BS EN ISO 11138-7:2019 Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results

BS EN ISO 11138-7:2019

Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results

Status : Current   Published : May 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.

It is not applicable to liquid immersion sterilization processes.




Standard NumberBS EN ISO 11138-7:2019
TitleSterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
StatusCurrent
Publication Date01 May 2019
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO/IEC Guide 2, ISO 18472, ISO 11737 (all parts), ISO 14937, ISO 20857, ISO 11135, ISO 9001, ISO 11138 (all parts), ISO 13485, ANSI/AAMI ST79, EN 1422, EN 285, ISO/IEC 17025, ISO 17665-1, ISO 19011, ISO/IEC 17011, ISO 11139:2018
ReplacesBS EN ISO 14161:2009
International RelationshipsEN ISO 11138-7:2019,ISO 11138-7:2019
Draft Superseded By17/30363625 DC
DescriptorsSterilizers, Sterilization (hygiene), Medical equipment, Instructions for use, Selection, Biological analysis and testing, Medical instruments, Sterile equipment, Bioassay, Statistical methods of analysis
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Indicateurs biologiques Directives générales pour la sélection, lutilisation et linterprétation des résultats
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Biologische Indikatoren Leitfaden für die Auswahl, Verwendung und Interpretation von Ergebnissen
CommitteeCH/198
ISBN978 0 580 99278 0
PublisherBSI
FormatA4
DeliveryYes
Pages74
File Size2.879 MB
Price£274.00


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