ISO 13485 - Quality certification of sterilization processes

For manufacturers performing sterilization and hospital service providers, GMED 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.

 To request a proposal, contact us.