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Norm
ÖNORM EN ISO 11138-8
Issue date: 2021 11 01
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
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...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
This document 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.
This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
ÖNORM EN ISO 11138-8
2021 11 01
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a r...
Norm
↖
Norm
Issue date :
2018 08 16
Sterilization of health care products — Biological and chemical indicators — Test equipment
Norm
Issue date :
2021 07 20
Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator
