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ISO 11135

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

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Organization: ISO
Publication Date: 1 October 2018
Status: active
Page Count: 10
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

ISO 11135
October 1, 2018
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
A description is not available for this item.
July 15, 2014
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the...
January 1, 1994
Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
This International Standard establishes requirements and guidance for validation and routine control of ethylene oxide sterilization processes for medical devices. Particular attention is drawn to...
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