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    EN Standards & Efficacy Testing

    Overview of all European standards for testing the efficacy of disinfectants in human medicine

    European Standards for Surface Disinfection

    The efficacy of disinfectants is tested according to European standards (EN) in two phases. These tests substantiate the efficacy claims against various pathogens in the field of human medicine.

    Phase 2, Step 1

    Quantitative suspension test: Efficacy is tested in the laboratory under standardized conditions. The active substance is brought into direct contact with the pathogen.

    Phase 2, Step 2

    Practice-oriented test: Efficacy is tested under simulated practical conditions – e.g. with the 4-field test (EN 16615) on surfaces with and without mechanical action.

    Efficacy Spectra & Associated EN Standards

    Complete overview of tests for substantiating efficacy claims according to EN in human medicine

    Bactericidal

    effective against bacteria

    Phase 2, Step 1 (Suspension Test)

    EN 13727: Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus hirae

    Phase 2, Step 2 (Practice-Oriented Test)

    EN 1499 (hygienic hand washing) / EN 1500 (hygienic hand disinfection): Escherichia coli K12; EN 12791 (surgical hand disinfection): resident skin flora

    Basic Efficacy

    basic antimicrobial activity

    Phase 2, Step 1 (Suspension Test)

    EN 17387 (surface without mechanical action): S. aureus, P. aeruginosa, E. hirae

    Phase 2, Step 2 (Practice-Oriented Test)

    EN 16615 (4-field test with mechanical action): S. aureus, P. aeruginosa, E. hirae

    Levurocidal

    effective against yeasts

    Phase 2, Step 1 (Suspension Test)

    EN 13624: Candida albicans

    Phase 2, Step 2 (Practice-Oriented Test)

    EN 17387 (without mech.) / EN 16615 (with mech.): C. albicans

    Fungicidal

    effective against fungi

    Phase 2, Step 1 (Suspension Test)

    EN 13624: C. albicans, Aspergillus brasiliensis

    Phase 2, Step 2 (Practice-Oriented Test)

    EN 17387 / prEN 16615 (draft 2022-12): C. albicans, A. brasiliensis

    Tuberculocidal

    effective against tuberculosis bacteria

    Phase 2, Step 1 (Suspension Test)

    EN 14348: Mycobacterium terrae

    Phase 2, Step 2 (Practice-Oriented Test)

    prEN 16615 (draft 2022-12): M. terrae

    Mycobactericidal

    effective against mycobacteria incl. tuberculosis

    Phase 2, Step 1 (Suspension Test)

    EN 14348: M. terrae, M. avium

    Phase 2, Step 2 (Practice-Oriented Test)

    prEN 16615 (draft 2022-12): M. terrae, M. avium

    Limited virucidal

    effective against enveloped viruses

    Phase 2, Step 1 (Suspension Test)

    EN 14476: Vaccinia virus (MVA / Elstree)

    Phase 2, Step 2 (Practice-Oriented Test)

    Vaccinia virus (MVA / Elstree)

    Limited virucidal PLUS

    effective against enveloped viruses + rota-, adeno- and noroviruses

    Phase 2, Step 1 (Suspension Test)

    EN 14476: Adeno-, Norovirus (MNV)

    Phase 2, Step 2 (Practice-Oriented Test)

    Norovirus (MNV) [only valid with EN 14476]; EN 16777 (without mech.): Adeno-, Norovirus (MNV)

    Virucidal

    effective against enveloped and non-enveloped viruses

    Phase 2, Step 1 (Suspension Test)

    EN 14476: Adeno-, Noro- (MNV), Poliovirus

    Phase 2, Step 2 (Practice-Oriented Test)

    Norovirus (MNV) [only valid with EN 14476]; EN 16777 (without mech.): Adeno-, Noro- (MNV) [only valid with EN 14476]

    Sporicidal (C. difficile)

    effective against C. difficile spores

    Phase 2, Step 1 (Suspension Test)

    EN 17126 (surface, instruments): Clostridioides difficile

    Phase 2, Step 2 (Practice-Oriented Test)

    EN 17846 (surface with mech.): C. difficile

    Sporicidal

    effective against spores

    Phase 2, Step 1 (Suspension Test)

    EN 17126 (surface, instruments): Bacillus cereus, B. subtilis

    Phase 2, Step 2 (Practice-Oriented Test)

    –

    Without mechanical action: Spraying without subsequent wiping. This test does not allow conclusions about the efficacy of surface disinfection wipes.

    4-FIELD TEST

    The 4-Field Test

    Efficacy Under Real-World Conditions

    The 4-field test is a standardised laboratory method that simulates real surface contamination and wiping processes. It evaluates cleaning and disinfection performance simultaneously, delivering practice-relevant results.

    1

    Contaminated Surface

    High microbial load on the test surface

    2

    Transfer by Wiping

    Simulation of contamination spread

    3

    Reduction by Active Agent

    Disinfection effect begins

    4

    Efficacy Assessment

    Residual microbial load is measured

    Wipe Movement
    01

    Contamination

    The test surface is inoculated with microorganisms.

    02

    Wiping Process

    A wipe distributes contamination across multiple fields.

    03

    Contact Time

    The disinfectant acts during the wiping process.

    04

    Evaluation

    Germ reduction is measured across all fields.

    Why Is the 4-Field Test So Important?

    Simulates real-world application - not just laboratory conditions
    Reveals transfer risks during wiping
    Evaluates cleaning AND disinfection simultaneously
    Critical difference to classical suspension tests

    What Does This Mean in Practice?

    Products must not only kill germs but also prevent transfer.
    System solutions (wipe + active agent + application) are crucial.
    Error sources often arise from incorrect processes, not just incorrect products.

    Limitations of the 4-Field Test

    Standardised conditions do not reflect all real-world risks.
    Complementary assessment approaches are advisable.
    Practical validation remains indispensable.

    Why are these standards important?

    EN standards form the basis for the approval and evaluation of disinfectants in Europe. They ensure comparable, reproducible efficacy testing.

    Patient Safety

    Standards-compliant disinfection protects patients from nosocomial infections.

    Legal Compliance

    Adherence to EN standards is a prerequisite for approval and compliance.

    Comparability

    Standardized testing enables objective product comparisons.

    Learn more about modern hygiene assessment

    Overview of all European standards for testing the efficacy of disinfectants in human medicine

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