BS EN ISO 11138-5:2017 Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes

BS EN ISO 11138-5:2017

Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes

Status : Current, Under review   Published : April 2017

Format
PDF

Format
HARDCOPY



What is this standard about?

 This is the fifth part of a five part standard (the ISO 11138 series) on the sterilization of health care products and biological indicators. 


The series represents the current “state-of-the-art” according to the expert manufacturers, users and regulatory authorities involved in developing this document. The intent is not to promote the use of biological indicators where such use is not advised, but rather to provide common requirements for the production of those biological indicators that are known to be in use today.

This standard covers general requirements, test organism, suspension, carrier and primary packaging, inoculated carriers and biological indicators, and population and resistance.

The other parts of the standard are:

Who is this standard for?

  • Sterilization equipment manufacturers
  • Sterilization service providers
  • Infection control professionals
  • Other professionals responsible for sterilization

Why should you use this standard?

Part 1 specifies 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. 

This document gives specific requirements for those biological indicators intended for use in low-temperature steam and formaldehyde sterilization processes.

Annex B gives rationales for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators. 

NOTE: A standard exists providing general requirements for the validation and control of low-temperature steam and formaldehyde sterilization processes (see ISO 25424). Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161.

What’s changed since the last update?

This standard is a full technical revision of the 2006 version. The following amendment has been made:

  • Requirements on determination of resistance characteristics (9.6) revised



Standard NumberBS EN ISO 11138-5:2017
TitleSterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
StatusCurrent, Under review
Publication Date30 April 2017
Normative References(Required to achieve compliance to this standard)ISO 11138-1:2017
Informative References(Provided for Information)ISO 14161, ISO 14937, EN 14180, ISO 25424
ReplacesBS EN ISO 11138-5:2006
International RelationshipsEN ISO 11138-5:2017,ISO 11138-5:2017
Draft Superseded By15/30321514 DC
DescriptorsMicroorganisms, Sterilizers, Performance testing, Medical equipment, Sterilization (hygiene), Low temperatures, Steam sterilizers, Bioassay, Microbiological analysis, Biological analysis and testing, Packaging, Formaldehyde
ICS11.080.01
11.080.20
Title in FrenchStérilisation des produits de santé - Indicateurs biologiques - Partie 5: Indicateurs biologiques pour la stérilisation à la vapeur d'eau et au formaldéhyde à basse température
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 5: Biologische Indikatoren für Sterilisationsverfahren mit Niedertemperatur-Dampf-Formaldehyd
CommitteeCH/198
ISBN978 0 580 89835 8
PublisherBSI
FormatA4
DeliveryYes
Pages18
File Size1.777 MB
Price£130.00


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