Abstract
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
General information
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Status: Under developmentStage: CD approved for registration as DIS [30.99]
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Edition: 3
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Technical Committee :ISO/TC 198ICS :11.080.01
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Life cycle
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Previously
PublishedISO 11135:2014
PublishedISO 11135:2014/Amd 1:2018
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Now