WS/T 628-2018Technical requirements for the hygiene and safety evaluation of disinfectant products (English PDF)

5.1 Label (nameplate), instructions

It should meet the requirements of the relevant specifications and standards for the labeling instructions for disinfection products.

5.2 Inspection report

5.2.1 The inspection report of two testing institutions shall be provided without the inspection method of measurement certification.

5.2.2 All inspection items should be completed using the same batch of products, and different batches can be used for the supplementary inspection items, and the effective measurement can be re-measured.

The content of the product, the pH value, and the product whose active ingredient is not purely chemical component should be re-measured to kill a microorganism with the strongest resistance (or Test) and pH.

5.2.3 Prior to the initial listing of the disinfection products, the inspection items shall comply with Appendix B, Appendix C, Appendix D, Appendix E, and Appendix according to different categories of products.

F. Requirements of Appendix G.

5.2.4 The re-inspection of disinfection products after listing is as follows.

- In case of 4.6 a), the disinfectant and anti-bacteria preparations should be tested for active ingredient content, stock solution stability test and pH value.

The disinfection equipment shall be tested for the strength of the main bactericidal factors. If the conditions for determining the bactericidal factors are not met, the simulated field test shall be carried out;

The biological indicator shall be tested for the amount of bacteria, the chemical indicator shall be determined for the color change, and the sterilization with the sterilization mark the packaging of the product should be tested for the penetration of the sterilization factor.

- In case of 4.6 b), the disinfectant and anti-bacteria preparations should have the active ingredient content, pH value, and the strongest resistance.

Biological killing (or inhibition) test and stability test; stability test should be performed using the original test sample. Biological indicator the test indicator and PCD shall be tested for stability; the package of sterilized articles with the sterilization mark shall be tested for the validity of the packaging materials.

Test.

- In the case of 4.6 c), the corresponding physical and chemical, microbial killing (or inhibition) and toxicological tests should be carried out.

- In the case of 4.6 d), the disinfectant should be tested for active ingredient content, pH value and one of the most resistant microbial killing tests.

The poisonous device should be tested for the strength of the main bactericidal factor and one of the most resistant microorganisms. The biological indicator should be bacteriostatic.

Determination, sterilization effect Chemical indicators should be measured for color changes.

5.2.5 The test results shall comply with the requirements of relevant standards and specifications.

5.2.6 See Appendix H for the format of the inspection report.

5.3 Implementation standards

5.3.1 The implementation standards for domestically produced disinfection products are self-declared and open corporate standards in the national enterprise standard information public service platform;

The implementation standards for toxic products are product quality standards.

5.3.2 The implementation standards of disinfectants, indicators and anti-bacteria preparations should include the quality requirements of raw materials (including grade and purity), Technical requirements and inspection methods, type inspection items, factory inspection items, etc., wherein the technical indicators of disinfectant and anti-bacteria preparations include Sensory indicators, physical and chemical indicators, microbial indicators, killing/inhibiting microbial indicators.

5.3.3 The implementation standards for disinfection equipment should include the name and model, raw materials, main components and parameters, and technical requirements (including strong sterilization factors).

Degree, kill microbial indicators) and test methods, type inspection items, factory inspection items, etc.

5.3.4 Sanitary quality requirements for raw materials for disinfectants and anti-bacterial preparations and raw materials, main components and parameters of disinfection equipment shall be in accordance with the hygiene standards and technical specifications of the products should be disinfected.

5.3.5 The technical requirements for disinfection products shall comply with the provisions of national health laws, regulations and standards.

5.4 Production enterprise health permit or documentary proof of production and sales

5.4.1 The sanitary license of the domestic disinfection product production enterprise shall be within the validity period of the license, and the production project and production category shall be related to the evaluated product.

The information of the production address and legal representative (responsible person) shall be consistent with the corresponding contents of the basic situation table in the health safety evaluation report form.

5.4.2 The certification documents for the production and sales of the country (region) where the imported disinfection product is produced shall comply with the laws and regulations of the country of origin (region).

5.5 Disinfectants, indicators and anti-bacterial formulations

It should be consistent with the actual production, and in line with the relevant requirements of the national health administrative department on prohibited substances, the writing format of the formula is shown in the appendix.

5.6 Disinfecting device structure

The main components and parameters should be consistent with the actual production.

Appendix A

(normative appendix) Disinfection product health safety evaluation report format the format of the hygienic safety evaluation report for disinfection products is shown in Table A.1.

Table A.1 Disinfection product health safety evaluation report format

Disinfection product health safety evaluation report First, the basic situation table Product Responsibility Unit Name Product Responsibility Unit Address Legal representative/responsible person telephone zip code Production company name production enterprise address Actual production unit name actual production unit address Actual production enterprise Health permit number Legal representative/responsible person Import product declaration number Product Category the first sort( ) Second class ( ) Whether the product name complies with the Health Named Product Naming Regulations and the disinfection product labeling instructions Book requirements for specifications and standards Yes ( ) No ( ) Whether the label (nameplate) and the specification comply with the relevant specifications of the labeling instructions for the disinfection product and Standard requirements Yes ( ) No ( ) is the inspection item complete ( ) no ( ) Whether the test result meets the requirements is ( ) no ( ) Whether the product enterprise standard (quality standard) meets the requirements is ( ) no ( ) Whether the category of the product matches the category of the corporate health permit is ( ) no ( ) Whether the product formula has been added to the prohibited raw materials is ( ) No ( ) Whether the product formula is consistent with the actual production product formula ( ) No ( ) Whether the structure diagram of the disinfection device is consistent with the actual structure of the product ( ) No ( ) Whether the raw materials used are qualified ( ) No ( ) Whether the amount of raw materials used meets the relevant regulations is ( ) no ( ) Evaluation conclusion. Whether the disinfection products meet the relevant regulations, norms, and standards are () no ( ) Commitment. The unit is responsible for the conclusion of the sanitation safety evaluation of the disinfection product, and guarantees the label (nameplate) and description provided.

Book, inspection report (including conclusion), enterprise standard or quality standard, product formula, disinfection device structure diagram real, Effective, in line with the products produced and sold, and bear the corresponding legal responsibilities.

Second, the evaluation data (1) label (nameplate), manual;

(2) Inspection report (including conclusions);

(3) Enterprise standards or quality standards;

(4) Proof of production permit for the production license of the domestic product manufacturing enterprise or the country (region) where the imported product is produced and customs declaration form;

(5) product formula;

(6) Structure diagram of disinfection equipment (main components and parameters).

Note 1. When operating or using the unit, the information on the health safety assessment report provided by the product responsible unit includes the label (nameplate), instructions, the conclusion of the inspection report, the health permit of the domestic product manufacturer, and the documents permitting the production and sales of the country (region) where the imported product is produced and Customs declaration.

Note 2. (1), (3), (4) are originals or copies, and (2), (5) and (6) are originals. Copies should be blamed by the product the unit is stamped with the official seal.

Note 3. This watch should be printed on A4 size paper. The data should be arranged in order, and the official seal of the product responsible unit should be stamped page by page and bound into a book.

Appendix B

(normative appendix) Disinfectant inspection project the disinfectant inspection items are shown in Table B.1.

Table B.1 Disinfectant Inspection Project

Test items

Disinfecting object

The first type of disinfection products, the second type of disinfection products Medical equipment and supplies Skin and mucous membrane Medical equipment and supplies life drink Swim Pool water hospital Sewage Hard object surface Fabric and its He porous Body surface Drinking food processing Tools and equipment Melon vegetables indoor air Object c Bacteria a High level disinfection Mirror b Medium level disinfection Low level disinfection Determination of active ingredient content d Stability test pH determination Determination of lead, arsenic and mercury Metal corrosion test f ± ± ± ± ± ± Determination of microbial contamination indicators Test items Disinfecting object the first type of disinfection products, the second type of disinfection products Medical equipment and supplies Skin and mucous membrane Medical equipment and supplies life drink Swim Pool water hospital Sewage Hard object surface Fabric and its He porous Body surface Drinking food processing Tools and equipment Melon vegetables indoor air Object c Bacteria a High level disinfection Mirror b Medium level disinfection Low level disinfection Staphylococcus aureus killing test (including neutralizer identification test g) E. coli killing test (including neutralizer identification test) Pseudomonas aeruginosa killing test (including neutralizer identification test) ± ±h Candida albicans killing test i (including neutralizer identification test) ± ± ± Aspergillus killing test (including neutralizer identification) ± ± Mycobacterium tuberculosis killing test (including neutralizer identification test) Poliovirus inactivation test (including neutralizer identification test) Test items Disinfecting object the first type of disinfection products, the second type of disinfection products Medical equipment and supplies Skin and mucous membrane Medical equipment and supplies life drink Swim Pool water hospital Sewage Hard object surface Fabric and its He porous Body surface Drinking food processing Tools and equipment Melon vegetables indoor air Object c Bacteria a High level disinfection Mirror b Medium level disinfection Low level disinfection Bacillus subtilis black var.

Extinction test (including neutralizer identification test) Test) Continuous use stability test k ± ± ± Simulated field test * * * * * * Field Test Overall performance test n Acute oral toxicity test Acute inhalation toxicity test skin stimulate Test o One broken skin Stimulation test One complete skin Stimulation test + ± Multiple intact skin Stimulation test Eye irritation test Test items Disinfecting object the first type of disinfection products, the second type of disinfection products Medical equipment and supplies Skin and mucous membrane Medical equipment and supplies life drink Swim Pool water hospital Sewage Hard object surface Fabric and its He porous Body surface Drinking food processing Tools and equipment Melon vegetables indoor air Object c Bacteria a High level disinfection Mirror b Medium level disinfection Low level disinfection Vaginal mucosal stimulation test ±p a mutagenic test q

Note 1. The labeling instructions are marked with other disinfecting objects or disinfectants that have a killing effect on other microorganisms. The inspection items shall be determined according to the disinfection objects and the categories of microbicides to be labeled according to the label instructions; if no toxicity is indicated, the corresponding instructions shall be made accordingly. Toxic test Test.

Note 2. "+" is a mandatory item; "space" is not a project; "*" is an optional item; "±" is an optional project.

The disinfectant used in the sterilizer is only used for content, pH and stability, and ethylene oxide may not be used.

Endoscopes for invasive treatment, endoscopes or labeling instructions for contact with damaged skin mucosa marked for endoscopic sterilization should be tested according to the inspection items of the sterilized medical device. Endoscopic disinfection tests are divided into simulated field tests and laboratory tests. Simulation site in the test, if the label specification is marked with high level disinfection of the endoscope, the quantitative bactericidal test of Bacillus subtilis var. niger spores should be carried out; if not labeled, a bactericidal test of Mycobacterium marinum plus a bacterial propagule should be carried out. Laboratory test, where the label specification is marked for high-level endoscopic disinfection, Bacillus subtilis var. niger spores should be tested for quantitative bactericidal test; unmarked, it should be carried out for Mycobacterium marinum, Candida albicans, poliovirus, Staphylococcus aureus, Escherichia coli and P. aeruginosa Quantitative sterilization test.

Contamination. Excreta, secretions, blood and its contaminated items and environment.

Limited to pure chemical components.

Drinking utensils, fruits and vegetables, drinking water, food processing tools and equipment are only used for lead and arsenic.

The labeling instructions are not marked with disinfectants that should not be used for the disinfection of metal objects. Metal corrosion tests should be carried out.

When performing the bactericidal test of Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa at the same time, only one of the bacteria is selected for the neutralizing agent identification test.

Label labeling is used for disinfection of common bacteria in hospital infections, and should be done for quantitative bactericidal test of Pseudomonas aeruginosa.

Label labeling instructions for the surface disinfection of sanitary ware should be done on the Candida albicans quantitative sterilization test.

The labeling instructions labeling disinfectants that have a killing effect on fungi should be subjected to a quantitative sterilization test of Aspergillus niger.

The disinfectant for continuous use of the labeling instructions shall be subjected to a continuous use stability test.

Test items

Disinfecting object

The first type of disinfection products, the second type of disinfection products Medical equipment and supplies Skin and mucous membrane Medical equipment and supplies life drink Swim Pool water hospital Sewage Hard object surface Fabric and its He porous Body surface Drinking food processing Tools and equipment Melon vegetables indoor air Object c Bacteria a High level disinfection Mirror b Medium level disinfection Low level disinfection the simulated field test and field test of the mucosa can be replaced by skin simulation field test and field test.

Simulated field and field test methods for food processing tools and equipment are similar to hard object surfaces.

Drinking water is based on the 2005 edition of the Code for Hygienic Safety Evaluation of Disinfectants and Disinfecting Equipment for Drinking Water (Trial).

A complete skin irritation test should be performed when the disinfectant is in contact with the skin during use; repeated skin irritation tests should be performed repeatedly; repeated skin damage test should be done for broken skin disinfection; skin disinfectant should be done in contact with wounds. Eye irritation test.

The labeling instructions for the disinfectant for vaginal mucosa should be tested for vaginal mucosal irritation.

q Choose one of the gene mutation test or the chromosome aberration test.

Appendix C

(normative appendix) Ethanol, glutaraldehyde, sodium hypochlorite, bleaching powder and bleaching powder disinfectant testing project the test items for ethanol, glutarald...