BS EN ISO 11138-2:2017 pdf.Sterilization Of Health Care Products – Biological Indicators – Part2:Biological Indicators For Ethylene Oxide Sterilization Processes.
Iso 11138-1 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.
The ISO 11138 series represents the current “state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities involved in developing the standard. 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.
Standards exist providing requirements for the validation and control of ethylene oxide sterilization (see ISO 11135 and ISO 14937).
NOTE It is possible that some countries or regions have published other standards covering requirements for sterilization or biological indicators.
Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161.

ISO 11138-2:2017 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 29°C to 65°C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11138-1:2017, Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment.
4 General requirements
The requirements of ISO 11138-1 apply.
5 Test organism
5.1 The test organisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as required by this document.
NOTE 1 Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.
NOTE 2 Bacillus atrophaeus ATCC 9372, NCTC 10073, NCIMB 8058, DSM 2277, NRRL 13-4418 and CIP 77.18 have been found to be suitable1).
5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall be determined.
6 Suspension
The requirements of ISO 11138-1 apply.
7 Carrier and primary packaging
7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in ethylene oxide sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2017, 5.2 and Annex B.