As a result of the CEN TC 216 work program, and with the concurrence of the EU Biocides Directive, several BS EN (European Standards as adopted by the British Standards Institute, test methods have been issued. These pass–fail test methods detail how disinfectants should be tested against selected cultures under controlled laboratory conditions. They also require an evaluation of the laboratory test results against field test results (see Table III).
Disinfectant effectiveness tests are not yet routine, so most drug-industry microbiologists are unfamiliar with them. The protocols take a long time to learn and a long time to perform, which makes them expensive. In addition, they are difficult to do and are done infrequently, which makes it hard to maintain laboratory personnel proficiency and hard to produce reproducible results.
Sanitation process validation