Standards Development

Scope

1.1 This document 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 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.

1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT.

1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.

NOTE 1 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 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. This document, therefore, does not include these sterilization processes.

NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.

Purpose

The recommended reference incubation period for biological indicators is 7 days for traditional sterilization processes, however, most users of biological indicators use incubation times of less than 7 days for release of sterilized product. At the present time there is only a U.S. FDA guideline for testing and documenting an RIT. This procedure has limitations in that it is not definitive or statistically robust. Consequently it has not been globally accepted by international regulatory agencies, Notified Bodies or Medical Device manufacturers.

This proposed this standard will provide biological indicator manufacturers with a reference test method for determining an appropriate RIT for their product. The resulting documentation would then be utilized by medical device manufacturers with the envisioned support of regulatory agencies and Notified Bodies.

ISO has started with the development of this work item and reached the DIS stage. CEN/TC 102 intends to develop the work item in parallel and therefore would like to adopt the NWIP at the stage.