SR EN ISO 11140-1:2015

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

ISO 11140-1:2014 specifies general 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) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

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General information

Status : Valid
Approval date : 4/30/2015
Number of pages : 40
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 11140-1:2009
Normative reference SR EN ISO 11135:2014
Normative reference SR EN ISO 11138-4:2007
Normative reference SR EN ISO 11140-4:2007
Normative reference SR EN ISO 11138-3:2009
Normative reference SR EN ISO 11140-3:2009
Normative reference SR EN ISO 11137-1:2006/A1:2013
Normative reference SR EN ISO 11138-1:2007
Normative reference SR EN ISO 11137-2:2015
Normative reference SR EN ISO 11138-2:2009
Normative reference SR EN ISO 17665-1:2007
Normative reference SR EN ISO 11138-5:2007
Normative reference SR EN ISO 18472:2006
Normative reference SR EN ISO 11137-1:2006
Normative reference SR EN ISO 11137-3:2006