Methods of testing the antimicrobial efficacy of disinfectant products differ from country to country according to national standards and regulatory requirements. Within Europe, work is underway to harmonize disinfectant test methods for medical, veterinary, food and institutional applications within the European Standards Committee, CEN/TC216. In replacing existing British Standards, the new European Standards will also provide the technical basis for implementing European Directives concerned with the essential requirements for safety and efficacy of disinfectants, as in the draft Directive on Biocidal Products and the recently published Directive on Medical Devices.
The scope of CEN/TC216 includes terminology, requirements, test methods including potential efficacy under in use conditions, recommendations for use and labelling. The work programme began with 'Phase 1' quantitative suspension tests used as a basic screen to establish whether a product does or does not have bactericidal, fungicidal or sporicidal activity. Tests appropriate for the product in use are developed in working groups for each field of application, as 'Phase 2' tests covering an extended range of organisms (surface-dried and in suspension) and specified test conditions such as organic soiling, water hardness and temperature. The Medical Working Group is also producing tests for virucidal and mycobactericidal activity, biocides against Legionella, hand disinfection, surgical skin disinfection and antiseptics.
The technical issues raised in discussing tests for hygienic hand disinfection, surgical hand disinfection and medical instrument disinfection have highlighted differences in user, infection control and test laboratory practices across Europe. Other issues for debate include health and safety and ethical considerations arising from established methodology in Austria, Germany and the UK, whereby test organisms are applied directly to the hands of volunteers.