Application Note – Sterilization N.4
Standards for sterilization of “medical devices”
STANDARD | TITLE |
| ISO 13408-1:2008 | Aseptic processing of healthcare products – Part 1: General requirements |
| ISO 20857:2011 | Sterilization of healthcare products. Dry heat. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices. |
| ISO 11135-1:2007 | Sterilization of healthcare products. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices. Ethylene oxide. |
| ISO 14160:2011 | Sterilization of single use medical devices incorporating material of animal origin. Validation and routine control of sterilization by liquid chemical sterilants. |
| ISO 25424:2009 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices. |
| ISO 17665-1:2006 | Sterilization of healthcare products. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices. Ethylene oxide. Moist heat. |
| ISO 11137-1:2006 | Sterilization of healthcare products. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices. Radiation. Part 1: Requirements. |
| ISO 14937:2009 | Sterilization of healthcare products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process. |
