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CEN
EN ISO 11138-3:2017

EN ISO 11138-3:2017

Current

Current

The latest, up-to-date edition.

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)

Published date

29-03-2017

Publisher

Comite Europeen de Normalisation

European foreword
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 carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of
        resistance to moist heat sterilization
Annex B (normative) - Calculation of z value and
        coefficient of determination, r[2]
Bibliography

ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.NOTE 2 National or regional regulations can provide requirements for work place safety.

Committee
CEN/TC 102
DevelopmentNote
Supersedes EN 866-3 and EN 866-7. (08/2006)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

12/30261215 DC : 0 BS EN 13060 - SMALL STEAM STERILIZERS
04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
PREN 13060 : DRAFT 2012 SMALL STEAM STERILIZERS
I.S. EN 13060:2014 SMALL STEAM STERILIZERS
VDI 6300 Blatt 1:2016-05 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
EN 13060:2014 Small steam sterilizers
DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
UNE-EN 13060:2015 Small steam sterilizers
BS EN 13060 : 2014 SMALL STEAM STERILIZERS

ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
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
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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