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About This Item

 

Full Description



Cross References:
ISO 11135-1:2007
ISO 11138-2:2006
ISO 11140-1:2005
ISO 11737-1
ISO 13485:2003
ISO 17664
ISO 10993-7
ISO 11138-1:2006
ISO 14161:2000
ISO 14937
ISO 15883-1
ISO 15883-2
ISO 15883-4
ISO/TS 15883-5
AAMI TIR15
AAMI TIR28:2001
ANSI/AAMI ST41:1999
AS/NZS 4187:2003
EN 1422:1997


Incorporates the following:
Corrigendum, September 2011
 

Document History

  1. BS EN ISO 11135:2014+A1:2019


    Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Most Recent
  2. 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
  3. BS DD CEN ISO/TS 11135-2:2008

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    Sterilization of health care products. Ethylene oxide-Guidance on the application of ISO 11135-1

    • Historical Version
  4. BS 11/30244091 DC


    BS 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

    • Historical Version
  5. BS EN ISO 11135-1:2007


    Sterilization of health care products. Ethylene oxide-Requirements for development, validation and routine control of a sterilization process for medical devices

    • Historical Version
  6. BS EN 550:1994


    Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization

    • Historical Version