[The principle of registration, evaluation and testing of disinfecting preparations].
Disinfectants are used to produce a state in which the number of living micro-organisms has been reduced to a level which is appropriate to the practical situation. For any products which are included in the Biocidal Directive 98/8/EC, for which specific activity is claimed, test data has to be approved by the regulatory authority and a product license obtained before the product can be offered for sale. Disinfectants can be recorded as biocidal products or medical devices. Presently, it is possible to measure the activity of a product on defined micro-organisms in specified experimental conditions. Efficacy is the result of the use of a product according to a defined application. To allow different requirements in different areas of application, separate tests and pass criteria have been or will be prepared for each of following three areas of application: medical, veterinary and group comprising food, industrial, domestic and institutional areas. The laboratory methods to be used for testing the activity of chemical disinfectants meets the European standards. The tests are categorised on a modular basis as follows: phase 1 tests, phase 2 step 1 tests, phase 2 step 2 tests and phase 3 tests. In order to claim that a product has disinfectant properties, suitable for use in the medical area, the product shall be tested according to European standards: phase 2 step 1 tests, phase 2 step 2 tests. Phase 1 tests are not required to support claims for chemical disinfectants used in human medicine. Only phase 1 tests are required to support claims for active substances for which no particular area of application is specified. Medical devices are subjects to the European Directive 93/42/EEC which requires that a product must carry a CE mark. Disinfectants which are intended specifically by its manufacturer to be used on medical devices are themselves medical devices and so these products, as well as conforming to the instrument disinfection European standards as specified in EN 14885, are also required to carry a CE mark.
Röhm-Rodowald
Ewa
E
Zakład Zwalczania Skazeń Biologicznych Narodowego Instytutu Zdrowia Publicznego-Państwowego Zakładu Higieny, Warszawa. erodowald@pzh.gov.pl
Jakimiak
Bozenna
B
Podgórska
Marta
M
D000891:Anti-Infective Agents, Local / Q000592:standards; D004202:Disinfectants / Q000592:standards*; D004203:Disinfection / Q000331:legislation & jurisprudence / Q000592:standards*; D004335:Drug and Narcotic Control; D004787:Environmental Pollution / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D004866:Equipment Contamination / Q000517:prevention & control*; D005062:European Union; D006801:Humans; D017053:Infection Control / Q000331:legislation & jurisprudence; D011044:Poland; D011358:Product Surveillance, Postmarketing
D000891:Anti-Infective Agents, Local; D004202:Disinfectants