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EN 16615:2015
EN 16615:2015
Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area
II Phase / II step
Test organisms for bactericidal activity evaluation:
Staphylococcus aureus ATCC 6538
Pseudomonas aeruginosa ATCC 15442
Enterococcus hirae ATCC 10541

Temperature (°C): between 4 and 30
Contact time (min.):
min. 1 and max. either 5 or 60
Interfering substances:
Clean conditions – bovine albumin 0,3 g/l
Dirty conditions – bovine albumin 3,0 g/l + sheep erythrocytes 3 ml/l

Reduction (lg): ≥ 5,0
Test organisms for yeasticidal activity evaluation:
Candida albicans ATCC 10231
Temperature (°C): between 4 and 30
Contact time (min.):
min. 1 and max. either 5 or 60
Interfering substances:
Clean conditions – bovine albumin 0,3 g/l
Dirty conditions – bovine albumin 3,0 g/l + sheep erythrocytes 3 ml/l

Reduction (lg): ≥ 4,0

Chemical disinfectants and antiseptics Phase I tests

Quantitative suspension tests to establish that a product has biocidal activity without regard to specific conditions of intended use.

Chemical disinfectants and antiseptics Phase II / step 1 tests

Quantitative suspension tests to establish that a product has biocidal activity simulating practical conditions appropriate to its intended use.

Chemical disinfectants and antiseptics Phase II / step 2 tests

Quantitative laboratory tests simulating practical conditions e.g. surface, instruments, handwash and handrub tests.

Chemical disinfectants and antiseptics other tests

Other chemical disinfectants and antiseptics tests.