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Latest update : 19.03.2012
LNE / G-MED: quality certification of sterilization processes
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Quality certification of sterilization processes

For manufacturers performing sterilization and hospital service providers, LNE/G-MED offers QMS certification completed by the following standards:

  • NF EN ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-2: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • EN ISO 11137-3: Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
  • EN 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

This certification provides customers and competent authorities with quality assurance of a controlled sterilization process for a specific activity.

For information on the LNE/G-MED certification process, see the section Obtaining certification

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