SRPS EN ISO 11140-1:2011

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

Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.