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.
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General information
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Status: PublishedPublication date: 2014-07Stage: International Standard to be revised [90.92]
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Edition: 2Number of pages: 78
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Technical Committee :ISO/TC 198ICS :11.080.01
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Life cycle
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Previously
WithdrawnISO 11135-1:2007
WithdrawnISO/TS 11135-2:2008
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Corrigenda / Amendments
PublishedISO 11135:2014/Amd 1:2018
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00
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Will be replaced by
Under developmentISO/DIS 11135.2
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