Efficacy studies demonstrate the ability of a biocide to eliminate or reduce specific target organisms. These studies are essential to verify claims.

Mérieux NutriSciences | Pharma & HealthCare regularly conducts studies to evaluate the efficacy of biocides. All studies are conducted according to international guidelines and the protocols comply with ISO 17025 or GLP quality standards.

Our project managers are part of the CEN/TC working group for efficacy testing of disinfectants:

• CEN/TC 216/WG 1 – Human medicine
• CEN/TC 216/WG 5 – Strategy group
• ​​CEN/TC 216/WG 2 – Veterinary use
• CEN/TC 216/WG 3 – Food hygiene and domestic and institutional use

Application areas

Medical area: hospitals, infirmaries, kitchens that prepare food for patients
▪ EN 13727
▪ EN 13624
▪ EN 14561
▪ EN 14562
▪ EN 14563
▪ EN 14348
▪ EN 16615
▪ EN 17126
▪ EN 12791
▪ EN 17387
▪ EN 1499
▪ EN 1500
▪ EN 14476
▪ EN 16777
▪ EN 17111

Veterinary area: breeding, veterinarians, production and transport of animals
▪ EN 1656
▪ EN 1657
▪ EN 14349
▪ EN 16438
▪ EN 14204
▪ EN 16437
▪ EN 14675

Domestic, industrial, food and institutional areas: production, distribution and sale of food, schools, hotels, offices

• EN 1656
• EN 1657
• EN 14349
• EN 16438
• EN 14204
• EN 16437

Standardized protocols

The methodologies follow European standards (EN) and include tests for different conditions of use, such as surfaces, water and air. The following efficacy tests are available for disinfectants (PT 1 to PT 5)*:

Bactericidal efficacy test

• EN 1276 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the bactericidal activity of chemical disinfectants and antiseptics used in the food, industrial, domestic and institutional sectors – Test method and requirements (phase 2, stage 1). The standard defines a test method and minimum requirements for the bactericidal activity of homogeneous and stable chemical disinfectants and antiseptics, diluted with hard water or ready for use. It applies to products for food, industrial, domestic and institutional use, excluding medical contexts and use on living tissue, except for hand hygiene in these contexts.
• EN 13697 Chemical disinfectants and antiseptics – Quantitative test on non-porous surfaces for the evaluation of the bactericidal activity of chemical disinfectants used in the food, industrial, domestic and institutional sectors, without mechanical action – Test method and requirements without mechanical action (phase 2, stage 2). The standard defines a test method (phase 2, stage 2) and the minimum requirements for evaluating the bactericidal activity of stable and homogeneous chemical disinfectants and antiseptics, diluted in hard water or ready for use. It is applicable to products used in the food, industrial, domestic and institutional sectors, excluding medical contexts, use on living tissue and surfaces disinfected by mechanical action. It applies to the disinfection of non- porous surfaces in processes such as the distribution and sale of food of animal origin, dairy products, meat, fish and pet food.
• EN 1499 Chemical disinfectants and antiseptics – Hygienic hand washing – Test method and requirements (phase 2, stage 2). The standard describes a test method simulating practical conditions to assess whether a hygienic hand wash reduces the transient bacterial flora on artificially contaminated hands of volunteers.
• EN 1500 Chemical disinfectants and antiseptics – Hygienic hand treatment by friction – Test method and requirements (phase 2, stage 2). The standard defines a test method that simulates practical conditions to evaluate whether a product for the hygienic treatment of hands by friction reduces the transient bacterial flora on the hands of artificially contaminated volunteers.
• EN 12791 Chemical disinfectants and antiseptics – Surgical hand disinfection – Test method and requirements (phase 2, stage 2). The standard defines a test method that simulates practical conditions to evaluate whether a product for surgical hand rubbing or washing reduces the resident bacterial flora and, where applicable, the transient bacterial flora on the clean hands of volunteers.
• EN 13727 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, stage 1). The standard establishes a test method and minimum requirements for evaluating the bactericidal activity of chemical disinfectants and antiseptics, ensuring that they are physically stable and homogeneous when diluted in hard water or, for ready-to- use products, in water.
• EN 14561 Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, stage 2). The standard defines a test method and minimum requirements for evaluating the bactericidal activity of chemical disinfectants, ensuring that they are homogeneous and physically stable when diluted in hard water or, for ready-to- use products, in water.
• EN 13623 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the bactericidal activity of chemical disinfectants, in aqueous solution, against Legionella – Test method and requirements (phase 2, stage 1). The standard defines a test method and minimum requirements for evaluating the bactericidal activity of chemical disinfectants in aqueous solution, stable and homogeneous when diluted in hard or ferrous hard water, against Legionella pneumophila. It is applicable for the treatment of waters where the presence of Legionella represents a risk to human health, such as cooling towers, spas, swimming pools and showers.
• EN 1040 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the basic bactericidal activity of chemical disinfectants and antiseptics – Test method and requirements (phase 1). The standard defines a test method and minimum requirements for evaluating the basic bactericidal activity of chemical disinfectants and antiseptics, ensuring that they are physically stable and homogeneous when diluted with water.
• EN 16615 Chemical disinfectants and antiseptics – Quantitative test for the evaluation of bactericidal and levuricide activity on non-porous surfaces with mechanical action using wipes in medical areas (4-field test) – Test method and requirements (phase 2, stage 2). The standard defines a test method and minimum requirements for evaluating the bactericidal and levuricide activity of chemical disinfectants, ensuring that they are stable and homogeneous when diluted in hard water or, for ready-to-use products, in water. It applies to products intended for the disinfection of non-porous surfaces in medical areas, including those of medical devices, using mechanical action wipes, regardless of the coverage of Directive 93/42/EEC.
• ISO 22196 Measurement of antibacterial activity on plastics and other non-porous surfaces. ISO 22196 specifies a method for evaluating the antibacterial activity of antibacterial-treated plastic surfaces and other non-porous surfaces of products (including intermediates).
• ASTM E2180 Standard test method for the determination of activity of antimicrobial agents incorporated into polymeric or hydrophobic materials. This test method is designed to quantitatively evaluate the antimicrobial efficacy of agents incorporated into or bound to predominantly flat (two-dimensional), hydrophobic or polymeric surfaces. The method focuses primarily on the evaluation of antibacterial activity, but can also be used to test other microorganisms, such as yeasts and fungal conidia.
• ASTM E2274 Standard test method for the evaluation of laundry sanitizers and disinfectants. This test method is designed to evaluate laundry detergents/sanitizers or disinfectants intended for use in conventional top-loading washing machines. The method is primarily designed to test representative vegetative bacteria, but may be adapted to include testing for fungi and viruses.
• ASTM E2406 Standard test method for evaluation of laundry sanitizers and disinfectants for use in high-efficiency washing operations. This test method is designed to evaluate laundry detergents/sanitizers or disinfectants intended for use in front-loading, high- efficiency (HE) washing machines, which use very small volumes of wash water. The method is primarily designed to test representative vegetative bacteria, but may be adapted to include testing for fungi and viruses.
• EN 1656 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary medicine – Test method and requirements (phase 2, step 1). The standard defines a test method and minimum requirements for evaluating the bactericidal activity of chemical disinfectants and antiseptics, ensuring that they are homogeneous and physically stable when diluted with hard water or, for ready-to-use products, with water. Products can only be tested at concentrations of 80% or less due to the dilution required with the addition of the test organisms. The method evaluates the efficacy of commercial formulations or active substances under the conditions of use.
• EN 14349 Chemical disinfectants and antiseptics – Quantitative surface test for the evaluation of the bactericidal activity of chemical disinfectants and antiseptics in the veterinary area – Test method and requirements (phase 2, step 2). The standard defines a test method and minimum requirements for evaluating the mycobactericidal activity of chemical disinfectants and antiseptics, ensuring that they are homogeneous and physically stable when diluted in hard water or, for ready-to-use products, in water. It applies to products used in the veterinary field on non-porous surfaces without mechanical action, including animal breeding, production, transport and disposal premises.
• EN 16437 Chemical disinfectants and antiseptics – Quantitative surface test for the evaluation of the bactericidal activity of chemical disinfectants and antiseptics, used in the veterinary field on porous surfaces without the support of mechanical action – Test method and requirements (phase 2, stage 2). The standard defines a test method and minimum requirements for evaluating the bactericidal activity of chemical disinfectants and antiseptics, ensuring that they are homogeneous and physically stable when diluted with hard water or, for ready-to-use products, with water. It applies to products intended for veterinary use on porous surfaces without mechanical action, including livestock farming, agriculture, production, transport and disposal of animals.
• EN 17387 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the bactericidal activity of chemical disinfectants in medical areas, on non- porous surfaces without mechanical action – Test method and requirements (phase 2, stage 2). The standard defines a test method and minimum requirements for evaluating the bactericidal, levuricide and fungicidal activity of chemical disinfectants, ensuring that they are homogeneous and physically stable when diluted in hard water or, for ready-to- use products, in water. It applies to products used in the medical field for the disinfection of non-porous surfaces without mechanical action, in areas where disinfection or antisepsis is medically prescribed, such as hospitals, medical facilities, dental surgeries, school clinics, nurseries, workplaces or homes.
• AFNOR NF T 72-110 Methods of surface disinfection by steam with or without contact – Determination of bactericidal, fungicidal, levuricide, sporicidal and virucidal activity, including bacteriophages. This document describes a method for determining the disinfectant activity of steam surface disinfection devices (SDDs) used in the healthcare, veterinary, food, industrial and community sectors.

Mycobactericidal efficacy test

• EN 14348 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the mycobactericidal activity of chemical disinfectants in the medical field, including instrument disinfectants – Test methods and requirements (phase 2, stage 1). The standard defines a test method and minimum requirements for evaluating the mycobactericidal (or tuberculocidal) activity of chemical disinfectants, ensuring that they are homogeneous and physically stable when diluted with hard water or, for ready-to-use products, with water. Products may only be tested at concentrations equal to or lower than 80%.
• EN 14563 Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of the mycobactericidal and tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, stage 2). The standard establishes a test method and minimum requirements for evaluating the mycobactericidal and tuberculocidal activity of chemical disinfectants, ensuring that they are homogeneous and physically stable when diluted with hard water or, for ready-to-use products, with water.
• EN 14204 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the mycobactericidal activity of chemical disinfectants and antiseptics in the veterinary area – Test method and requirements (phase 2, step 1). The standard establishes a test method and minimum requirements for evaluating the mycobactericidal activity of chemical disinfectants and antiseptics, ensuring that they are homogeneous and physically stable when diluted with hard water or, for ready-to-use products, with water. Products may only be tested at concentrations of 80% or less, as the addition of microorganisms and interfering substances causes dilution. It applies to products intended for use in the veterinary field, such as breeding, production, transport and disposal environments of animals.

Fungicide or levuricide efficacy test

• EN 1657 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the fungicidal or levuricide activity of chemical disinfectants and antiseptics in veterinary pplications – Test method and requirements (phase 2, step 1). The standard establishes a test method and minimum requirements for evaluating the fungicidal or levuricide activity of chemical disinfectants and antiseptics, ensuring that they are stable and physically homogeneous when diluted in hard water or, for ready-to-use products, in water. It applies to products used in veterinary applications, such as animal housing, breeding, transport, slaughter and disposal environments.
• EN 1650 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the fungicidal or levuricide activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional applications – Test method and requirements (phase 2, step 1). The standard defines a test method and minimum requirements for the fungicidal or levuricide activity of chemical disinfectants and antiseptics, testable at concentrations equal to or less than 80%. It applies to products for food, industrial, domestic and institutional use, excluding medical contexts and use on living tissue, except for hand hygiene.
• EN 13697 Chemical disinfectants and antiseptics – Quantitative test on non-porous surfaces for the evaluation of the levuricide and/or fungicidal activity of chemical disinfectants used in the food, ndustrial, domestic and institutional sectors, without mechanical action – Test method and requirements without mechanical action (phase 2, stage 2). The standard defines a test method (phase 2, stage 2) and minimum requirements for evaluating the bactericidal, fungicidal or levuricide activity of homogeneous and stable chemical disinfectants and antiseptics, diluted in hard water or, for ready-to-use products, in water. It applies to the disinfection of non-porous surfaces without mechanical action in food, industrial, domestic and institutional sectors, excluding medical contexts and use on living tissue.
• EN 13624 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal or levuricide activity in the medical field – Test method and requirements (phase 2, stage 1). The standard establishes a test method and minimum requirements for evaluating the fungicidal or levuricide activity of stable and homogeneous chemical disinfectants and antiseptics diluted in hard water or, for ready-to-use products, in water. Products can be tested at concentrations equal to or lower than 80% (or 97% in special cases with a modified method). It applies to products used in the medical field for hand hygiene, disinfection of medical instruments by immersion and disinfection of surfaces by rubbing, spraying or other methods. The standard refers to contexts where disinfection is medically indicated, such as hospitals, clinics, dental clinics, schools, kindergartens, nursing homes, workplaces and homes, also including services such as laundries and kitchens that supply products to patients.
• EN 1275 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the basic fungicidal or basic fermentative activity of chemical disinfectants and antiseptics – Test and requirements (Phase 1). The standard specifies a test method and minimum requirements for the basic fungicidal or basic fermentative activity of chemical disinfectant and antiseptic products that form a physically stable, homogeneous preparation when diluted with water.
• EN 17387 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the levuricide and/or fungicidal activity of chemical disinfectants in medical areas, on non-porous surfaces without mechanical action – Test method and requirements (phase 2, stage 2). The standard defines a test method and minimum requirements for evaluating the bactericidal, levuricide and fungicidal activity of chemical disinfectants, ensuring that they are homogeneous and physically stable when diluted in hard water or, for ready-to-use products, in water. It applies to the disinfection of non-porous surfaces without mechanical action in medical areas, where disinfection or antisepsis is medically envisaged, such as hospitals, medical facilities, dental clinics, schools, nurseries, workplaces and homes. It also includes services such as laundries and kitchens that supply products to patients. EN 14885 describes the correlation between the tests. This method, phase 2, stage 2, allows the evaluation of commercial formulations or active ingredients against bacteria and fungi, but excludes mycobacteria and bacterial spores.
• EN 14562 Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or fermentative activity for instruments used in the medical area – Test method and requirements (phase 2, stage 2). The standard specifies a test method and minimum requirements for the fungicidal and fermentative activity of chemical disinfectant products that form a physically stable homogeneous preparation when diluted with hard water or, in the case of ready-to-use products, with water.
• EN 16438 Chemical disinfectants and antiseptics – Quantitative surface test for the evaluation of fungicidal or levuricide activity of chemical disinfectants and antiseptics in the veterinary area on non-porous surfaces without mechanical action – Test method and requirements (phase 2, stage 2). The standard specifies a test method and minimum requirements for the fungicidal or levuricide activity of chemical disinfectant and antiseptic products that form a homogeneous preparation that is physically stable in hard water or – in the case of ready-to-use products – in water.

Sporicidal efficacy test

• EN 14347 Chemical disinfectants and antiseptics – Basic sporicidal activity – Test method and requirements (phase 1, step 1). The standard specifies a test method (phase 1) and minimum requirements for the sporicidal activity of chemical disinfectants and antiseptics that form a homogeneous preparation, physically stable when diluted with water.
• EN 17126 Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of the sporicidal activity of chemical disinfectants in the medical field – Test method and requirements (phase 2, step 2). The standard establishes a test method and minimum requirements for evaluating the virucidal activity of chemical disinfectants, ensuring that they are homogeneous and physically stable when diluted with hard water or, for ready-to-use products, in water. It applies to products used in medical settings to disinfect instruments (by immersion) and surfaces by wiping, spraying or other methods, in settings where disinfection is medically indicated, such as hospitals, medical facilities, dental clinics, schools, daycare centers, workplaces and homes. It also includes services that provide products to patients, such as laundries and kitchens.

Virucidal efficacy tests

Other specific efficacy tests can be performed or customized depending on the product/application considered.

* PT: Product-type

• PT 1: Product-type 1: Biocidal products for human hygiene
• PT 2: Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals
• PT 3: Product-type 3: Biocidal products for veterinary hygiene
• PT 4: Product-type 4: Disinfectants for food and feed
• PT 5: Product-type 5: Disinfectants for drinking water
• PT 18: Product-type 18: Insecticides, acaricides and products for the control of other arthropods
• PT 19: Product-type 19: Repellents and attractants