"Technical Specification for Disinfection" (2002 Edition) is the most comprehensive and authoritative reference material for disinfection experiments in my country. It has played an important role in controlling nosocomial infections. However, with the development of disinfection technology, new disinfection products and methods continue to emerge. The existing evaluation methods cannot verify the effectiveness and safety of disinfection methods. The disinfection evaluation system urgently needs to be updated and improved.

       In 2018, WS628-2018 "Technical Requirements for Sanitary and Safety Evaluation of Disinfection Products" was released. This standard specifies the hygiene and safety evaluation requirements and related inspection items for Class I and Class II disinfection products, but some items do not have specific testing methods and evaluation indicators. , "Disinfection Technical Specifications" (2002 edition) disinfection product inspection technology can no longer meet the existing disinfection technology, therefore, it is urgent to formulate systematic and perfect standards for disinfection and disinfection product inspection methods.

This standard is a method standard formulated for the first time. The main contents include the basic requirements for the inspection of disinfection products, the inspection and evaluation methods of disinfection effects of disinfection products, physical and chemical inspection techniques, and toxicological experimental techniques. It is suitable for evaluating the safety and quality of disinfection products. Effectiveness testing work.

       The formulation of this standard not only improves the disinfection standard system, but also ensures the quality of disinfection products, and plays an important role in controlling disease outbreaks, hospital infection control, handling public health emergencies, and household sanitation and disinfection.

       This standard is based on the "Technical Guidelines for the Inspection of Disinfection Products" (Draft for Comment), combined with the current disinfection standards, to determine the standard framework and content.

One Basic requirements for inspection of disinfection products

      This section presents the basic requirements for disinfection product testing from the perspectives of human, machine, material, method and environment, including laboratory requirements, personnel requirements, disinfection effect inspection requirements, physical and chemical inspection requirements, toxicology evaluation requirements, Result records and reporting requirements, etc. For related content, please refer to GB/T38502-2020 "Laboratory Bactericidal Effect Test Method for Disinfectants", GB/T38496-2020 "Disinfectant Safety Toxicological Evaluation Procedures and Methods" and "Disinfection Technical Specifications" ( 2002 edition).

Two Inspection and evaluation method of disinfection effect

        The content of this section is the inspection and evaluation of the disinfection effect of disinfection products, including laboratory, simulated field and field tests of disinfection and sterilization effects of disinfectants, air disinfection test, water disinfection test, disinfection (sterilization) equipment identification test, disinfection Sterilization indicator identification test and sterilization medical supplies packaging material identification test, etc.

        The experimental methods of disinfectant laboratory, simulated field and field test, and air disinfection test are based on the "Technical Specification for Disinfection" (2002 Edition), and refer to GB/T38502-2020 "Testing Method for Bactericidal Effect of Disinfectant Laboratory" and GB/T38502-2020. T 38504-2020 "Evaluation Method of Spray Disinfection Effect", WS/T683-2020 "Microbiological Requirements for Disinfection Test", etc. The water disinfection effect evaluation test is compiled on the basis of "Disinfection Technical Specification" (2002), referring to GB18466-2005 "Water Pollutant Discharge Standard for Medical Institutions", "Sanitary Safety Evaluation Specification for Drinking Water Disinfectants and Disinfection Equipment" (trial), etc. made. The identification test of disinfection (sterilization) equipment and the identification test of packaging materials for sterilized medical supplies are based on the "Technical Specification for Disinfection" (2002) and refer to GB 28235-2020 "Sanitary Requirements for Ultraviolet Sterilizers" and GB 28232-2020 "Ozone Disinfection" Sanitary Requirements for Generators, GB 28233-2020 Hygienic Requirements for Sodium Hypochlorite Generators, GB28234-2020 Hygiene Requirements for Acidic Electrolyzed Water Generators, GB 27955-2020 Hygiene Requirements for Hydrogen Peroxide Gas Plasma Low Temperature Sterilizers, GB /T19633-2015 "Terminal Sterilization Medical Device Packaging", "Pharmacopoeia of the People's Republic of China", etc.

       The identification test of disinfection and sterilization indicators refers to relevant domestic and foreign standards, and the biological indicators refer to GB 18281-2015 "Biological Indicators for Sterilization of Healthcare Products" and GB/T33420-2016 "Test Methods for Biological Indicators of Pressure Steam Sterilization" ", GB/T 33417-2016 "Test method for biological indicators of hydrogen peroxide gas sterilization", GB/T33419-2016 "Test method for biological indicators of ethylene oxide sterilization" and ISO 11138 series of standards. The chemical indicators refer to the GB18282-2015 "Healthcare Products Sterilization Chemical Indicators" series of standards, GB/T33418-2016 "Ethylene Oxide Sterilization Chemical Indicators Test Methods" and the ISO11140 series of standards. The relevant content of the test equipment refers to GB/T 24628-2009 "Biological and Chemical Indicator Test Equipment for Sterilization of Healthcare Products", the test content of B-D lumen equipment refers to EN867-5, and the test content of pressure steam sterilization dressings PCD refers to AMMIST 79 and other standards. The test requirements for five types of chemical indicators for sterilization of hydrogen peroxide gas plasma (including hydrogen peroxide gas) are compiled based on GB18282.1 Appendix C and GB/T33417. The consistency evaluation of shortened incubation time refers to the US FDA biological indicator premarket notification 510(k).

Three physical and chemical inspection technology

The content of this section is divided into nine parts, including the determination of raw materials or single preparations of disinfection products, determination of active ingredients in compound disinfectants, determination of pH value, oxidation-reduction potential (ORP), lead, mercury, and arsenic, and the stability of disinfectants. Determination and testing of metal corrosion, etc. It is compiled on the basis of "Technical Specifications for Disinfection" (2002 edition) and combined with the updated active ingredient determination methods in various disinfectant standards. The test methods for disinfectant stability and metal corrosivity are consistent with GB/T38498-2020 "Evaluation Method of Disinfectant Metal Corrosion" and GB/T 38499-2020 "Disinfectant Stability Evaluation Method".

Four  Toxicology experimental technology

       This section contains the acute oral toxicity test and acute inhalation toxicity test, skin irritation test, acute eye irritation test, vaginal mucosa stimulation test, skin allergy test, subacute toxicity test and mutagenic test, through the mouth and the chronic toxicity test, consultations for test, such as chronic toxicity test, carcinogenic test 12 toxicological experiments, This part is consistent with GBT38496-2020 Procedures and Methods for Toxicological Evaluation of Disinfectant Safety.

Attachment: The full text of "Disinfection Product Detection Method" can be downloaded by scanning the two-dimensional code

The drafting group of "Testing Methods for Disinfection Products"

April 9, 2021