Definition of disinfection products

According to Article 78 of the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases, disinfection refers to the use of chemical, physical and biological methods to kill or eliminate pathogenic microorganisms in the environment.

In terms of the purpose, this kind of products is used for disease prevention, but not for disease treatment or diagnosis; in terms of mechanism, it can eliminate pathogenic microorganisms by chemical, physical and biological methods, rather than pharmacological or immunological methods; in terms of the object of action, it mainly focused on pathogenic microorganisms in the environment rather than diseases.

According to Article 46 of the Measures for the Administration of Disinfection, disinfection products include disinfectants, disinfection equipment (including biological indicators, chemical indicators and packaging of sterilized items), sanitary products and disposable medical supplies.

Disinfectant (Antibacterial/Bacteriostatic) testing items and standards

Product Category	Testing items		Testing standard
Disinfectant	Exterior		1."Disinfection Technical Specifications 2002 Edition" 2.Corresponding national standards for various disinfectants 3.Enterprise standards for the record of each enterprise
	Determination of active ingredient content
	PH measurement
	Stability test
	Continuous use stability test
	Determination of lead, arsenic and mercury
	Metal Corrosion Test
	Determination of the killing effect of microorganisms in the laboratory (Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, Pseudomonas aeruginosa, Staphylococcus albicans, Aspergillus niger, M. virus, influenza virus, HIV, hand, foot and mouth virus, etc.)
	Simulate field trials or field trials (hard surfaces, hands, skin, air, medical devices, endoscopes, fabrics, food and drink utensils, etc.)
	Toxicological safety testing (acute oral toxicity test, acute inhalation toxicity test, one intact skin irritation test, multiple intact skin irritation test, eye irritation test, vaginal mucosal irritation test, one mutagenicity test, etc.)
	Overall performance test
Antibacterial (bacteriostatic) agents /sanitary products	Determination of active ingredient content		1."Disinfection Technical Specifications 2002 Edition" 2.Hygiene Standard for Disposable Sanitary Products GB 15979-2002 3.Enterprise standards for the record of each enterprise
	Stability test
	PH measurement
	Microbial indicators	The total number of bacterial colonies
		Coliform bacteria
		Total number of fungal colonies
		Pathogenic pyogenic bacteria
	Kill (inhibit) microbial indicators	E. coli kill (inhibition) test
		Staphylococcus aureus kill (inhibition) test
		Candida albicans kill (inhibition) test
		Other microbial killing (inhibition) tests
	Toxicological index detection	One complete skin irritation test, multiple complete skin irritation tests, eye irritation test, vaginal mucosal irritation test, acute oral toxicity test, etc.

Corresponding national standards for various disinfectants

Types of disinfection products	Sanitation standard name and number
Chlorine dioxide disinfectant	Hygienic standard for chlorine dioxide disinfectant GB 26366-2010
Guanidine disinfectants	Hygienic standard for guanidine disinfectants GB 26367-2020
Iodine-containing disinfectant	Hygienic standard for iodine-containing disinfectants GB 26368-2020
Quaternary ammonium salt disinfectant	Hygienic standard for quaternary ammonium salt disinfectants GB 26369-2020
Bromine-containing disinfectants	Hygienic standard for bromine-containing disinfectants GB 26370-2020
Peroxide-based disinfectants	Hygienic standard for peroxide-based disinfectants GB 26371-2020
Glutaraldehyde Disinfectant	Hygienic standard for glutaraldehyde disinfectant GB 26372-2020
Ethanol disinfectant	Hygienic standard for ethanol disinfectant GB 26373-2020
Phenolic disinfectants	Hygienic requirements for phenolic disinfectants GB 27947-2020
Air sanitizer	Hygienic requirements for air disinfectants GB 27948-2020
Hand sanitizer	Hand Sanitizer Hygiene Requirements GB 27950-2020
Skin disinfectant	Hygiene requirements for skin disinfectants GB 27951-2011
Disinfection of common surfaces	Sanitary requirements for surface disinfectants of ordinary objects GB 27952-2020
Foci disinfectant	Sanitary requirements for disinfectants in foci GB 27953-2020
Mucous membrane disinfectant	General requirements for mucosal disinfectants GB 27954-2020
Medical device disinfectant	Sanitary requirements for disinfectants for medical devices GB/T 27949-2020

Classification and management of disinfection products

China implements classified management of disinfection products according to the use and the risk level of the object of use. Product responsible units shall conduct sanitation and safety evaluations by themselves or by entrusting a third party before the Category 1 and Category 2 disinfection products are put on the market for the first time, and shall be responsible for the evaluation results. Disinfection products that have passed the health and safety evaluation can be marketed.

Category 1:High risk, requiring strict management to ensure safety and effectiveness. This kind of disinfection products covers high-level disinfectants and disinfection devices for medical devices, sterilants and sterilization devices, skin and mucous membrane disinfectants, biological Indicator, chemical indicator of sterilization effect.

Category 2:Moderate risk, management needs to be strengthened to ensure safety and effectiveness. This kind of disinfection products covers disinfectants, disinfection equipment, chemical indicators, and sterilized items other than Category 1 products, packaging with sterilization labels, antibacterial (bacteriostatic) preparations.

Category 3:Low risk, and routine management can ensure safety and effectiveness. This kind of disinfection products covers sanitary products other than antibacterial (bacteriostatic) preparations.

Note: When the same disinfection product involves different categories, it should be managed by its highest risk category.

Legal basis for filing

• Administrative Measures for Disinfection
• Regulations on Sanitary Safety Evaluation of Disinfection Products
• Regulations on the Administration of Sanitation Administrative Licensing for New Disinfection Products and New Water-related Products

Specific information requirements

Disinfection product filing materials are generally the filing registration form of the disinfection product safety evaluation report, the disinfection product sanitation and safety evaluation report, labels, instructions, test reports and other basic materials. It is necessary to have documents and other materials that allow the production and sales of imported products in the country (region).

CIRSis not involved in the registration of new disinfection products.

Competent authority: provincial (city, district) health and family planning committees

Filing flow chart

C&K Testing can provide testing services for the majority of disinfection product companies. If you have any needs or questions, please contact us attest@cirs-group.com.

China Disinfectant Notification Testing