BS EN 13727 Chemical disinfectants and antiseptics . Quantitative suspension test for evaluation of bactericidal activity for medical use . Test methods and requirements ( Phase 2 Step 1 )
BS EN 1500 Chemical disinfectants and antiseptics . Test methods and requirements for hand washing in hygiene ( Phase 2 / Step 2 )
Routine testing standards for hand sanitizers include:
QB/T 2738 "Evaluation Method for Antibacterial and Bacteriostatic Effect of Daily Chemical Products"
EN 1276 "Quantitative suspension test for testing the bactericidal effect of disinfectants and preservatives in equipment used in the food industry, industry, household and public places"
EN 1650 "Quantitative suspension test for the action of disinfectants and preservatives on fungi in equipment used in the food industry, industry, household and public places"
EN1499 "Chemical disinfectants and preservatives . Disinfectant hand sanitizers . Inspection methods and requirements"
EN1500 "Chemical sterilants and disinfectants . Hand friction hygiene . Test methods and regulations"
EN13727 "Chemical disinfectants and preservatives . Quantitative suspension test . Test methods and requirements"
Currently, most hand sanitizers sold in Europe are for sterilization. In order to prove the sterilization effect of the product, EN 1500 and EN 13727 sterilization effect tests are required.
EN 1500 Test item test name : Hygienic handrub hand sanitizer antibacterial test
EN 1500 test content : Disinfectant hand disinfection simulation field test is a comparative test in which samples and reference samples are subjected to hand simulation tests . The test process requires 30 volunteers. All volunteers need to use the sample after their hands are infected with bacteria. Sterilize with the reference sample, then count the bacteria remaining on the hands , perform statistical analysis on the counts and evaluate the effect of the sample.
Involving standards and targeted strains :
EN 1040 Stage 1 bacterial sterilization test standard
EN 1275 Stage 1 fungal bactericidal test standard
A bacterial sterilization test standard for EN 1276 Phase 2
EN 1650 Stage 2 test standard for a fungal bactericidal test
EN 1040 Chemical disinfectants and antiseptics
The first stage of bacterial sterilization test, the default bacterial species : Pseudomonas aeruginosa and Staphylococcus aureus.
EN 1275 Chemical disinfectants and antiseptics
In the first stage of the fungal sterilization test, regardless of the test environment, the default strains are : Aspergillus brasiliensis and Candida albicans.
EN 1276 Chemical disinfectants and antiseptics Sprayers and liquid fertilizer distributors
The second stage of bacterial sterilization test is divided into dirty environment and clean environment. The default bacterial species are : Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus heisenbergii.
EN 1650 Fungicidal Testing of Chemical Disinfectants and Preservatives,
The second stage of bacterial sterilization test is divided into dirty environment and clean environment. The default strains are : Aspergillus brasiliensis and Candida albicans.
EN 1500 standard catalog:
1 Scope
2 Reference standards
3Terms and Definitions
4 requirements
5 test methods
5.1 Principles
5.2 Materials and reagents
5.2.1 Test organisms
5.2.2 Culture media and reagents
5.3 Instruments and glassware
5.3.1 General
5.3.2 Commonly used microbiology laboratory equipment, especially the following equipment
5.4 Preparing test organism suspensions and product testing solutions
5.4.1 Testing organism suspensions ( Test and Validation Suspensions )
5.4.2 Product testing solutions
5.5 Evaluation of product sterilization procedures on volunteers’ hands
5.5.1 General instructions
5.5.2 Neutralization – Control and Confirmation
5.5.3 Volunteer testing process
5.5.4 Incubation and calculation of test mixtures, control mixtures and verification mixtures
5.6 Experimental data and calculations
5.6.1 Interpretation of terms and abbreviations
5.6.2 Calculation
5.7 Verification method — Test confirmation
5.7.1 Acceptance criteria are test results
5.7.2 Controlling weighted average counts
5.7.3 Basic restrictions
5.8 Statistical evaluation ( tests of significance ), results and accuracy of expressions
5.9 Conclusion
5.10 Issue test report
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