EN 1275 is the European Standard that specifies the requirements and test methods to assess the basic fungicidal and yeasticidal activities of chemical disinfectants and antiseptics. Testing according to EN 1275 ensures compliance, effectiveness, and safety. This guide covers scope, key requirements, test methods, and implications for various industries.
Scope and Application
EN 1275 applies to products intended to be used in the healthcare sector, veterinary applications, food production, domestic, and industrial areas. It lays down the requirements for assessing the efficacy of disinfectants and antiseptics against fungi and yeasts.
Key Requirements of EN 1275
Test Organisms
EN 1275 recommends to use two representative test organisms: Candida albicans and Aspergillus brasiliensis. These microorganisms are used since they represent fungi and yeasts of different origins.
Test Conditions
The standard details the conditions under which the tests shall be performed, including temperature, contact time, and disinfectant concentration. The tests shall be performed at a temperature of 20°C ± 1°C with contact times between 5 to 60 minutes. These conditions are meant to imitate situations occurring in real-life scenarios to ensure reliability in test results.
Methodology of EN 1275
- Product samples are challenged with compulsory test strains. After mixing, the mixture is then incubated for some specified contact period.
- After contact time, the test mixture is neutralized to stop the action of the disinfectant. This step ensures that the subsequent steps accurately reflect the efficacy of the product during the incubation period.
- The neutralized mixture is then plated on appropriate agar media to allow any surviving fungi and yeast to grow.
- The plated samples are incubated for a specified time to allow colonies to develop.
- After incubation, the number of colonies is counted. The reduction in the number of viable organisms compared to the control sample indicates the efficacy of the product.
Passing Criteria
According to EN 1275, the product should achieve a considerable reduction in the number of viable fungi and yeast. By ‘considerable reduction’, this means obtaining at least a 4-log reduction, which is equivalent to a 99.99% reduction in viable organisms. Only those products that show such efficacy will have their use approved.
The Importance of EN 1275
Ensuring Product Efficacy
EN 1275 is applied as a preliminary test to screen the basic efficacy of a product against fungi and yeasts. Products must pass this test in order for other phases of testing to happen if more stringent conditions are required in that case; it at least ensures that only effective and safe disinfectants will reach the market.
Basis for Further Testing
Products passing this test must be tested under increased difficulty of conditions and by more complicated procedures to establish full efficacy and safety.
These subsequent tests include:
- Phase 2 Step 1 Testing: This includes simulated-use testing where the actual efficacy of the disinfectant under conditions very similar to those of actual use is assessed. During this phase, the effectiveness of this product on different surfaces and under various environmental conditions is tested.
- Phase 2 Step 2 Testing: This phase is actually field trials and certainly includes more extensive testing to evaluate product performance in users. It incorporates testing on a bigger scale and for longer periods to establish the long-term efficacy and safety of the products.
Additional tests of this nature are important in ensuring that this disinfectant not only passes minimum efficacy requirements specified under EN 1275 but works consistently in practical applications while serving public health and safety.
Collaborate with Microbe Investigations Switzerland to ensure your disinfectants meet EN 1275 requirements. Our experienced team members ensure that appropriate testing and validation services are provided to maintain compliance. Contact MIS today for more information about our services and technical support in the area of antimicrobial testing.
