BS EN ISO 11138-2:2017 Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes

BS EN ISO 11138-2:2017

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

Status : Confirmed, Current   Published : April 2017



What is this standard about?

This is the second 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 ethylene oxide sterilization processes. It specifies 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 29⁰ C to 65⁰ C.

NOTE: Standards exist providing requirements for the validation and control of ethylene oxide sterilization (see ISO 11135 and ISO 14937). 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 2009 version. The following amendments have been made:

  • Requirements of population and resistance (clause 9) revised, e.g. information to minimum D-value at 30⁰ C deleted
  • Annex A, in particular A.2.4 step 6 revised
  • Informative Annex B on rationale for the inclusion of a second D-value and deletion of the requirement for a minimum D-value at 30⁰ C added
  • Informative Annex ZA respective relationship between this European standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered was deleted

Standard NumberBS EN ISO 11138-2:2017
TitleSterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
StatusConfirmed, Current
Publication Date30 April 2017
Confirm Date20 July 2020
Normative References(Required to achieve compliance to this standard)ISO 18472:2018, BS EN ISO 18472:2018, ISO 11138-1:2017
Informative References(Provided for Information)ISO 14161, ISO 14937, ISO 11135
ReplacesBS EN ISO 11138-2:2009, BS EN ISO 11138-2:2006
International RelationshipsISO 11138-2:2017,EN ISO 11138-2:2017
Draft Superseded By15/30321505 DC
DescriptorsOrganism-activity determination, Ethylene oxide, Microorganisms, Sterilization (hygiene), Performance testing, Biological analysis and testing, Sterilizers, Bioassay, Microbiological analysis, Medical equipment, Gas sterilizers
Title in FrenchStérilisation des produits de santé. Indicateurs biologiques. Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Biologische Indikatoren. Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid
ISBN978 0 580 89832 7
File Size1.814 MB

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