Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
Also Known As:
SKU136872396
Published by
Deutsches Institut für Normung
DIN
Publication Date2021-11
Pages CountPages14
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. 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. 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.
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| Descriptors | Bacterial count, Biochemicals, Bio-indicators, Biological, Biological analysis and testing, Biological hazards, Biological systems, Biology, Checks, Culture, Cultures (biology), Definitions, Germs, Incubation, Indicators, Inoculation, Medical sciences, Methods, Microbiological analysis, Microorganisms, Nutrient medium, Public health, Resistance, Sterilization (hygiene), Sterilizers, Surveillance (approval), Survival characteristics, Systems, Test germs, Test goods, Testing, Validation, Procedures, Processes |
| ICS Codes | 11.080.01 - Sterilization and disinfection in general |
| Language(s) | English |
| File Size | 1.8 MB |
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