BS EN ISO 11138-2:2017

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:

• Part 1: General requirements
• Part 3: Biological indicators for moist heat sterilization processes
• Part 4: Biological indicators for dry heat sterilization processes
• Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

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