BS EN ISO 11138-1:2006 - Sterilization of health care products. Biological indicators. General requirements – BSI British Standards

BS EN ISO 11138-1:2006

Sterilization of health care products. Biological indicators. General requirements

Status : Revised, Superseded, Withdrawn   Published : July 2006 Replaced By : BS EN ISO 11138-1:2017

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BS EN ISO 11138-1:2006 specifies general requirements for production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. Subsequent parts of ISO 11138 provide additional specific requirements for biological indicators for defined sterilization processes.

This part of BS EN ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of BS EN ISO 11138. Requirements for biological indicators for particular specified processes are provided in the other Parts. If no specific subsequent part is provided, this part applies.

It does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems.




Standard NumberBS EN ISO 11138-1:2006
TitleSterilization of health care products. Biological indicators. General requirements
StatusRevised, Superseded, Withdrawn
Publication Date31 July 2006
Withdrawn Date04 February 2019
Normative References(Required to achieve compliance to this standard)ISO 17665-1, ISO 11137-3:2017, ISO 18472:2018, ISO 11135:1994, ISO 11607-2, ISO 11137-2, ISO 8601, ISO 11137-1, ISO 13485, ISO 11607-1, ISO 15223, ISO 11737-1:2018, BS EN ISO 18472:2018
Informative References(Provided for Information)ISO 14937:2000, ISO 1000:1992, ISO/TS 11139, ISO 31, IEC 60027, ISO 14161:2000, ISO 10241:1992, ISO 14:1982, ISO 1000:1992/AMD 1:1998
Replaced ByBS EN ISO 11138-1:2017
ReplacesBS EN 866-1:1997
International RelationshipsEN ISO 11138-1:2006,ISO 11138-1:2006
Draft Superseded By04/30078095 DC
DescriptorsMedical equipment, Culture containers, Culture techniques, Sterilizers, Microbiological analysis, Labelling (process), Microorganisms, Performance testing, Sterilization (hygiene), Bioassay, Packaging, Biological analysis and testing
ICS11.080.01
Title in FrenchSterilisation des produits de sante. Indicateurs biologiques. Exigences generales
Title in GermanSterilisation von Produkten fuer die Gesundheitsfuersorge. Biologische Indikatoren. Allgemeine Anforderungen
CommitteeCH/198
ISBN0 580 48856 X
PublisherBSI
FormatA4
DeliveryNo
Pages50
File Size5.385 MB
Price£240.00


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