Test requirements of existing disinfection product (Biocides) in China

Background

In accordance with Regulations on the Safety Evaluation Report of Disinfecting Products (2014), disinfection product should perform required tests to complete Safety Evaluation Report. Those testing should be conducted in local Disease Prevention and Control Centre (provincially). There are five Categories of disinfection products and each of them has specific test requirements. 

Category I: Disinfectant


Test Item

Disinfection objects

Skin

Mucosa

Hand

Tableware

Fruits and vegetables

Drinking water

Swimming pool water

Hospital waste water

Air

Medical device and consumable goods

General Object surface and textile fabrics

Others

Sterilization and high level disinfection

Mediate level disinfection

Low level disinfection

Appearance

Active ingredient content

pH value

Stability

Stability in continuous use

±

±

±

±

PbAsHg content

±

Mental corrosion test

±

±

±

±

±

Laboratory determination of microbial killing effect③④⑤

Simulated field tests or field trials

Toxicological safety testing

±

Overall performance test

Note: “+” means mandatory item, “-” means exempted item, “±” means optional item.

①Glutaraldehyde disinfectant shall measure the pH values before and after adding pH conditioning agent. If the product is solid, perform the test at the highest concentration.

②Tableware, drinking water, and fruits and vegetables only conduct Pb and As content test.

③Microbial killing test should be based on application scope and valid microbe written on the label and specification.

④For Ethanol disinfectant, glutaraldehyde disinfectant, sodium hypochloride disinfectant and bleaching powder disinfectant, if they are used for general object surfaces and textile fabrics, select staphylococcus aureus to conduct quantitative killing test; if they are used for sanitary wares, select candida albicans to conduct quantitative killing test; If they are used at drinking water, swimming pool water or waste water, should choose coli to perform quantitative test; if they are used for tableware, please conduct poliovirus quantitative inactivating test; if they are used for hands, skins or mucosa disinfection, please conduct candida albicans quantitative killing test; if they are used for medical devices and consumable goods sterilization or high level disinfection, please conduct bacterial spores quantitative killing test; if they are used for hands, skins or mucosa disinfection, please conduct candida albicans quantitative killing test while mediate level disinfection shall perform mycobacterium chelonae quantitative killing test; if they are used for air disinfection, please conduct staphylococcus albus quantitative killing test; other type disinfectants should choose a most resistant microorganism, which is decided by product label and specification, to perform efficacy test.

⑤The interfering substance concentration is 0.3% for sodium hypochloride disinfectant and disinfectant used after cleaning.

⑥The microbe used for medical device and consumable goods disinfectant (includes the disinfectant carried by nonwovens) simulated field test should choose the most resistant microbe according to application scope.

⑦Except Ethanol disinfectant, glutaraldehyde disinfectant, sodium hypochloride disinfectant and bleaching powder disinfectant, other disinfectants are required to conduct an acute oral toxicity test or an acute inhalation toxicity test and a mutagenicity test; if the disinfectant is used for hand or skin disinfection, more than once skin irritation trials are required; if the disinfectant is used at mucosa or broken skin, an eye irritation trail is required, if the disinfectant is used for vagina disinfection, a vagina irritation test is required. 

Category II: Disinfection Device/Equipment 


Test Items

Disinfection objects

Skin

Mucosa

Hand

Tableware

Fruits and vegetables

Drinking water

Swimming pool water

Hospital waste water

Air

Medical device and consuming goods

General Object surface and textile fabrics

Others

Sterilization and High level disinfection

Mediate level disinfection

Low level disinfection

Efficacy test of main disinfecting factor (includes changing curve)

±

PbAsHg content test(Only for chemical disinfecting factor device)

±

Metal corrosion test(Only for chemical disinfecting factor device))

±

±

±

±

±

±

Microorganism efficacy test in the lab

Simulated field tests or field trials

Toxicological safety testing

Overall performance test

Note: “+” means mandatory item, “-” means exempted item, “±” means optional item.

①Except ethylene oxide disinfection (sterilization) cabinet, low temperature plasma sterilization device and   LTSF sterilization cabinet, other disinfection device must conduct this test.

②Tableware, fruits and vegetables, and drinking water are only required to perform As, Pb content test.

③If the chemical factor disinfection device doesn‘t indicate it cannot be used at metal object in label or commercial specification, it must complete metal corrosion test.

④Ultraviolet lamp are not required to do efficacy test while other disinfectants conduct efficacy test .One-star tableware disinfection cabinet should conduct a coli quantitative killing test; two-star tableware cabinet should conduct a poliovirus quantitative killing test; pressure steam sterilizer should conduct a Bacillus stearothermophilus spore quantitative killing test.

⑤Simulated field test uses the most resistant microbe in the application scope.

⑥The disinfection device which generates disinfectant (except sodium hypochloride) should conduct an acute toxicity test or an acute inhalation toxicity test and a mutagenicity test; if the disinfection device is used for hand or skin disinfection, more than once skin irritation trials are required; if the disinfectant is used at mucosa or broken skin, an eye irritation trail is required.

 


Category III: Chemical Indicator&Biological Indicator


Test Items

Indicator card for Ultraviolet lamp radiation intensity

Disinfectant concentration test paper

Biological indicator

Sterilization chemical indicator

Microbe contents of BI

Survival time and killing time

D value

Color change of CI in the corresponding sterilization situation

Influence factor

Microorganism survival amount in corresponding disinfecting factor situation

Ultraviolet intensity test

Disinfectant concentration comparison

Stability

Others

±

±

Note: “+” means mandatory item, “-” means not required item, “±” means optional item.

①Includes a successful test and a failed test。

②Moist beat disinfection, low temperature hydrogen peroxide gas plasma sterilization, low temperature steam formaldehyde(LTSF) sterilization should use bacillus stearothermophilus spores as tested bacteria. Other disinfection factors should choose Bacillus subtilis variant as tested bacteria.

③Includes chemical indicators for sterilizing effect and chemical indicator for sterilizing process.


Table IV: Packaging materials for disinfected and sterilized product

Test Items

Packaging material

Paper

Non-paper

Breathable material

Non-breathable material

General check for packaging material

 

Packaging material sterilization period of validity test

 

Packaging material quality test

 

Sterilizing factor penetration test

 

Influence test for sterilizing on packaging label

 

Packaging material gas impermeability test

 

Microbial barrier test for breathable mateial

 

Microbial permeability test

 

Shelf life test for packaging material

Note: “+” means mandatory item, “-” means exempted item, “±” means optional item.


Category V: Antibacterial and Bacteriostatic Agent 

Test Items

Antibacterial Agent

Bacteriostatic Agent

Active ingredient content

Stability

pH Value

Microbial index:

Total bacterial colonies number

Coliform

Total fungal colonies number

Pathogenic purulent bacteria

 

 

Killing microbial index

Killing test for coli

Killing test for staphylococcus aureus

Killing test for candida albicans

Killing test for other microbe

Bacteriostatic index:

Bacteriostatic test for coli

Bacteriostatic test staphylococcus aureus

Bacteriostatic test candida albicans

Bacteriostatic test other microbe

 

±

±

 

 

 

±

±

Toxicity indicator test

Note: “+” means mandatory item, “-” means not required item, “±” means optional item.

①Only for chemical ingredient.

②Except cream products

③ The product which label or specification claims it is valid for fungi or used at genitals shall test this item.

④If label or specification claims the product can kill or inhibit a certain microbe, the product shall perform this test.

⑤If the label or specification claims the antibacterial or bacteriostatic agent used for skin, it should conduct skin irritation trail repeatedly; if the product requires rinsing after use, it just need to conduct acute skin irritation test which exposure time is 2 hours; If the label or specification claims the antibacterial or bacteriostatic agent used for mucosa, it should conduct eye irritation trail; If the label or specification claims the antibacterial or bacteriostatic agent used for vagina mucosa, it should conduct vagina mucosa irritation test.

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