BS EN ISO 11138-2:2006 - Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes – BSI British Standards

BS EN ISO 11138-2:2006

Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes

Status : Superseded, Withdrawn   Published : July 2006 Replaced By : BS EN ISO 11138-2:2009, BS EN ISO 11138-2:2017

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BS EN ISO 11138-2:2006 provides specific 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.

National or regional regulations could provide requirements for work place safety.




Standard NumberBS EN ISO 11138-2:2006
TitleSterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
StatusSuperseded, Withdrawn
Publication Date31 July 2006
Withdrawn Date30 November 2009
Normative References(Required to achieve compliance to this standard)ISO 18472, ISO 11138-1:2006
Informative References(Provided for Information)ISO 11135:1994, 93/42/EEC, ISO 14161:2000
Replaced ByBS EN ISO 11138-2:2009, BS EN ISO 11138-2:2017
ReplacesBS EN 866-2:1998, BS EN 866-8:2000
International RelationshipsEN ISO 11138-2:2006,ISO 11138-2:2006
Draft Superseded By04/30078099 DC
DescriptorsMedical equipment, Microorganisms, Microbiological analysis, Sterilization (hygiene), Sterilizers, Biological analysis and testing, Gas sterilizers, Performance testing, Organism-activity determination, Bioassay, Ethylene oxide
ICS11.080.01
Title in FrenchSterilisation des produits de sante. Indicateurs biologiques. Indicateurs biologiques pour la sterilisation a l'oxyde d'ethylene
Title in GermanSterilisation von Produkten fuer die Gesundheitsfuersorge. Biologische Indikatoren. Biologische Indikatoren fuer Sterilisationsverfahren mit Ethylenoxid
CommitteeCH/198
ISBN0 580 48857 8
PublisherBSI
FormatA4
DeliveryNo
Pages16
File Size381 KB
Price£130.00


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