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ÖNORM EN 14348:2005-04
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
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Разработчик:
Зарубежные/ON
ICS:
11.080.20 Disinfectants and antiseptics / Дезинфицирующие и антисептические средства
Описание
This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal)
activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted
with hard water - or in the case of ready-to-use products - with water. Products can only be tested at a
concentration of 80 % or less as some dilution is always produced by adding the test organisms and
interfering substance.
This document applies to products that are used in the medical area including those that are covered by the
EEC/93/42 Directive on Medical Devices.
This document applies to areas and situations where disinfection is medically indicated. Such indications
occur in patient care, for example:
in hospitals, in community medical facilities and in dental institutions;
in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens
supplying products directly for the patients.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances
under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex E).
Diese ÖNORM legt ein Prüfverfahren (Phase 2/Stufe 1) und die Mindestanforderungen an die tuberkulozide oder mykobakterizide Wirkung von chemischen Desinfektionsmitteln fest, die in Wasser standardisierter Härte als homogenes, physikalisch stabiles Präparat vorliegen und die für die Desinfektion im medizinischen Bereich sowie für die Instrumentendesinfektion verwendet werden, unabhängig davon, ob diese Instrumente als Medizinprodukte definiert sind oder nicht.
Ключевые слова:
Medizin, Desinfektion, Desinfektionsmittel, chemisch, Antiseptikum, Suspension, Suspensionsversuch, Humanmedizin, Instrument, Instrumentendesinfektion, Prüfung, Prüfverfahren, Prüfeinrichtung, Prüfbericht, Eigenschaft, Tuberkulose, Mykobakterie, Begriffe, Terminologie, Chemikalie, Reagenzien, Material, Prüflösung, Berechnung, Auswertung, Validierung, Musterprüfbericht, Wirkungsprüfung, Beispiel, Dokumentation