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EN 1650: 2019
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EN 1650: 2019 – Quantitative Suspension Test for the Evaluation of Fungicidal or Yeasticidal Activity of Chemical Disinfectants and Antiseptics
Application
- Candida albicans
- Aspergillus brasiliensis
- Disinfectant is diluted to the recommended concentration.
- Diluted disinfectant is mixed with specific test organisms.
- Mixture is incubated for a defined contact time.
- Disinfectant is neutralized using a neutralizing solution.
- Remaining viable organisms in neutralizing solution are quantified using the plate count method.
- Aids in formulating effective and compliant disinfectants.
- Assists in meeting European regulatory requirements
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Abstract
BS EN 1650 is a European standard that describes a quantitative suspension test for the evaluation of the fungicidal or yeasticidal activity of chemical disinfectants and antiseptics. It is a phase 2 step 1 suspension test. The test standard is applicable to general-purpose disinfectants and hand hygiene products used in various areas, including food, industrial, domestic, and institutional. It ensures the efficiency of disinfectants and antiseptics against fungi and yeasts under certain conditions, making it an important guideline for manufacturers and users of these products.
EN 1650 test conditions & requirements
To ensure that the results obtained from testing are accurate and reproducible, the standard specifies strict test conditions and requirements that must be followed. The test conditions and requirements include:
- Test organisms: Test organisms include Candida albicans and Aspergillus brasiliensis. Other organisms may be chosen depending on the specific application for which the disinfectant is required.
- Test temperature: The test is conducted at temperatures between 4°C and 40°C.
- Contact time: Contact time varies between 1 minute and 60 minutes in accordance with the specific application and the manufacturer’s instructions.
- Interfering substance: Interfering substances are used to simulate practical use conditions. These include clean conditions with 0.3 g/L bovine albumin and dirty conditions with 3.0 g/L bovine albumin.
EN 1650 test method – fungicidal suspension test for disinfectants
- Preparation: The disinfectant is diluted to the manufacturer’s recommended use concentration. A suspension of the target test organisms is added to the disinfectant containing an interfering substance in order to simulate real-use conditions.
- Incubation: The mixture is incubated at the desired test temperature for the contact time specified by the manufacturer.
- Neutralization: An aliquot of the solution is removed after the contact time and neutralized to stop the action of the disinfectant. Neutrationzation is done via dilution-neutralization or membrane filtration.
- Analysis: The number of surviving organisms is measured by the plate count method and then calculated to determine the reduction in the viable organisms number.
Log reduction
A disinfectant or antiseptic has to achieve a 4-log reduction, equivalent to a 99.99% reduction in the viable fungal or yeast cells, to pass the test. This criterion, therefore, will ensure that the product offered has strong antifungal and anti-yeast properties.
Importance of EN 1650 standard
The standard plays an important role in ensuring the effectiveness of disinfectant products against fungi and yeasts. This is of significant importance in areas such as domestic, industrial, and food processing units where maintaining clean, hygienic conditions is crucial. The test helps guarantee that the products meet the necessary industrial standards, thus contributing to the well-being of public health.
Compliance and industry standard
EN 1650 is an international standard in testing the antifungal efficacy of disinfectant products. Compliance with this standard provides manufacturers an assurance of their product’s effectiveness. By testing their products, manufacturers can increase their chances of getting product approval. The test reports help streamline the process of product registration, regulatory approval, and certification. Compliance also opens the door to international product sales as the standard is widely accepted across the world.
Benefits of EN 1650 test standard
Some benefits of performing this test include:
1.Validated efficacy
The test provides validated data regarding the fungicidal and yeasticidal efficacy of disinfectants, assuring manufacturers that their products work as expected.
2. Regulatory approval
Compliance is often a requirement for regulatory approval in many regions, thus making it essential for manufacturers who aim to market their products internationally.
3. Product improvement
The results of the test can help manufacturer identify areas in which their disinfectants might need improvement, thus enabling the optimization of product formulation to perform better.
4. Enhanced safety
Tested products can be trusted to reduce the risks of fungal contamination, thus contributing to improved safety in industrial, food, and other environments.
Why choose MIS for EN 1650 testing
At Microbe Investigations Switzerland (MIS), we offer EN 1650 testing services to help manufacturers assess the fungicidal and yeasticidal efficacy of their chemical disinfectants and antiseptics. Our team of experts is dedicated to providing reliable, accurate testing in compliance with international standards, ensuring that your products meet regulatory requirements and perform effectively in real-world applications.
With state-of-the-art laboratory facilities and extensive expertise in microbiological testing, MIS is committed to delivering high-quality antimicrobial testing services that help you achieve your product development and regulatory goals. Partner with us to ensure your disinfectants meet the stringent requirements of industry standards and provide the efficacy that your customers expect.
We also perform EN 14476 test for disinfectants to assess their virucidal activity against a range of viral strains.
Contact us today to learn more about our testing services or to schedule your EN 1650 test.
Frequently Asked Questions
DR. Martinoz Scholtz
The test is used to evaluate the efficacy of chemical disinfectants and antiseptics that claim to possess fungicidal or yeasticidal action.
The test is applicable to disinfectants/chemical antiseptics used in food, industrial, domestic, and institutional areas.
The test takes 2-3 weeks to complete.
At Microbe Investigations Switzerland, we perform the test using Candida albicans (MTCC 3017), Aspergillus brasiliensis, Aspergillus niger (ATCC-16888). Additional strains can be tested at the customer’s request.
The test is crucial because it provides a reliable method to assess the fungicidal and yeasticidal activity of disinfectants.
Disinfectant and hand hygiene product manufacturers whose products are used in various sectors such as industrial, food processing, domestic, etc are required to perform this test to ensure that their products are effective against fungi and/or yeast.
A product must achieve at least a 4-log reduction, which translates to a 99.99% reduction in the viability of test organisms to pass the test.
No, the test specifically focuses on the fungicidal and yeasticidal activity of liquid disinfectants and antiseptics. Other standards are available to test the efficacy of air disinfectants.
The test is a laboratory test performed under controlled environmental conditions thus it may not address all practical scenarios where disinfectants are used.
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