SR EN ISO 11140-1:2009

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

ISO 11140-1:2005 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 variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.

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General information

Status : Withdrawn
Approval date : 10/30/2009
Publish date : 11/1/2009
Withdrawal date : 4/30/2015
Number of pages : 38
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 11140-1:2006
Replaced by SR EN ISO 11140-1:2015