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ÖNORM EN ISO 18472:2006-09

Заменен
Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
1.1 This International Standard specifies the requirements for test equipment to be used to test chemical
and biological indicators for steam, ethylene oxide, dry heat and vaporized hydrogen peroxide processes for
conformity to the requirements given in ISO 11140-1 for chemical indicators, or the requirements given in the
ISO 11138 series for biological indicators. This International Standard also provides informative methods
useful in characterizing the performance of biological and chemical indicators for intended use and for routine
quality control testing.
ISO 11138-2, ISO 11138-3, ISO 11138-4, and ISO 11140-1 require the use of resistometers specified in this
International Standard, and these resistometers are used in conjunction with the test methods specified in the
appropriate parts of ISO 11138 and ISO 11140.
NOTE Resistometers for formaldehyde indicators are not included in this International Standard. Test methods using
laboratory apparatus for steam-formaldehyde are included in ISO 11138-5, ISO 11140-3 and ISO 11140-4.
1.2 This International Standard does not address the methods used to demonstrate compliance of
biological or chemical indicators to ISO 11138 and ISO 11140, as these are covered in the appropriate parts
of these standards. Indicators used with combination processes, such as washer-disinfection, are not covered
by this International Standard.
NOTE Test equipment and methods necessary for ISO 11140-3, ISO 11140-4 or ISO 11140-5 are specified in those
standards.
1.3 This International Standard does not address safety aspects of the test equipment because these are
usually covered by specific regional, national or local regulations.
Diese ÖNORM legt die Anforderungen an die Prüfausrüstung fest, die bei der Prüfung chemischer und biologischer Indikatoren für die Sterilisation mit Dampf, Ethylenoxid, trockener Hitze und verdampftem Hydrogenperoxid auf Übereinstimmung mit den in ISO 11140-1 für chemische Indikatoren oder der Normenreihe ISO 11138 für biologische Indikatoren angegebenen Anforderungen zu verwenden ist. Diese Norm stellt auch informative Verfahren zur Verfügung, die bei der Merkmalbestimmung der Leistung biologischer und chemischer Indikatoren für ihre vorgesehene Verwendung und bei der Routineprüfung der Qualitätskontrolle nützlich sind.
ICS
11.080.01 Sterilization. Including sterilization methods, air quality of surgery rooms, etc. / Стерилизация и дезинфекция в целом. Включая методы стерилизации, качество воздуха в операционных и т.д.