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ČSN EN ISO 11138-8 (855261)
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator
Translate name
STANDARD published on 1.3.2022
The information about the standard:
Designation standards: ČSN EN ISO 11138-8
Classification mark: 855261
Catalog number: 513749
Publication date standards: 1.3.2022
SKU: NS-1050124
The number of pages: 20
Approximate weight : 60 g (0.13 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11138-8 (855261):
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. NOTE For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load. 1.2 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. 1.3 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. NOTE - The method described in this document to establish a 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 a 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
Preview of the standard ČSN EN ISO 11138-8 (855261)
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