SS-EN-ISO-11138-8 › 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)
SS-EN-ISO-11138-8
-
2021 EDITION
-
CURRENT
Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ISO/IEC-13211-1Information technology - Programming languages - Prolog - Part 1: General core
ISO/IEC-16022
Information technology - Automatic identification and data capture techniques - Data Matrix bar code symbology specification
IEC-60529
Degrees of protection provided by enclosures (IP Code)
Designation Name
SS-EN ISO 11138-8:2021
Revision Level
2021 EDITION
Status
Current
Publication Date
Aug. 5, 2021
Language(s)
English
Page Count
20
International Equivalent
EN ISO 11138-8:2021(IDT); ISO 11138-8:2021(IDT)