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Standard ÖNORM EN ISO 11138-8 1.11.2021 preview

ÖNORM EN ISO 11138-8

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

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STANDARD published on 1.11.2021


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The information about the standard:

Designation standards: ÖNORM EN ISO 11138-8
Publication date standards: 1.11.2021
SKU: NS-1040881
The number of pages: 14
Approximate weight : 42 g (0.09 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

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Sterilization and disinfection in general

Annotation of standard text ÖNORM EN ISO 11138-8 :

Dieses Dokument legt die Anforderungen an ein Prüfverfahren fest, das zur Bestimmung oder Bestätigung einer reduzierten Inkubationszeit (en: reduced incubation time, RIT) zu verwenden ist, die kürzer ist als die in ISO 11138-1:2017, 7.3.2, festgelegte 7-tägige Referenz-Inkubationszeit für biologische Indikatoren, welche zur Überwachung von Sterilisationsverfahren mit feuchter Hitze oder mit Ethylenoxid (EO) eingesetzt werden. Dieses Dokument ist anzuwenden für Hersteller biologischer Indikatoren (en: biological indicators, BIs) sowie für Endbenutzer von BIs, die beabsichtigen, eine reduzierte Inkubationszeit zu bestimmen, zu validieren oder zu bestätigen, wenn dies von ihrem Qualitätsmanagmentsystem gefordert wird. Dieses Dokument ist nicht anzuwenden für biologische Indikatoren, die zur Überwachung von Sterilisationsverfahren mit trockener Hitze, der Niedertemperatur-Dampf-Formaldehyd-Sterilisation (en: low temperature steam formaldehyde, LTSF) oder Sterilisationsverfahren mit verdampftem Wasserstoffperoxid (en: vaporized hydrogen peroxide , VH2O2) eingesetzt werden.

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