit or implied contents of the therapeutic effect and effect on diseases, and meet the following requirements:

• Chinese logos shall be used, and if there are foreign logos, the display contents must comply with the provisions of relevant national laws and standards.
• The product name shall comply with the Regulations of the Ministry of Health on the Naming of Health-related Products, and shall include the brand name (or brand name), generic name, and attribute name; For disinfection products that have a variety of disinfection or anti-bacteriostatic uses or contain a variety of effective bactericidal ingredients, only the brand name (or brand name) and attribute name can be marked when naming.
• The name, dosage form, model, approval number, content of active ingredients, scope of use, method of use, validity period/service life, etc. of disinfectants and disinfection devices should be consistent with the health license or filing of the health administrative department at or above the provincial level; Hygiene products are mainly effective. The content of ingredients shall conform to the range specified in the product implementation standard.
• The implementation standards of product labeling shall comply with national standards, industry standards, local standards and relevant norms. Enterprise standards marked by domestic products should be filed according to law.
• The category of killing microorganisms should be expressed in accordance with the relevant provisions of the “Technical Specifications for Disinfection” of the Ministry of Health; The microbial killing categories of disinfection products approved by the Ministry of Health shall be consistent with those approved by the Ministry of Health in the health license; The microbial killing category of disinfection products that have not been approved by the Ministry of Health shall 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.
• If disinfection products have special requirements for the safety of storage and transportation conditions, they should be clearly indicated in the product identification.
• When marking the information of the production enterprise, the information of the product responsible unit and the actual production and processing enterprise of the product should be marked at the same time (when the two are the same, there is no need to mark them repeatedly).
• The marked production enterprise health license number shall be the actual production enterprise health license number.

Article 4 Products not included in the classification catalogue of disinfection products shall not be marked with any health license certificate number related to the management of disinfection products.

Article 5 The minimum sales packaging of disinfection products shall be printed or labeled. The signature should be clear, firm and cannot be altered. Disinfectants, disinfection equipment, antibacteriostatic agents and contact lens care products should be attached with instructions. If the product label already includes the instructions, no additional instructions may be attached.

Article 6 The label of disinfectant packaging (except the minimum sales packaging) shall be marked with the following contents:

• Product name;
• Product hygiene license approval number;
• Manufacturing enterprise (name and address);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);

Manufacturing date and expiration date/production batch number and expiration date.

Article 7 The minimum sales packaging label of disinfectants shall be marked with the following contents:

• Product name;
• Product hygiene license approval number;
• Manufacturing enterprise (name and address);
• The health license number of the production enterprise (except for imported products); (5) The name of the country or region of origin (except domestic products);
• Main active ingredients and their contents;
• Production date and expiration date/production batch number and expiration date;
• Disinfectants used for mucous membranes should also be marked with “only for medical and health therapeutic”.

Article 8 The disinfectant instructions shall be marked with the following contents:

• Product name;
• Product hygiene license approval number;
• Dosage form and specification;
• The main active ingredients and their contents;
• Categories of killing microorganisms;
• Scope and method of use;
• Matters needing attention;
• Implementing standards;
• Production enterprise (name, address, contact telephone number, postal code);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);
• Validity period; (thirteen) disinfectants used in mucosa should also be marked with the content of “only for diagnosis and treatment in medical and health institutions”.

Article 9 The label of disinfection equipment packaging (except the minimum sales packaging) shall be marked with the following contents:

• Product name and model;
• Product hygiene license approval number;
• Manufacturing enterprise (name and address);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);
• Production date;
• Validity period (limited to biological indicators, chemical indicators and sterilized packaging, etc.);
• Transportation and storage conditions;
• Matters needing attention.

Article 10 The minimum sales packaging label or nameplate of disinfection equipment shall be marked with the following contents:

• Product name;
• Product hygiene license approval number;
• Manufacturing enterprise (name and address);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);
• Production date;
• Validity period (limited to biological indicators, chemical indicators and sterilized packaging);
• Matters needing attention.

Article 11 The instructions for disinfection devices shall be marked with the following contents:

• Product name;
• Product hygiene license approval number;
• Model specifications;
• Main bactericidal factors and their strength, bactericidal principles and types of bactericidal microorganisms;
• Scope and method of use;
• Service life (or life of main components);
• Matters needing attention;
• Implementing standards;
• Production enterprise (name, address, contact telephone number, postal code);
• the health license number of the production enterprise (except for imported products); (11) Country or region of originName (except domestic products);
• Validity period (limited to biological indicators, chemical indicators and sterilized packaging, etc.).

Article 12 The labels of sanitary products packaging (except the minimum sales packaging) shall be marked with the following contents:

• Product name;
• The production enterprise (name and address);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);
• Storage conditions that comply with product characteristics;
• Production date and shelf life/production batch number and expiration date;
• Sanitary products of disinfection grade should be marked with the words “disinfection grade”, disinfection method, disinfection batch number/disinfection date, expiration date/limited use date.

Article 13 The minimum sales packaging label of sanitary products shall be marked with the following contents:

• Product name;
• Names of main raw materials;
• Manufacturing enterprise (name, address, contact telephone number, postal code);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);
• Production date and expiration date (shelf life)/production batch number and expiration date;
• 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.

Article 14 The minimum sales packaging label of anti-bacteriostatic agents shall not only mark the contents specified in Article 13 of this specification, but also mark the active ingredients and contents of the main raw materials of the product; Anti-bacteriostatic agents containing plant ingredients should also be marked with the Latin names of the main plants; If the killing rate of indicator bacteria is greater than or equal to 90%, it can be marked as “bactericidal”; If the bacteriostatic rate of the indicator bacteria reaches 50% or the diameter of the bacteriostatic ring is greater than 7mm, it can be marked as “Anti-bacteriostatic effect”; If the bacteriostatic rate is greater than or equal to 90%, it can be marked as “having strong bacteriostatic effect”. Anti-bacterial products used in pudendal mucosa should be marked “not to be used for the prevention of sexually transmitted diseases in sexual life”.

Article 15 The instructions for antibacteriostatic agents shall be marked with the following contents:

• Product name;
• Specifications and dosage forms;
• The main active ingredients and contents, and the anti-bacteriostatic agents of plant ingredients should be marked with the Latin names of the main plants;
• Categories of inhibiting or killing microorganisms;
• Production enterprise (name, address, contact telephone number, postal code);
• Hygiene license of production enterprise Certificate number (except imported products);
• The name of the country or region of origin (except domestic products);
• The scope and method of use;
• Matters needing attention;
• Implementation standards;
• Production date and shelf life/production batch number and expiration date.

Article 16 The instructions of contact lens care products shall be marked with the following contents:

• Product name;
• Specifications and dosage forms;
• Manufacturing enterprise (name, address, contact telephone number, postal code);
• The health license number of the production enterprise (except for imported products);
• The name of the country or region of origin (except domestic products);
• Scope and method of use;
• Matters needing attention;
• Implementing standards;
• Production date and shelf life/production batch number and expiration date. Contact lens care products with disinfection effect should also indicate the main active ingredients and contents, and the category of killing microorganisms.

Article 17 It is forbidden to use two or more product names on the labels and instructions of the same disinfection product. The name of sanitary wipes and wipes shall not use the word anti-bacteriostatic.

Article 18 The labels and instructions of disinfection products are prohibited from marking the following contents:

• Sanitary napkins (paper) and other products are forbidden to be labeled with disinfection, sterilization, drugs, health care, dehumidification, moisturizing, antipruritic, anti-inflammatory, spermicidal, contraceptive, and antibacterial effects without test basis;
• Sanitary wet wipes, wet wipes and other products are forbidden to be labeled with disinfection, sterilization, medicine, high efficiency, non-toxicity, preventing sexually transmitted diseases, treating diseases, alleviating or alleviating disease symptoms, anti-inflammatory, usage objects and shelf life without inspection basis, etc. Sanitary wipes should also be prohibited from labeling the antimicrobial category without inspection basis and the anti-bacteriostatic effect without inspection basis. Wet wipes should also be prohibited from labeling anti-bacteriostatic and bactericidal effects;
• Anti-bacteriostatic products are prohibited from being labeled with high efficiency, non-toxic, disinfection, sterilization, anti-inflammatory, treatment of diseases, alleviation or relief of disease symptoms, prevention of sexually transmitted diseases, spermicide, contraception, and antibiotics, hormones and other prohibited ingredients; It is forbidden to mark the dose and object without inspection basis, the antimicrobial category without inspection basis, the validity period without inspection basis and the anti-bacteriostatic effect without inspection basis. It is forbidden to mark specific parts such as human feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectal, etc. Antibacterial products are prohibited from labeling to be used for damaged skin, mucous membranes, wounds, etc.;
• Contact lens care products are forbidden to be labeled with the words full function, high efficiency, non-toxicity, sterilization, disinfection and anti-bacteriostatic effects without inspection basis, as well as the dosage and shelf life without inspection basis;
• Disinfectants are prohibited from labeling broad-spectrum, quick-acting, non-toxic, anti-inflammatory, treating diseases, alleviating disease symptoms, preventing sexually transmitted diseases, killing spermicides, contraception, antibiotics, hormones and other prohibited ingredients;
• 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 specific parts such as human feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectal, etc.;
• The labels and instructions for use of disinfection products are prohibited from marking invalid approval numbers or license numbers, disease symptoms and disease names (except when the disease names are part of the microorganism names, such as “poliovirus”, etc.).

Article 19 The contents marked in labels and instructions shall comply with the provisions of the Annex “Requirements for Writing Contents of Disinfection Product Labels and Instructions” of this specification.

Article 20 The meanings of the following terms in this specification:

Disinfection products: including disinfectants, disinfection equipment (including biological indicators, chemical indicators and packaging of sterilized articles) and sanitary products.

Label: refers to all identification on the smallest sales package and other packaging of the product. Instruction manual: refers to all relevant words, audio and video, patterns and other materials attached to the product sales package.

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

Disinfection: Killing or removing pathogenic microorganisms on the transmission vector to achieve harmless treatment.

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 inhibiting or hindering the growth, reproduction and activity of bacteria by chemical or physical methods.

Contact lens care products: refer to solutions specially used for contact lens care, which have the functions of cleaning, sterilizing, rinsing or preserving lenses, neutralizing detergents or disinfectants, physically relieving (or lubricating) eye discomfort caused by contact lenses, etc., or soluble solid preparations that can be formulated into solutions.

Sanitary wipes: specifically refer to wet wipes with sterilizing effect that meet the Hygienic Standard for Disposable Sanitary Products (GB15979). The killing rate of Escherichia coli and Staphylococcus aureus is ≥ 90% if the bacteria are effective; the killing rate of Candida albicans should be ≥ 90% If the bacteria are effective, and its bactericidal effect should be maintained at room temperature for at least 1 year.

Disinfection grade sanitary products: sanitary products that have been treated by effective disinfection methods such as ethylene oxide, ionizing radiation or pressure vapor and meet the disinfection grade requirements specified in the Hygienic Standard for Disposable Sanitary Products (GB15979).

Product responsibility unit: refers to the legal entity that is liable for compensation for personal injury or property loss caused by product defects according to law. When entrusting production and processing, it specifically refers to the entrusting party.

Article 21 These specifications shall come into force on May 1, 2006. The Ministry of Health is responsible for the interpretation.

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