EN 17387
Determine Bactericidal, Yeasticidal or Fungicidal activity of Chemical Disinfectant
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BS EN 17387:2021 – Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action (phase 2 step 2)
EN 17387 is a quantitative carrier test for chemical disinfectants used in medical areas and similar other situations where disinfection is medically indicated. In test procedure, disinfectant product samples are challenged with obligatory microorganisms on a non-porous surface without mechanical action.
EN 17387 test determines whether a chemical disinfectant has bactericidal, yeasticidal or fungicidal action with regard to specific conditions of its intended use.
EN 17387 Test Conditions & Requirement
EN 17387 (phase 2 step 2) | Bactericidal activity | Yeasticidal activity | Fungicidal activity |
Mandatory test microorganisms | Staphylococcus aureus (ATCC 6538P) Enterococcus hirae (ATCC 10541) Pseudomonas aeruginosa (ATCC 15442) | Candida Albicans (MTCC 3017) | Aspergillus niger (ATCC-16888) Candida Albicans (MTCC 3017) |
Additional | Any relevant strain | ||
Test temperature | According to the manufacturer’s recommendation, but between (4 ± 1) °C to (30 ± 1) °C For tests performed at room temperature, the range shall be (21.5 ± 3.5) °C | ||
Contact time | according to the manufacturer’s recommendation, but at minimum 1 min and no longer than 5 min or 60 min (from 1 min to 5 min at intervals of 1 min and from 5 min to 60 min at intervals of 5 min) | ||
Interfering substance clean conditions | 3.0 g/l bovine albumin | ||
Interfering substance dirty conditions | 3.0 g/l bovine albumin plus 3.0 ml/l erythrocytes | ||
Additional | Any relevant substance | ||
EN 17387 Test Method
- A test suspension of microorganisms with interfering substance is inoculated onto a stainless steel surface and allowed to dry.
- Disinfectant product sample is applied thoroughly on dried microbial film. In parallel, a control test is run wherein hard water is applied to the stainless steel surface with dried inoculum.
- In the next step, test surface is kept for specific contact times to allow the interaction between test sample and challenge microorganisms.
- After contact time, the test surface is neutralized using a neutralizing solution to halt further activity of the product sample.
- Neutralizing extract is plated and incubated to check if any viable microorganisms are present. This is followed by enumeration of bacterial colonies on treated samples and control samples.
- To pass EN 17387 test, product samples must be able to achieve 4 log reduction for bacteria and 5 log reduction value for fungi respectively.
Importance of EN 17387 Test
Surface disinfectants which are planned to be used in medical areas require approval from regulatory authorities. In general, the regulatory basics for chemical disinfectants are different in different countries. In Europe, EN standards are available to validate the efficacy of disinfectants before their market release. Technically, these standards specify all test parameters based on practical use of products.
EN 17387 provides test protocols, practical conditions of product usage, and interfering substances for evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants used in the medical area.
MIS offers antimicrobial (bacteria, viruses, fungi/yeast) analysis of disinfectants and antiseptics to assist clients in generating data reports for product efficacy. Our labs are well equipped with advanced technology and automated systems to assure accuracy and precision at each and every step of the analysis process.
Furthermore, our microbiology experts provide all technical guidance on choosing the right standards based on disinfectant chemistry. For disinfectant testing, we craft test protocols in adherence to different country standards including EN, AOAC, ASTM, and EPA.
To learn more about EN 17387 test and our disinfectant efficacy testing services, reach out to us today.
FAQs
EN 17387 is a phase 2 step quantitative carrier test for bactericidal, yeasticidal and fungicidal disinfectants. This test is implied for chemical disinfectants used in medical areas/situations to destroy or kill pathogens on hard non – porous surfaces without mechanical action.
EN 17387 test is applicable for chemical surface disinfectant products which have microbicidal action against bacteria, viruses, and fungi. This includes conditions where disinfection is medically necessary such as hospital settings, dental institutions, schools, kindergartens, nursing homes, and laundries and kitchen areas providing services to patients.
EN 17387 test for bacteria typically takes 2-3 weeks to complete. Whereas, turnaround time for antiviral and antifungal samples is around 4-5 weeks.
At Microbe Investigations, we test for EN 17387 using the following microbial strains: Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Pseudomonas aeruginosa (ATCC 15442), Aspergillus niger (ATCC-16888) and Candida Albicans (MTCC 3017)
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