China NHC Released Hygienic Standard for Efficacy Tests of Antimicrobial Products

13 efficacy evaluation methods have been established for commonly used but legally grey-zone antimicrobial products such as hand cleaner, sprays, gels, wet wipe, facial mask, sanitary towel, diaper, towel, underwear, socks, fabric, plastics, floorboards and tiles, etc.

Once NHC made adequate clarification on product definition/scope, necessity of risk/safety assessment and relevant evaluation guidelines, these products are likely to be brought into stringent supervision

China NHC Released Hygienic Standards for Efficacy Evaluation of Antimicrobial ProductsOn 30 Jan 2019, the National Health Commission published 6 voluntary hygienic standards for biocidal products, which will take effect on 1 Jul 2019. Among them, the “WS/T 650-2019 Evaluating Method for Efficacy of Antibacterial and Bacteriostasis” was firstly issued. The standard specifies 13 testing methods, procedures the application scope and criteria for commonly used items with antimicrobial claim including hand cleaner, sprays, gels, wet wipe, facial mask, sanitary towel, diaper, towel, underwear, socks, fabric, plastics, floorboards and tiles, etc. These antimicrobial products are mostly categorized as the Category II disinfection products but comparatively in a regulatory grey zone because most of them are not yet included into the pre-marketing assessment. Considering the complicacy of product type and feature, WS/T 650-2019 can be an evident progress and these commonly used antimicrobial products are likely to be brought into supervision after NHC made adequate clarification on product definition/scope, necessity of risk/safety assessment and relevant evaluation guidelines.

Hygienic Standards to be Enforced on 1 Jul 2019

Code

Title

WS/T 646-2019

Hygienic requirement for sodium percarbonate disinfectant

过碳酸钠消毒剂卫生要求

WS/T 647-2019

Hygienic requirement for lysostaphin and lysozyme disinfectants

溶葡萄球菌酶和溶菌酶消毒剂卫生要求

WS/T 648-2019

General hygienic requirement for air disinfecting machine

空气消毒机通用卫生要求

WS/T 649-2019

Hygienic requirement on low-temperature steam and formaldehyde sterilizers for medical purpose

医用低温蒸汽甲醛灭菌器卫生要求

WS/T 650-2019

Evaluating method for efficacy of antibacterial and bacteriostasis

抗菌和抑菌效果评价方法

WS/T 651-2019

Evaluation requirement on indicators for low-temperature steam and formaldehyde sterilization processes for medical purpose

医用低温蒸汽甲醛灭菌指示物评价要求

Efficacy Evaluation of Antimicrobial Products

Test Method

Applicable Scope(Test item)

Bacteriostasis Effect:

(stops bacteria from reproducing, while not necessarily killing them otherwise)

Quantitative bacteriostasis test using suspension method

Liquid bacteriostatic agents such as sanitary lotion and sprays, etc.

Quantitative bacteriostasis test using carrier immersion method

Pasty or half-solid bacteriostatic agents such as gel and cream, etc.

Carrier bacteriostasis test

Solid bacteriostatic products containing dissoluble bacteriostatic substance, such as non-woven mask, sanitary towel, sanitary pad and diaper, etc.

Inhibition zone test

Platelike solid bacteriostatic products 5 millimeters wide and qualitative determination of dissoluble bacteriostatic substance in antimicrobial products;

bacteriostasis test using infiltration method

Fabric products containing dissoluble bacteriostatic substance, such as bacteriostatic towel, facial mask and underwear, etc.

Persistent bacteriostasis test

washing liquors with persistent bacteriostatic effect;

Antibacterial Effect:

destroys or inhibits the growth of microorganisms and especially pathogenic microorganisms

Quantitative bactericidal test using suspension method

Liquid antibacterial agents such as sanitary lotion and sprays, etc.

Quantitative bactericidal test using carrier immersion method

sticky or half-solid antibacterial agents such as antimicrobial hand cleanser, shower gel, antimicrobial gel and cream, etc.

Carrier bactericidal test

hygienic wet wipe and other carrier products containing dissoluble bactericidal substance, such as

Bactericidal test using infiltration method

Fabric products containing dissoluble antibacterial substance, such as bacteriostatic towel, soaks, cotton cloth and cotton cloth respirator, etc.

Shake flask method

Antibacterial products containing non-dissoluble antibacterial substance

Film test

PE films, PE porous films,  antimicrobial PE packing bag, plastic, floorboards and tiles, etc.

Persistent bactericidal test

Antimicrobial products with persistent bacteriostatic effect;

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