We offer a wide range of tests for determining the efficacy of disinfectant products to be used in medical environments to disinfect medical devices. These products must be correctly classified following the rules of Medical Device Regulations as class IIa, IIb or class III. Annex 9 of the 93/42 – classification of medical devices as referenced in the MDR – rule 15 covers substances and other equipment intended to be used in medical environments to disinfect medical devices: All devices intended specifically used for disinfecting medical devices must be classified as Class IIa. All devices specifically intended to disinfect invasive medical devices must be classified as Class IIb device.
Specifically for disinfectant wipes, we offer the following tests:
Frequently Asked Questions
Is BIFMA HCF8.1 a required standard?
No, it is a guidance document for testing materials intended for a healthcare setting to demonstrate the resilience of materials to daily cleaning regiments.
Are all these tests required?
No, we would determine the intended application of the wipes to confirm which tests are most relevant for the wipes.
What are the acceptance criteria?
Each standard outlines the required log reduction for individual organisms under specific conditions for example E. coli require a 5 log reduction within 1 min for clean conditions.
What is the difference between clean and dirty conditions?
This refers to the inclusion of interfering substances in the test designed to the disinfectants ability to overcome the condition. Standards often make it clear which condition is required for instance in BS EN 13727 clean conditions are required for Handrub but dirty conditions are necessary for Handwash.
What is the purpose of Phase 2 Step 2, if a product has already past Phase 2 step 1?
The suspension tests only prove that the solution is capable of disinfecting in direct contact, however, phase 2 step 2 the wipe is tested in full to confirm its action as a whole system.