European norms for testing disinfectants for the use in human medicine

In many countries, there are standardized test procedures for assessing the disinfectants’ efficacy. In order to standardize the inspection authorities’ test methods and assessments European-wide, the European Committee for Standardization (Comité Européen de Normalisation = CEN) created a technical committee for disinfectants, which developed test procedures for the assessment of chemical disinfectants. The test program of the European Committee for Standardization constitutes the current standard. The test methods are accepted by the respective national societies as far as possible.

Test methods of phase 2:

Quantitative suspension test (phase 2 / step 1) with the objective of assessing the test preparation’s spectrum of efficacy. The test preparation is diluted with water and an organic burden. This test shows whether a product reacts with substances, e.g. proteins, and whether its effect is influenced. The test is quantitative, i.e. the reduction of the organism number is determined in log₁₀ factors.
Practical test (phase 2 / step 2) with the objective of determining the test preparation’s efficacy under practical conditions. These tests are carried out under conditions which come close to practice. The tests of phase 2 / step 2 vary depending on the disinfectant’s application area. The results of the tests under practical conditions define the labeling of concentration and exposure time.

Overview on phase 2/step 1 – Norms (suspension tests)
(pdf-file)

Overview on phase 2/step 2 – Norms
(practical tests)
(pdf-file)

Exposure times/test organisms phase 2/step 1 – Norms (suspension tests)
(pdf-file)

Exposure times/test organisms phase 2/step 2 – Norms (practical tests)
(pdf-file)