SS-EN-ISO-11135 › Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
SS-EN-ISO-11135
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2014 EDITION
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CURRENT
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Included in this current edition are the following subparts:
2014 EDITION - July 24, 2014
FOR 2014 EDITION AMENDMENT 1 SEE - Nov. 28, 2019
FOR 2014 EDITION AMENDMENT 1 SEE - Nov. 28, 2019
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
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Designation Name
SS-EN ISO 11135:2014
Revision Level
2014 EDITION
Status
Current
Publication Date
July 24, 2014
Language(s)
English
Page Count
100
International Equivalent
EN ISO 11135:2014(IDT); ISO 11135:2014(IDT)