Efficacy Tests

What is a Biological Efficacy Test?

Biological efficacy tests for biocidal products are experimental investigations that measure the killing or inhibitory effect of a product on specific microorganisms. These tests assess the microbial efficacy of the product under real-world application conditions.

The objective is to demonstrate that the product achieves the desired effect both in the laboratory and in practical application.

Areas of Application

Biological efficacy tests are mandatory or recommended for the following product groups:

• Hand and Skin Disinfectants
• Surface Disinfectants
• Disinfectants for Food Processing
• Disinfectants for the Medical Sector
• Biocidal Products for Animal Husbandry
• Water Disinfectants

Applied EN Standards

The efficacy of biocidal products in Europe is evaluated in accordance with EN standards. Some common standards include:

• Assessment of Bactericidal Activity

     –  S. aureus ATCC 6538
     –  P. aeruginosa ATCC 15442
     –  E. coli ATCC 10536
     –  E. hirae ATCC 10541
     –  M. avium ATCC 15769
     –  M. terrae ATCC 15755

• Assessment of Fungicidal and Yeasticidal Activity
  –  C. albicans ATCC 10231
  –  Aspergillus brasiliensis ATCC 16404
• Assessment of Sporicidal Activity
  –  B. subtilis ATCC 6633
• Assessment of Virucidal Activity
  –  Poliovirus Type 1, L
  –  Adenovirus Type 5, Strain Adenoid 75, ATCC VR-5
  –  Murine Norovirus, Strain S99 Berlin
  –  Bacteriophage P001, Bacteriophage P008
• Assessment of Bactericidal Activity against Legionella
• Assessment of Mycobactericidal and Tuberculocidal Activity
  –  Mycobacterium avium
  –  Mycobacterium intracellulare (MAI)
  –  Mycobacterium kansasii
  –  Mycobacterium chelonae
• Assessment of Bactericidal Activity
• Quantitative Carrier Test for the Evaluation of Bactericidal Activity of Instruments for Medical Use
  –  EN 14561: Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of bactericidal activity of instruments for medical use. Test method and requirements (Phase 2, Step 2)
• Quantitative Carrier Test for the Evaluation of Fungicidal and Yeasticidal Activity of Instruments for Medical Use
  –  EN 14562: Chemical disinfectants and antiseptics – Quantitative carrier test methods for the evaluation of fungicidal or yeasticidal activity of instruments for the medical area – Test method and requirements (Phase 2, Step 2)
• Quantitative Carrier Tests for the Evaluation of Mycobactericidal or Tuberculocidal Properties of Chemical Disinfectants and Antiseptics for Instruments in the Medical Area
  –  EN 14563: Chemical disinfectants and antiseptics – Quantitative carrier tests for the evaluation of mycobactericidal or tuberculocidal activity of chemical –  disinfectants for instruments in the medical area – Test method and requirements (Phase 2, Step 2)
• Quantitative Test Method for the Evaluation of Bactericidal and Yeasticidal Activity on Non-Porous Surfaces Using Mechanically Operated Wipes in the Medical Area (4-Field Test)
  –  EN 16615: Chemical disinfectants and antiseptics. Quantitative test method for the evaluation of bactericidal and yeasticidal activity on mechanically acting, non-porous surfaces treated with wipes in the medical area (4-Field Test). Test method and requirements (Phase 2, Step 2)
• Assessment of the Efficacy of Film Preservatives Against Fungi on Coatings
  –  EN 15457: Paints and varnishes – Laboratory method for testing the efficacy of film preservatives against fungi in coatings