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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
EN 13624 is a phase 2 step 1 quantitative suspension test to determine the fungicidal or yeasticidal efficacy of antiseptics and disinfectants used in medical areas.
- 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 is a Phase 2 step 1 quantitative suspension test that evaluates the fungicidal and yeasticidal activity of chemical disinfectants and antiseptics intended for use in the medical areas. It simulates real-world application conditions, providing robust data on the efficacy of formulations claiming the efficacy against fungi and yeasts such as Candida albicans and Aspergillus brasiliensis under both clean and dirty conditions.
The standard specifies the use of conidiospores of Aspergillus brasiliensis (formerly A. niger) together with vegetative cells of Candida albicans to assess fungicidal activity, and only the vegetative cells of C. albicans for testing yeasticidal activity.
Scope of application
EN 13624 standard is applicable to areas or situations where disinfection is medically indicated. This test can be performed for the 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
Note:
- Products that are intended to disinfect surfaces which are likely to come in contact with patient/ medical staff and surfaces (high-touch surfaces) must be tested with a contact time of maximum 5 minutes. All other surfaces may be tested with a contact time of up to 60 minutes.
- Hygienic and surgical handrubs must be tested under clean conditions as a minimum requirement.
- Hygienic and surgical handwash must be tested under dirty conditions as a minimum requirement.
EN 13624 Test Method
- Interfering substance and test suspension are added into a test tube, followed by the addition of sample products.
- 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.
Importance of EN 13624 Test
Candida albicans and Aspergillus brasiliensis are well-known fungal pathogens that pose serious health risks, especially in medical settings where patients are more vulnerable. Disinfection plays a crucial role in preventing the spread of these organisms but only when the right products are used. This is where EN 13624 becomes essential. It defines the criteria for evaluating whether a disinfectant truly has fungicidal or yeasticidal activity. This standard ensures that products claiming to kill fungi are both reliable and effective. As a result, EN 13624 helps healthcare providers make informed choices, supporting infection control with scientifically validated disinfectants.
Additionally, meeting the EN 13624 standard facilitates smoother market access across Europe, as it aligns with the harmonized testing framework established by the European Committee for Standardization (CEN).
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.
Frequently Asked Questions
DR. Martinoz Scholtz
EN 13624 is a Phase 2 step 1 quantitative suspension test that evaluates the fungicidal and yeasticidal activity of chemical disinfectants and antiseptics intended for use in the 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 Switzerland, 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 customerโs request.
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