Microbiological Efficacy Tests

The assessment of the efficacy of cleaning, hygiene, and healthcare products on microorganisms is possible through microbiological efficacy tests. Specifically, biocidal products, disinfectants, antiseptics, and certain cosmetics may not be placed on the market without these tests.

What is a microbiological efficacy test?

Microbiological efficacy tests are conducted to measure a product's bactericidal or inhibitory effect on bacteria, viruses, fungi, and other pathogenic microorganisms. These tests provide scientific evidence of whether the product is indeed effective against the target microorganisms.

Where are they applied?

• Biocidal Products (Disinfectants, Hand Sanitizers)
• Cosmetic and Dermocosmetic Products
• Medical Devices and Surface Disinfectants
• Food Processing Equipment and Hygiene Products
• Pharmaceutical Industry

Key Microbiological Efficacy Tests

1. Bactericidal Efficacy Test (EN 1276, EN 13727)

Determines the product's efficacy against bacteria.

Test Organisms: E. coli, Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus hirae

2. Fungicidal and Yeasticidal Efficacy Tests (EN 1650, EN 13624)

Analyzes efficacy against fungi, including yeasts and molds.

Test Organisms: Candida albicans, Aspergillus brasiliensis

3. Virucidal Efficacy Test (EN 14476)

The product's efficacy against viruses is measured.

Comprehensive virus models are utilized: Poliovirus, Adenovirus, Norovirus

4. Sporicidal Efficacy Test (EN 13704)

Efficacy against bacterial spores is particularly mandated for products in the healthcare sector.

Test Organism: Bacillus subtilis

5. Microbial Contamination Tests (Bioburden Analysis)

Quantifies microorganisms present in products during the production phase.

Scope of Analysis

• Assessment of Bactericidal Efficacy: EN 1276
• Assessment of Fungicidal Efficacy:  EN 1650
• Assessment of Bactericidal Efficacy in the Medical Field: EN 13727+A2
• Assessment of Fungicidal Efficacy in the Medical Field: EN 13624
• Assessment of Bactericidal Efficacy in the Veterinary Field: EN 1656
• Assessment of Fungicidal Efficacy in the Veterinary Field: EN 1657
• Assessment of Bactericidal Efficacy against Legionella: EN 13623
• Disinfectants for Swimming Pool Water and Whirlpools – Evaluation of Bactericidal Efficacy: OECD ENV JM MONO 2012 15
• Evaluation of Airborne Bactericidal Activity: EN 17272
• Evaluation of Bactericidal and/or Fungicidal Activity: TS EN 13697+A1
• Evaluation of Microbicidal Activity: EN 14348
• Evaluation of Microbicidal Efficacy for Veterinary Use: EN 14204
• Evaluation of Sporicidal Efficacy: EN 13704
• Evaluation of Bactericidal Efficacy for Medical Instruments: EN 14561
• Evaluation of Fungicidal Efficacy for Medical Instruments: EN 14562
• Evaluation of Microbicidal or Tuberculocidal Efficacy of Chemical Disinfectants and Antiseptics for Medical Instruments: EN 14563
• Evaluation of Bactericidal and Fungicidal Efficacy of Mechanically Agitated Wipes on Non-Porous Surfaces in the Medical Area (4-Field Test): EN 16615
• Evaluation of Virucidal Efficacy: EN 14476