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Medical Device Sterilisation: International Standards

Companies looking to sterilise and validate medical devices need to be familiar with following major standards.

ISO 13485:2003 Requirements for Quality Management System of Medical Device companies
ISO 11607-1:2006 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
ISO 15882:2008 Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
ISO 17665-1:2006 Moist Heat/Steam Sterilization method
ISO 25424:2009 Low temperature steam and formaldehyde method
ISO 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
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-2 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process

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