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
