Efficacy of Disinfectant Products
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 sprays, we offer the following tests:
Frequently Asked Questions
What materials would EN ISO 21530 be applicable to?
Any materials that would be used as the external device finish or furniture used within a dental setting that require disinfection.
Is this the most recent standard?
Yes, the 2004 standard was reviewed in 2024 but it did not require any updates so remains 2004.
Is EN ISO 21530 only applicable to dental settings?
No, although it was written initially for dentistry, it has become accepted within many healthcare settings as a required standard.
Why is bactericidal, fungicidal/yeasticidal, and sporicidal separate, if I need to have all of them?
Each organism has slightly different methods for testing and acceptance criteria due to the different ways they grow and react to disinfectants, so depending on the application you may need all of them but separating them adds clarity to how the tests are performed.