Disinfection Product Testing
Disinfection Product Testing

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



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).

CIRS is 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 at test@cirs-group.com.

China Disinfectant Notification Testing


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