European norms for disinfection testing.

Disinfectant standards are required for several reasons. Primarily any company which wishes to market a new product in the European Union will need to apply a mark (known as a CE mark) which confirms that the product conforms to an accepted standard of quality. One of the simplest routes to being able to justify the CE mark is to test the product against European Standards. These give guidance on what is required to validate such claims. The disinfectant Standards are classified into phase 1, phase 2 and phase 3 tests, with phase 2 tests divided into step 1 and step 2. Phase 1 tests are simple suspension tests to look for basic antimicrobial activity of active agents whereas phase 2 tests are designed to simulate practical conditions for finished formulations. Phase 2, step 1 tests are, like phase 1 tests, suspension tests but using a wider range of organisms than the phase 1 tests, whereas phase 2, step 2 tests simulate the practical conditions under which the disinfectant will be used; for example hand surface tests or inanimate surface tests. Phase 3 tests are to be field tests under practical conditions although the methodology for these tests has not yet been established. Areas where Standards do not yet exist are being addressed and Standards will be written for these situations in the near future. Journal of Hospital Infection. 2008;70(1):8–10.