STANDARD

Current

ÖNORM EN ISO 11138-2

Issue date: 2017 07 15

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

This document 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.

General information on ÖNORM EN ISO 11138-2

Format
Paper | 12 Pages
Language
German | English | Download GER/ENG
Publisher
Austrian Standards International

Timeline

An overview of the development of ÖNORM EN ISO 11138-2 from 1997 til today.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer Titel Ausgabedatum Art Link
Dokumentnummer
ISO 11138-1:2006
Titel
Sterilization of health care products — Biological indicators — Part 1: General requirements
Ausgabedatum
2006 06 26
Art
Standard
Dokumentnummer
ISO 18472:2018
Titel
Sterilization of health care products — Biological and chemical indicators — Test equipment
Ausgabedatum
2018 08 16
Art
Standard

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