NA 176

DIN Standards Committee Health Technologies

Standards [CURRENT]

DIN EN ISO 11138-2
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

Title (German)

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

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.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-08 AA - Indicators  

Responsible european committee

CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices  

Responsible international committee

ISO/TC 198/WG 4 - Biological indicators  

Edition 2017-07
Original language German
Translation English
Price from 70.50 €
Table of contents

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