BS EN ISO 11140-6:2022
Sterilization of health care products. Chemical indicators. Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
- Standard No.
- BS EN ISO 11140-6:2022
- Release Date
- 2022
- Published By
- British Standards Institution (BSI)
- Latest
- BS EN ISO 11140-6:2022
- Scope
- 1 Scope This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a) Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: — a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; — an alternative porous chemical indicator system equivalent in performan...
BS EN ISO 11140-6:2022 Referenced Document
- ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
- ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
- ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
- ISO 18472 Sterilization of health care products - Biological and chemical indicators - Test equipment
BS EN ISO 11140-6:2022 history
- 2022 BS EN ISO 11140-6:2022 Sterilization of health care products. Chemical indicators. Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
