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