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BS EN 13624:2021
Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the medical area (phase 2, step 1)
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Quick understanding about test
BS EN 13624:2021 - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the medical area
- Candida albicans (MTCC 3017)
- Aspergillus brasiliensis (ATCC 16888)
- The test involves preparing a test suspension with interfering substances, mixing it with the product under specific conditions, and allowing it to act for a defined contact time. After neutralizing the sample, an aliquot is plated and incubated. Viable cells are then counted to determine efficacy.
- Ensures efficacy of disinfectants used in medical areas.
- Customizable testing for additional strains based on client requirements.
The product must achieve a minimum 4-log reduction in the microbial count.
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Abstract
EN 13624 specifies a test method to assess the fungicidal or yeasticidal efficacy of antiseptics and disinfectant products intended for use in medical areas.
EN 13624 standard is applicable to areas or situations where disinfection is medically indicated. EN 13624 test can be performed for these given products –
- Hygienic handrub and handwash
- Surgical hand rub and handwash
- Instrument disinfectants
- Surface disinfectants like sprays, wipes, and more
EN 13624 test conditions and requirements
Test Conditions | Hygienic handrub and handwash | Surgical handrub and handwash | Instrument disinfection | Surface disinfection |
Mandatory test organisms | Candida albicans (MTCC 3017) | Candida albicans (MTCC 3017) | Fungicidal activity Aspergillus brasiliensis (ATCC-16888) Yeasticidal activity Candida albicans (MTCC 3017) | Fungicidal activity Aspergillus brasiliensis (ATCC-16888) Yeasticidal activity Candida albicans (MTCC 3017) |
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 | |||
30s and 60s |
1 min and 5 min |
60 min |
5 min or 60 min | |
Interfering substance – clean conditions | 0.3 g/l bovine albumin solution (hygienic hand rub) | 0.3 g/l bovine albumin solution (surgical hand rub) | 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 | ≥ 4.0 for hand rub ≥ 2.0 for hygienic hand wash | ≥ 4.0 | ≥ 4.0 | ≥ 4.0 |
EN 13624 Test Method
- Interfering substance and test suspension are taken into a test tube.
- Sample product is added into the same test tube and held for specific contact period times.
- At the end of contact time, an aliquot of solution is acquired from test tube and is transferred into a test tube containing neutralizing solution.
- 1 ml of neutralizing extract is plated and incubated for 48 hrs.
- After inoculation, viable cells are counted, and results are compared to the control sample.
- To pass EN 13624, the product must achieve a 4-log reduction value.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 13624 test is performed to determine the fungicidal or yeasticidal activity of products intended for disinfection in medical areas.
Products to be tested using EN 13624 include hygienic hand rub, hygienic handwash, surgical hand rub, surgical handwash, instrument disinfectants, and surface disinfectants.
EN 13624 test takes 2-3 weeks to complete.
At Microbe Investigations, we test for EN 13624 using the following strains: Aspergillus brasiliensis (ATCC-16888) and Candida albicans (MTCC 3017). Additional strains can be added at the customer’s request.
If you are looking for testing services for EN 13624 standard, MIS team experts would be happy to serve you. We are a team of highly experienced professionals who render efficacy testing services in accordance with international standards while understanding customer needs.
With the help of our highly upgraded and well-equipped testing facility, we are able to execute and deliver accurate results to our clients.
From our fungicidal or yeasticidal assessment portfolio, customers can also select and send their product samples for tests like EN 1650 and EN 1657.
For more questions about our antifungal testing services, contact our experts here and get expert consultation.
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