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Home » ALG Compliance Tests » International Tests

International Tests

Liquid Antimicrobial Efficacy

EN 13727 Chemical Disinfectants and Antiseptics: Quantitative Suspension Test for the Evaluation of Bactericidal Activity for Activity for Instruments Used in the Medical Area

The EN method is designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus hirae

EN 13624 Chemical Disinfectants and Antiseptics: Quantitative Suspension Test for the Evaluation of Fungicidal or Yeasticidal Activity for Instruments used in the Medical Area

The EN method below is designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Candida albicans, Aspergillus brasiliensis

EN 14348 Chemical Disinfectants and Antiseptics: Quantitative Test for Basic Mycobactericidal Activity

The EN method below is designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Mycobacterium avium, Mycobacterium terrae

AOAC Method 966.04 Sporicidal Activity of Disinfectants

In this method, a series of porcelain cylinders and silk or Dacron sutures (“carriers”) are inoculated with the spores of Bacillus subtilis and Clostridium sporogenes and are desiccated. The carriers containing the dried spore film are then sequentially immersed into 10 mL of disinfectant and are exposed to the disinfectant for a predetermined exposure time. After exposure, the carriers are sequentially transferred to a liquid subculture medium specifically selected to neutralize the test substance active and to recover any surviving spores. The carriers are incubated and visually examined for the presence or absence of growth. Based on the desired claim and the requirements of the regulatory agency, the product must demonstrate kill on a predetermined number of carriers inoculated with test organisms applicable to the claim.

Quantitative Tuberculocidal Suspension Method

In this method, quadruplicate samples of the product are inoculated with a suspension of Mycobacterium bovis – BCG. The inoculated products are allowed to expose for a series of exposure times. After each exposure time, a sample of product is removed, neutralized and is quantitatively assayed for surviving Mycobacterium. A percent reduction is determined for the test samples, at each time point, as compared to a population control. The U.S. EPA requires an effective product demonstrate at least a 99.99% (4 log10) reduction of Mycobacterium and an average of <1 survivor at the effective time. For high-level disinfectants, the U.S. FDA requires an effective product demonstrate at least a 99.9999% (6 log10) reduction of Mycobacterium and an average of <1 survivor at the effective time. When the minimum reduction is not met at any of the times utilized in the study, a survivor curve can be constructed to predict the effective time of the product.[/expand] [expand title="EN 1040 Basic Bactericidal Activity of Chemical Disinfectants"]The EN method below are designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control. Test Organisms: Staphylococcus aureus, Pseudomonas aeruginosa

EN 1275 Quantitative Suspension Test for the Evaluation of Basic Fungicidal or Basic Yeasticidal Activity of Chemical Disinfectants

Summary of Test
The EN 1275 Quantitative Suspension Test for the Evaluation of Basic Fungicidal or Basic Yeasticidal Activity of Chemical Disinfectants method is designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Candida albicans, Aspergillus brasiliensis

EN 1276 Quantitative Suspension Test for the Evaluation of Bactericidal Activity of Chemical Disinfectants

The EN method below are designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus hirae, Escherichia coli

EN 13697 Quantitative Surface Test for the Evaluation of Bactericidal or Fungicidal Activity

The EN method below are designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus hirae, Escherichia coli, Candida albicans, Aspergillus brasiliensis

EN 1650 Quantitative Suspension Test for the Evaluation of Fungicidal Activity of Chemical Disinfectants

The EN method below are designed to evaluate the bactericidal, fungicidal, yeasticidal, basic sporicidal or mycobactericidal activity of a product used under various conditions. Many methods are suspension based and are used to support general antimicrobial claims while other test methods are carrier-based and are used to support antimicrobial activity of products on surfaces or devices. In either case, the same general principles apply. The test organism is exposed to sample of the product in a manner which simulates the desired claim. Following exposure, the test system is neutralized and quantitatively assayed for survivors. The resulting plates are incubated, enumerated, and a reduction in viability or microbiocidal effect is determined as compared to a population control.

Test Organisms: Candida albicans, Aspergillus brasiliensis

Virology Testing

EN 14476 Chemical Disinfectants and Antiseptics - Quantitative Suspension Test for the Evaluation of Virucidal Activity in the Medical Area - Test Method and Requirements (Phase 2, Step 1)

A suspension of virus is added to a solution of interfering substances; the interfering substance used is dependent on the product claim. The prepared test product is added to the suspension of virus in interfering substance and is maintained at the requested temperature for the requested exposure time(s). At the end of the exposure time, aliquots are taken and the virucidal activity against the test virus is immediately neutralized or suppressed by dilution in ice-cold test medium. Serial dilutions are performed and the dilutions are then assayed for viral infectivity by an assay method specific for the testing virus. Appropriate controls are performed in parallel with the assay. Reduction of virus infectivity is calculated from differences of log virus titers before and after treatment with the product.

Test Organisms: Adenovirus, Poliovirus, Parvovirus, Murine Norovirus, and additional pathogens may be tested.

EN 14675 Chemical Disinfectants and Antiseptics - Quantitative Suspension Test for the Evaluation of Virucidal Activity of Chemical Disinfectants and Antiseptics used in the Veterinary Area - Test Method and Requirements (Phase 2, Step 1)

A suspension of virus is added to a solution of interfering substances; the interfering substance used is dependent on the product claim. The prepared test product is added to the suspension of virus in interfering substance and is maintained at the requested temperature for the requested exposure time(s). At the end of the exposure time, aliquots are taken and the virucidal activity against the test virus is immediately neutralized or suppressed by dilution in ice-cold test medium. Serial dilutions are performed and the dilutions are then assayed for viral infectivity by an assay method specific for the testing virus. Appropriate controls are performed in parallel with the assay. Reduction of virus infectivity is calculated from differences of log virus titers before and after treatment with the product.

Test Organisms: Bovine Enterovirus type 1 and additional pathogens

JIS Z 2801 / ISO 22196 (Modification) – Japanese Industrial Standard Test for Determining Antiviral Activity

In these methods, treated test samples and untreated control samples are inoculated with the test virus. The test virus is held in place under a flexible coverslip and the samples are allowed to expose at the requested exposure temperature and the requested exposure time. Following exposure, the samples are neutralized, serial dilutions are performed of the neutralized solution and the dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently. The percent and log reduction in viral infectivity are calculated as compared to the corresponding virus control. No regulated performance criteria currently exist for antiviral claims made using these methods.