Maintain the quality management of your medical devices by ensuring they are sterilised in accordance with international guidelines.
ISO 11135:2014 Sterilisation of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilisation process for medical devices has been revised after seven years. This standard specifies requirements for the development, validation, and routine control of an ethylene oxide sterilisation process for medical devices in both the industrial and health care facility settings.
ISO 11135 covers:
• sterilising agent characterisation
• product safety, qualit,y and performance
• microbiological quality
• installation, performance, and operational qualification
• routine monitoring and control
• maintaining process effectiveness