BAS EN ISO 11138-2:2010
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
General Information
Status: Withdrawn
No. of pages: 14
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 11138-2:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
Lifecycle
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Original document and degree of correspondence
- EN ISO 11138-2:2009, identical
- ISO 11138-2:2006, identical