What is this standard about?
This is the first 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.
This standard covers: general and specific manufacturing requirements, determination of population and resistance, and culture conditions.
The other parts of the standard are:
- Part 2: Biological indicators for ethylene oxide sterilization processes
- 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?
It specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
It also specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE 1: National or regional regulations can apply.
NOTE 2: This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
What’s changed since the last update?
This standard is a full technical revision of the 2006 version, which makes the following amendments:
- Normative references and bibliography updated
- Terms and definitions “FBIO-value” and “packaging system” deleted
- General manufacturing requirements (clause 4) including Table 1 revised, e.g. requirements on traceability added
- Requirements on carrier and the primary and secondary packaging revised General resistance requirements (6.1.2 and 6.4.3) revised
- Requirements on software validation (7.4) and detection systems (7.5) added
- For determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes the number of probes was increased and requirements revised (see Annex B)
