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BS EN 13727:2012
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Quick understanding about test
BS EN 13727:2012 - Evaluation of bactericidal activity of chemical disinfectants used in the medical area (phase 2, step 1)
Application
- Pseudomonas aeruginosa (ATCC 15442)
- Staphylococcus aureus (ATCC 6538P)
- Enterococcus hirae (ATCC 10541)
- Escherichia coli (K12)
- The test involves exposing the disinfectant sample to a bacterial suspension under specified conditions for a set contact time.
- After neutralization, the mixture is incubated, and viable colonies are counted to determine the product’s efficacy.
Benefits
- Validates the bactericidal claims under practical conditions.
- Ensures compliance with industry and regulatory standards.
Turnaround Time
The test typically takes 1–2 weeks to complete.
The bactericidal activity of the disinfectant products is determined by comparing the reduction in the viable colonies with the original culture size.
Passing criteria
- ≥5 log reduction for hand rubs, surgical hand rubs, and disinfectants.
- ≥3 log reduction for hygienic handwash.
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Abstract
EN 13727 is a quantitative suspension test that determines the bactericidal activity of chemical disinfectants used in the medical area. The common areas where disinfection is medically indicated include patient care settings, nursing homes, dental facilities, clinics of schools, etc.
EN 13727 test ensures that the given disinfectant formulation should be effective against a range of pathogenic bacteria to meet its bactericidal efficacy claims under practical applications.
This test is applicable to a myriad of commercial products that are used in medical care facilities for disinfection –
- Hygienic handrub,
- hygienic handwash,
- surgical handrub,
- surgical handwash,
- instrument disinfectants
- and surface disinfectants.
EN 13727 Test Conditions & Requirements
Test Conditions | Hygienic handrub and handwash | Surgical handrub and handwash | Instrument disinfection | Surface disinfection |
Mandatory test organisms | Pseudomonas aeruginosa (ATCC 15442) Staphylococcus aureus (ATCC 6538P) Enterococcus hirae (ATCC 10541) E. coli (K 12) | Pseudomonas aeruginosa (ATCC 15442) Staphylococcus aureus (ATCC 6538P) Enterococcus hirae (ATCC 10541) E. coli (K 12) | Pseudomonas aeruginosa (ATCC 15442) Staphylococcus aureus (ATCC 6538P) Enterococcus hirae (ATCC 10541) when temperature is 40 °C or higher: only E. faecium
| Pseudomonas aeruginosa (ATCC 15442) Staphylococcus aureus (ATCC 6538P) Enterococcus hirae (ATCC 10541) |
Additional | Any relevant test organism | |||
Test temperature | According to the manufacturer’s recommendation, but at/between | |||
20 °C and 20 °C | 20 °C and 20 °C | 20 °C and 70 °C | 4°C and 30 °C | |
Contact time | According to the manufacturer’s recommendation | |||
but between | But no longer than | |||
30 s and 60 s | 1 min and 5 min | 60 min | 5 min or 60 min | |
Interfering substance clean conditions | 0,3 g/l bovine albumin solution (hygienic handrub) | 0,3 g/l bovine albumin solution (surgical handrub) | 0,3 g/l bovine albumin solution | 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes |
Interfering substance – dirty conditions | 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (hygienic handwash) | 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (surgical handwash) | 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 |
Log reduction | ≥ 5 for handrub ≥ 3 for hygienic hand wash | ≥ 5 | ≥ 5 | ≥ 5 |
EN 13727 Test Method
- Test sample is exposed to bacterial suspension in the presence of an interfering substance.
- Mixture is maintained at specific contact period time and under other mandatory conditions
- After the end of contact period, 1 ml of mixture is neutralized.
- Neutralizing extract is incubated for 2 days and viable colonies are enumerated.
- Reduction in viable colonies is compared with original culture size.
Conclusion
MIS has introduced a comprehensive range of microbiology efficacy testing for chemical disinfectants and antiseptics claiming bactericidal properties. In addition to EN 13727, we are also capable of doing disinfectant efficacy testing using EN 13697.
In antiviral efficacy testing of chemical disinfectants and antiseptics, EN 14476 is a very frequently performed test method in our laboratory.
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Frequently Asked Questions
DR. Martinoz Scholtz
EN 13727 standard evaluates bactericidal activity of chemical disinfectant and antiseptic products used in medical area.
Products that can be tested with EN 13727 test include hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument, and surface disinfectant formulations.
EN 13727 test takes 1-2 weeks to complete.
At Microbe Investigations, we test for EN 13727 using the following bacterial and fungal strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica (ATCC 10708), Aspergillus niger (ATCC-16888), Candida albicans (MTCC 3017).
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