ISO 17664:2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices

Standard No.
ISO 17664:2017
Release Date
2017
Published By
International Organization for Standardization (ISO)
Latest
ISO 17664:2017

ISO 17664:2017 Referenced Document

  • EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
  • ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
  • ISO 15883-2:2006 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
  • ISO 15883-3:2006 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
  • ISO 15883-4:2008 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
  • ISO 15883-6:2011 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
  • ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
  • ISO 17665-1:2006 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 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • 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 7000:2014 Graphical symbols for use on equipment - Registered symbols
  • ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
  • ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
  • ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

ISO 17664:2017 history

  • 2017 ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
  • 2004 ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices



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