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Infection Control Division

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.

Intended use Type Category Description


(intended use)
Indicate exposure to a process to allow differentiation 1 e1 "Exposure" or process
between unprocessed and processed items, and/or indicate indicator indicator complies with the performance requirements outlined in ISO 11140-1:2014. There is a transition period for
gross failure of a sterilization process updating all documents with the new terms adopted by the updated version of ISO 11140-1, so it will not be unusual to come
across documents applicable to the healthcare setting where the prescribed terms might still be applied. Still, the user will
Indicators for use in special applications, e.g. Bowie and Dick "Special" indicator (e.g. choose the chemical indicator type based on the information about the sterilization process he wants to monitor, and with
2 s2 the guidance of manufacturers.
type test Bowie-Dick)

Indicators to be placed inside This indicator only 3 i3 "Internal" indicator


individual load items and to assess reacts to one critical Single variable
attainment of the critical process process variable indicator
variables at the point of placement
This indicator reacts to 4 i4 "Internal" indicator
more than one critical Multivariable indicator
process variable

This indicator reacts to 5 i5 "Internal" indicator


all critical process Integrating indicator
variables

This indicator reacts to 6 i6 "Internal" indicator


all critical process Emulating indicator
variables