Sterilization Processes and Validation Training

The training covers the following standards.

• 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
• 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
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
• GHTF/SG3/N99-10 Quality Management Systems – Process Validation Guidance