What is this standard about?
This is the third 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 2: Biological indicators for ethylene oxide 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?
It specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators, including inoculated carriers and suspensions intended for use in the validation and monitoring of sterilization processes. This document gives specific requirements for those biological indicators intended for use in moist heat sterilization processes.
Moist heat as the sterilizing agent is defined in this document as dry saturated steam. While air-steam mixtures can be used in moist heat sterilization processes, the methods and performance requirements of this document might not be applicable for biological indicators used in such processes.
NOTE: Standards exist providing requirements for the validation and control of moist heat sterilization (see ISO 17665 series). 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 on population and resistance (clause 9) revised
- Annex A, in particular A.2.4 step 4 revised
- 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
