Gli standard che riguardano la sterilizzazione dei “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 charactterization of a sterilising agent and the development, validation and routine control of a sterilization process.

Fonte: ISO Standards