04/30078099 DC : DRAFT JUL 2004

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ISO 11138-2 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: USE IN ASSESSING ETHYLENE OXIDE STERILIZATION PROCESSES

Available format(s):

Superseded date: 31-07-2006

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carrier and biological indicators
9 Population and resistance
Annex A (normative) Method for determination of resistance to
ethylene oxide sterilization
A.1 General
A.2 Method
A.3 Determination of resistance

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ISO 11138-2

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Comment Closes On
Committee	LBI/35
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 11138-2:2017

Standards Referencing This Book - (Show below) - (Hide below)

ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 14161:2009	Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
EN ISO 11135:2014	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN ISO 11138-1:2017	Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
ISO 18472:2006	Sterilization of health care products Biological and chemical indicators Test equipment
EN ISO 18472:2006	Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results

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