BAS EN ISO 11140-1:2010
Sterilization of health care products - Chemical indicators - Part 1: General requirements
General Information
Status: Withdrawn
No. of pages: 38
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 29.06.2010
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 11140-1:2009, identical
- ISO 11140-1:2005, identical