European Norms (EN)
Methods for determining the efficacy of disinfectants in accordance with European standards, including DIN EN 1500 and DIN EN 12791. These standards provide practical methods for testing bactericidal activity.
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According to Art. 2 German Medicines Act (AMG), hand disinfectants and antiseptics for skin, mucous membranes and wounds are medicines that are subject to authorisation but are available over the counter.
A preparations therapeutic indication is defined during authorisation. Depending on ingredients, mechanisms of effect and indications, medicinal products are divided into
- over-the-counter medicines
- pharmacy-only medicines and
- prescription-only medicines.
Instrument disinfectants come under the Medical Device Directive (MDD) and must have the CE Mark to be marketed in Europe (see also Medical devices).
Surface disinfectants for general disinfection of surfaces come under the biocide laws.
