ISO 11135:2014
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
standard by International Organization for Standardization, 07/15/2014
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DIN 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)- Historical Version
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BS EN ISO 11135:2014
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices- Historical Version
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AAMI/ISO 11135:2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices- This is the most recent version of this document.
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CAN/CSA Z11135:15 (R2020)
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)- This is the most recent version of this document.
About This Item
Full Description
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.
Document History
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ISO 11135:2014
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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices- Most Recent
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ISO/TS 11135-2:2008
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1- Historical Version
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ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices- Historical Version
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ISO 11135:1994
Medical devices -- Validation and routine control of ethylene oxide sterilization- Historical Version
