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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 used to generate efficacy data to claim the registration of sporicidal disinfectants in medical areas. Disinfectant products that come within scope of EN 17126 standard include immersion disinfectants and surface disinfectants like wipes, sprays, and cleansers.
EN 17126 specifies a quantitative suspension (phase 2, step 1) test that provides a quantitative measure of product efficacy against obligatory bacterial spores strains.
EN 17126 Test Conditions & Requirement
EN 17126 (phase 2 step 1) | Surface disinfection | Instrument disinfection
| Textile disinfection |
Mandatory test microorganisms | Bacillus subtilis Bacillus cereus Clostridium difficile | Bacillus subtilis Bacillus cereus Clostridium difficile | Bacillus subtilis Bacillus cereus Clostridium difficile
|
Additional | Any relevant strain | ||
Test temperature | According to the manufacturer’s recommendation, but at/between | ||
4 °C and 30 °C | 20 °C and 70 °C | 20 °C and 80 °C | |
Contact time | According to the manufacturer’s recommendation , but no longer than | ||
15 or 60 min | 60 min | 60 min | |
Interfering substance – Clean conditions | 0.3 g/l bovine albumin solution | 0.3 g/l bovine albumin solution | 0.3 g/l bovine albumin solution |
Dirty conditions | 3.0 g/l bovine albumin solution plus 3.0 ml/l erythrocytes | 3.0 g/l bovine albumin solution plus 3.0 ml/l erythrocytes | 3.0 g/l bovine albumin solution plus 3.0 ml/l erythrocytes |
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 (table 1).
- 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 indispensable in hospitals and other important health settings to destroy pathogens and reduce the risk of cross contamination. However, spore forming bacterial species like Bacillus and Clostridium show resistance to standard disinfectants. This in turn presents a complex challenge for infection control in health care settings.
- For effective protection against bacterial spores and their associated health hazards, it is crucial to use disinfectants which have sporicidal properties. Hence, sporicidal efficacy is performed to ensure that the finished product meets requirements for sterility and infection control.
- As per European guidelines, EN 17126 specifies test procedures to determine sporicidal activity of products that are planned to be used for disinfection purposes in medical areas.
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.
FAQs
EN 17126 test is a quantitative suspension test (phase 2, step 1) for disinfectants used in medical areas. During EN 17126, disinfectant samples are added to microbes of interest and interfering substances for specific contact times. 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, we test for EN 17126 using the following microbial strains: Bacillus subtilis, Bacillus cereus, and Clostridium difficile.
Contact us for more information
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