What is ISO 11138-8 about?
ISO 11138-8 is a series of documents for Sterilization of health care products, biological indicators that specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 111381:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
ISO 11138-8 is applicable to manufacturers of biological indicators (BIs) and to end-users of BIs who intend to, if required by their quality system, establish, validate, or confirm a RIT.
NOTE: The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in the use of this method to establish an RIT for biological indicators used to monitor dry heat, low-temperature steam formaldehyde, or vaporized hydrogen peroxide sterilization processes. ISO 11138-8, therefore, does not include these sterilization processes.
Who is ISO 11138-8 for?
ISO 11138-8 is applicable for-
- Manufacturers of biological indicators
- End-users of biological indicators
- Medical laboratories
Why should you use ISO 11138-8?
Biological indicators are utilized to test the effectiveness of the given sterilization process and the equipment used, by assessing microbial lethally according to the concept of sterility assurance level.
The purpose of a reduced incubation time procedure is to demonstrate recovery of the surviving test organisms within the specified reduced incubation time period. This guidance contained a protocol for validating an incubation time that was less than 7 d. The purpose of ISO 11138-8 is to describe an internationally agreed approach to the validation of the reduced incubation time of a biological indicator.
