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CEN
EN 866-2:1997/AC:1998

EN 866-2:1997/AC:1998

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - PARTICULAR SYSTEMS FOR USE IN ETHYLENE OXIDE STERILIZERS

Superseded date

01-07-2006

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Test organisms
6 Population of test organisms
7 Carriers
8 Resistance
Annexes
A (normative) Method for the determination of
resistance to ethylene oxide sterilization
B (informative) Bibliography

Defines requirements for inoculated carriers and biological indicators for use in assessment of the performance of sterilizers and sterilization processes using ethylene oxide gas as the sterilant. Meant for use in sterilizers using pure ethylene oxide gas or admixtures of the gas with diluent gases, in a sterilizing temperature range of 20 deg C to 65 deg C.

Committee
TC 102
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 866-2 : 1997 Identical
NS EN 866-2 : 97 AC 98 Identical
UNI EN 866-2 : 1998 Identical
NF EN 866-2 : 1997 Identical
DIN EN 866-2:1997-05 Identical
UNE-EN 866-2/AC:1998 Identical
SN EN 866-2 : 1997 Identical
BS EN 866-2:1998 Identical
I.S. EN 866-2:1997 Identical
NEN EN 866-2 : 1997 C1 1998 Identical

BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

EN 866-1 : 1997 BIOLOGICAL SYSTEMS FOR TESTING STERILIZERS AND STERILIZATION PROCESSES - GENERAL REQUIREMENTS

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