Quality certification of sterilization processes

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

EN 550: Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization. In May 2010, Standard EN550 will be replaced by 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 552: Sterilization of medical devices - Validation and routine control of sterilization by irradiation

In April 2009 standard EN 552 will be replaced by these standards:

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 554: Sterilization of medical devices - Validation and routine control of sterilization by irradiation

In April 2009 standard EN 554 will be replaced by standard EN 17665-1: Moist heat sterilization of health products

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