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About This Item

 

Full Description

Provides requirements and guidance

Cross References:
BS 5750:Part 1
BS 5750:Part 2
BS EN 556
BS EN 46001
BS EN 46002
EN 866-2
EN 1174-1
BS 5750:Part 0:Section 0.1
BS 5750:Part 0:Section 0.2
BS EN 552
BS EN 554
EN 724
EN 30993-7
EN 50103
90/385/EEC
93/42/EEC


Replaced by BS EN ISO 11135-1:2007 but remains current.

All current amendments available at time of purchase are included with the purchase of this document.
 

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


    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

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

    • Historical Version