SS-EN-ISO-11135-AM1 › Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
SS-EN-ISO-11135-AM1
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2014 EDITION AMENDMENT 1
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CURRENT
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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.
To find similar documents by classification:
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
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Designation Name
SS-EN ISO 11135:2014/A1:2019
Revision Level
2014 EDITION AMENDMENT 1
Status
Current
Publication Date
Nov. 28, 2019
Language(s)
English
Page Count
28
International Equivalent
EN ISO 11135:2014/A1:2019(IDT); ISO 11135:2014/Amd 1:2018(IDT)