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Standard [CURRENT]

DIN EN ISO 11138-2:2017-07

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017); German version EN ISO 11138-2:2017

German title
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO 11138-2:2017); Deutsche Fassung EN ISO 11138-2:2017
Publication date
2017-07
Original language
German
Pages
15

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Publication date
2017-07
Original language
German
Pages
15
DOI
https://dx.doi.org/10.31030/2576966

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Overview

DIN EN ISO 11138-2 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN). The responsible German committee is Working Committee NA 063-04-08 AA "Indikatoren" ("Indicators") at DIN Standards Committee Medicine.

Content
ICS
11.080.20
DOI
https://dx.doi.org/10.31030/2576966
Replacement amendments

This document replaces DIN EN ISO 11138-2:2009-09 .

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