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ISO 11140-1
Standard
update
Changes in test and performance requirements have been
Chemical indicators to monitor sterilization processes are described in ISO 11140-1 standard. The latest and revised 2014
introduced
version of this standard was published on November 2014 and supersedes the 2005 version. Sterilization process Type of indicator for which
monitored by the changes have been
ISO 11140-1:2014 Sterilization of health care products -- Chemical indicators -- Part 1: General requirements indicator introduced
requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or
chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) STEAM Test and performance requirements
1 and 5
This new version has some changes regarding the former one:
According to their characteristics and intended use, chemical indicators are still divided into six different categories, which EO 1 and 5 Test and performance requirements
are now termed indicator TYPES, instead of CLASSES as they were formerly called. This categorization has no hierarchical
The 6 indicator types are also categorized according to their main application into 3 categories: VH2O2 1 Test and performance requirements
e: "Exposure" or process indicator
s: "Special" indicator
i: "Internal" indicator
These letters can be optionally used in combination with the number stating type of indicator: e1, s2, i3, i4, i5, i6. VH2O2 3 and 4 Test and performance requirements
The table describes three categories according to the intended use.