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)

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Quick understanding of the test

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 evaluates the bactericidal, yeasticidal, and fungicidal efficacy of chemical disinfectants used in medical areas on hard, non-porous surfaces without mechanical action.

Application

Applicable to chemical surface disinfectant products.
Test microorganisms are inoculated onto a stainless steel surface and dried. The disinfectant is applied for a specific contact time. After neutralization, the neutralized solution is plated and incubated to enumerate viable microorganisms.

Turnaround Time

  • Bactericidal tests: 2–3 weeks.
  • Yeasticidal/Fungicidal tests: 4–5 weeks.
The reduction in viable microbial counts between the sample and the control is determined to assess the product’s efficacy.

Passing criteria

Minimum 5-log reduction for bacteria and 4-log reduction for fungi.

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Abstract

EN 17387 is a quantitative carrier test for chemical disinfectants used in medical areas and similar other situations where disinfection is medically indicated. In the 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 substances is inoculated onto a stainless steel surface and allowed to dry.
  • The 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, the test surface is kept for specific contact times to allow the interaction between the 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 a 5-log reduction for bacteria and a 4-log reduction 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.

Conclusion

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.

Frequently Asked Questions

DR. Martinoz Scholtz

MIS Labs
1. What is EN 17387 test?

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.

2. What are the Products that can be tested with EN 17387 test?

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.

3. What is the Turnaround Time for EN 17387 test?

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.

4. On how many microbial strains can your EN 17387 testing lab perform tests on?

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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