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Efficacy Data to Support Disinfection Claims and Global Regulatory Submissions

Medical disinfectants and antiseptics must demonstrate reliable antimicrobial performance for use on surfaces, instruments and textiles in healthcare and professional environments.

Hohenstein provides independent laboratory testing using internationally recognized EN/European methods, including quantitative suspension tests (phase 2/stage 1) and practical carrier tests (phase 2/stage 2). These methods are widely used to verify bactericidal, fungicidal, levurocidal, mycobactericidal, tuberculocidal and virucidal efficacy for global product claims and infection-control applications.

Testing supports medical-device manufacturers, healthcare facilities, disinfectant brands and institutional users that require defensible efficacy data for product development, quality documentation and global market needs.

Why test with Hohenstein?

Clear, defensible data to verify disinfectant effectiveness in medical applications.
  • Quantitative suspension tests and practical carrier tests (phase 2/stage 1 and phase 2/stage 2)
  • ISO/IEC 17025 accredited and GLP-certified execution
  • Support for bactericidal, levurocidal, fungicidal, tuberculocidal, mycobactericidal and virucidal claims
  • Applicable for global disinfectant submissions and product validation

Disinfection Efficacy Tests for Medical Products

Surface Disinfection - Spraying

Surface Disinfection Testing - Spray Applications

Test Methods:
  • VAH method 8
    Determination of bactericidal and levurocidal efficacy in qualitative suspension test (phase 1)
  • VAH method 9
    Determination of bactericidal, levurocidal, fungicidal, tuberculocidal and mycobactericidal efficacy in quantitative suspension test (phase 2, stage 1)
  • VAH Method 14.1
    Surface disinfection without mechanical action – practical test (phase 2, stage 2)
  • EN 13727 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining bactericidal efficacy in human medicine – test methods and requirements (phase 2, step 1)
  • EN 13624 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the fungicidal or levurocidal effect in human medicine – test method and requirements (phase 2, step 1)
  • EN 14348 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the mycobactericidal activity of chemical disinfectants in human medicine, including instrument disinfectants – Test method and requirements (phase 2, step 1)
  • EN 17387 Chemical disinfectants and antiseptics
    Quantitative test for determining the bactericidal and levurocidal and/or fungicidal activity of chemical disinfectants in human medicine on non-porous surfaces without mechanical action - Test methods and requirements (phase 2, step 2)
Surface Disinfection - Wiping

Surface Disinfection Testing - Wipe Applications

Test Methods:
  • VAH method 8
    Determination of bactericidal and levurocidal efficacy in qualitative suspension test (phase 1)
  • VAH method 9
    Determination of bactericidal, levurocidal, fungicidal, tuberculocidal and mycobactericidal efficacy in quantitative suspension test (phase 2, stage 1)
  • VAH method 14.2
    Surface disinfection using mechanical means – practical test (phase 2, stage 2)
  • EN 13727 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining bactericidal efficacy in human medicine – test methods and requirements (phase 2, step 1)
  • EN 13624 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the fungicidal or levurocidal effect in human medicine – test method and requirements (phase 2, step 1)
  • EN 14348 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the mycobactericidal activity of chemical disinfectants in human medicine, including instrument disinfectants – Test method and requirements (phase 2, step 1)
  • EN 16615 Chemical disinfectants and antiseptics
    Quantitative test method for determining the bactericidal and levurocidal effect on non-porous surfaces with mechanical action using wipes in human medicine (4-field test) - Test methods and requirements (phase 2, step 2)
Instrument Disinfection

Instrument Disinfection Testing

Test Methods:
  • VAH Method 8
    Determination of bactericidal and levurocidal efficacy in qualitative suspension test (phase 1)
  • VAH Method 9
    Determination of bactericidal, levurocidal, fungicidal, tuberculocidal and mycobactericidal efficacy in quantitative suspension tests (phase 2, stage 1)
  • VAH Method 15
    Chemical/chemothermal instrument disinfection – practical quantitative germ carrier test (phase 2, stage 2)
  • EN 13727 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining bactericidal activity in human medicine – test methods and requirements (phase 2, step 1)
  • EN 13624 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the fungicidal or levurocidal effect in human medicine – test method and requirements (phase 2, step 1)
  • EN 14348 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the mycobactericidal effect of chemical disinfectants in human medicine, including instrument disinfectants – Test method and requirements (phase 2, step 1)
  • EN 14561 Chemical disinfectants and antiseptics
    Quantitative sponge test for testing the bactericidal effect for instruments in human medicine – test methods and requirements (phase 2, step 2)
  • EN 14562 Chemical disinfectants and antiseptics
    Quantitative bioassay for testing the fungicidal or levurocidal effect of instruments in human medicine – Test method and requirements (phase 2, step 2)
  • EN 14563 Chemical disinfectants and antiseptics
    Quantitative germ carrier test for testing the mycobactericidal or tuberculocidal effect of chemical disinfectants for instruments in human medicine – Test method and requirements (phase 2, step 2)
Laundry Disinfection

Laundry Disinfection Testing

Test Methods:
  • VAH Method 8
    Determination of bactericidal and levurocidal efficacy in qualitative suspension test (phase 1)
  • VAH Method 9
    Determination of bactericidal, levurocidal, fungicidal, tuberculocidal and mycobactericidal efficacy in quantitative suspension tests (phase 2, stage 1)
  • VAH Method 17 Chemothermal laundry disinfection
    Single-bath method (practical test) (phase 2, stage 2)
  • EN 13727 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining bactericidal activity in human medicine – test methods and requirements (phase 2, step 1)
  • EN 13624 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the fungicidal or levurocidal effect in human medicine – test method and requirements (phase 2, step 1)
  • EN 14348 Chemical disinfectants and antiseptics
    Quantitative suspension test for determining the mycobactericidal effect of chemical disinfectants in human medicine, including instrument disinfectants – Test methods and requirements (phase 2, step 1)
  • EN 16616 Chemical disinfectants and antiseptics
    Chemothermal laundry disinfection – test methods and requirements (phase 2, step 2)
  • Testing the virucidal efficacy of disinfectants in chemothermal laundry disinfection (practical test)
    In-house method with surrogate virus MS2 according to SOP-QM-11.HY.03.055 & SOP-QM-11.HY.03.056 in conjunction with VAH method 17 (phase 2, stage 2)
Contact
Ben Mead
Managing Director
Hohenstein Americas