BS EN ISO 11138-3:2006 - Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes – BSI British Standards

BS EN ISO 11138-3:2006

Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes

Status : Revised, Superseded, Withdrawn   Published : August 2006 Replaced By : BS EN ISO 11138-3:2009, BS EN ISO 11138-3:2017

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BS EN ISO 11138-3:2006 provides specific 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.

Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

Requirements for validation and control of moist heat sterilization processes are provided by BS EN ISO 17665.

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




Standard NumberBS EN ISO 11138-3:2006
TitleSterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
StatusRevised, Superseded, Withdrawn
Publication Date31 August 2006
Withdrawn Date30 November 2009
Normative References(Required to achieve compliance to this standard)ISO 11138-1:2006, ISO 18472
Informative References(Provided for Information)ISO 17665-1, ISO 14161, 93/42/EEC
Replaced ByBS EN ISO 11138-3:2009, BS EN ISO 11138-3:2017
ReplacesBS EN 866-3:1997, BS EN 866-7:2000
International RelationshipsEN ISO 11138-3:2006,ISO 11138-3:2006
Draft Superseded By04/30078103 DC
DescriptorsPackaging, Sterilization (hygiene), Pressure, Performance testing, Biological analysis and testing, Microorganisms, Temperature, Bioassay, Working range, Organism-activity determination, Sterilizers, Medical equipment, Steam sterilizers
ICS11.080.01
Title in FrenchSterilisation des produits de sante. Indicateurs biologiques. Indicateurs biologiques pour la sterilisation a la chaleur humide
Title in GermanSterilisation von Produkten fuer die Gesundheitsfuersorge. Biologische Indikatoren. Biologische Indikatoren fuer Sterilisationsverfahren mit feuchter Hitze
CommitteeCH/198
ISBN0 580 48860 8
PublisherBSI
FormatA4
DeliveryNo
Pages18
File Size413 KB
Price£130.00


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