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EN 17126
Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area (phase 2, step 1)
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Evaluation of Sporicidal Activity of Disinfectants
Quantitative test for sporicidal efficacy testing of disinfectants used in food, industrial, domestic and institutional areas
Quick understanding of the test
BS EN 17126:2018 - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area (phase 2, step 1)
EN 17126 is a quantitative suspension (phase 2, step 1) test that evaluates the efficacy of sporicidal disinfectants used in medical areas.
Applicable to immersion disinfectants and surface disinfectants, such as wipes, sprays, and cleansers, used in healthcare settings.
- Bacillus subtilis
- Bacillus cereus
- Clostridium difficile
- The test sample is exposed to a suspension of test microbes and interfering substance.
- The test mixture is incubated for a specific contact time.
- At the end of the contact time, the test mixture is neutralized, and the neutralizing solution is plated and incubated to quantify the viable microorganisms.
- This standard ensures that the disinfectants used in medical settings are effective against bacterial spores, which are among the most challenging organisms to eradicate.
- By providing a clear benchmark for sporicidal effectiveness, EN 17126 aids in the development and improvement of disinfectants.
Turnaround Time
Typically, the test takes 2-3 weeks to complete.
The test determines the sporicidal activity of disinfectants by quantifying the log10 reduction in bacterial spores.
Passing criteria
The disinfectant must achieve at least a 4-log reduction in bacterial spores to meet EN 17126 requirements.
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Abstract
EN 17126 is a European standard that outlines a quantitative suspension test (phase 2, step 1) test to determine the sporicidal activity of chemical disinfectants and antiseptics used in medical environments. Bacterial spores are highly resistant to ordinary disinfectants. Thus, to eliminate these resilient pathogens, it is necessary to use disinfectant products that specifically claim sporicidal actions. EN 17216 helps validate these claims by providing a standardized method for testing a productโs sporicidal action.
Scope of products for testing
The standard applies to disinfectant products that are intended for use in medical areas like
- Hospitals,
- Clinics of schools, kindergartens,
- Nursing homes,
- Community medical facilities,
- Dental institutions and more.
The product types include disinfectants used for:
- Instrument disinfection by immersion
- Surface disinfection by wiping, spraying, or flooding
- Textile disinfection
EN 17126 Test Conditions & Requirements
EN 17126 Test Method
- Test product is challenged with the suspension of the test organism and interfering substance.
- The test mixture is incubated at the defined temperature for a specific contact period as per the test requirements.
- At the end of the contact time, the reaction between the test product and challenged organism is terminated by a neutralizing solution.
- Plating method is used to quantify the viable microorganisms recovered from the neutralizing medium.
- To pass EN 17126, test product must show at least 4 log reduction values against mandatory test microorganisms.
Importance of EN 17126 Test
Disinfectant products are essential in hospitals and other critical healthcare environments to destroy pathogens and minimise the risk of cross-contamination. However, spore-forming bacterial species such as Bacillus and Clostridium are notoriously resistant to standard disinfectants. Their robust protective coatings allow them to survive harsh environmental conditions and persist on surfaces, instruments, and textiles for extended periods, potentially causing severe infections and outbreaks, especially in vulnerable healthcare settings.
To ensure reliable protection against bacterial spores and their associated health hazards, it is vital to use disinfectants with proven sporicidal properties. EN 17126 outlines the test method to determine if a disinfectant is capable of inactivating bacterial spores under practical conditions, thereby verifying that the product can achieve the high level of sporicidal efficacy needed to meet strict hygiene and sterility requirements.
MIS provides extensive services for testing disinfectants that are designed to be used in medical, domestic, institutional, and veterinary areas. Our microbiology testing portfolio comprises antibacterial, sporicidal, antifungal/yeasticidal and virucidal test methods which are in compliance with international standards and guidelines.
With the help of our qualified staff and advanced laboratory set up, we ensure to provide accurate, satisfactory, and timely services to our clients.
For sporicidal disinfectant products, EN 13704 test is another most frequently requested and performed test method at MIS.
To request EN 17126 testing, talk to our experts here and get thorough consultation.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 17126 test is a quantitative suspension test (phase 2, step 1) for disinfectants used in medical areas. During EN 17126 testing, disinfectant samples are challenged with added to microbes of interest and interfering substances for specific contact times. The tested sample is considered to be effective only if it can achieve 4 log reduction of bacterial spores.
EN 17126 test is applicable to products used for instruments and hard surface disinfection in medical facilities. Product types mainly include immersion disinfectants and surface disinfectants like wipes, sprays, and cleansers.
EN 17126 test takes 2-3 weeks to complete.
At Microbe Investigations Switzerland, we test for EN 17126 using the following microbial strains: Bacillus subtilis, Bacillus cereus, and Clostridium difficile.
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