Tuesday, July 19, 2016

New IT Applications in Health Care Technology Standards for the 2nd Quarter 2016

Document Center, Inc. is pleased to announce that the following Standards on IT Applicationsin Health Care Technology are now available;


  • AAMI/IEC 80001-2-1, 2012 Edition Reprint (ANSI Designation Dropped), Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples (ANSI/AAMI/IEC TIR80001-2-1:2012)
  • AAMI/IEC 80001-2-2, 2012 Edition Reprint (ANSI Designation Dropped), Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security
  • AAMI/IEC 80001-2-3, 2012 Edition Reprint (ANSI Designation Dropped), Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks (ANSI/AAMI/IEC TIR80001-2-3:2012)
  • AAMI/IEC 80001-2-4, 2012 Edition Reprint (ANSI Designation Dropped), Application of risk management for IT-networks incorporating medical devices, Part 2-4: Application guidance, General implementation guidance for healthcare delivery organizations
  • AAMI/IEC 80001-2-5, 2014 Edition Reprint (ANSI Designation Dropped), Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
  • AAMI/IEC 80001-2-7, 2014 Edition Reprint (ANSI Designation Dropped), Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
  • BS EN ISO 15225, 2016 Edition, Medical devices. Quality management. Medical device nomenclature data structure
  • BS EN ISO 21549-5, 2016 Edition, Health informatics. Patient healthcard data. Identification data
  • ISO 17251, 1st Edition, Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products
  • ISO 17523, 1st Edition, Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products
  • ISO 19256, 1st Edition, Health informatics - Requirements for medicinal product dictionary systems for health care
  • ISO 20440, 1st Edition, Health informatics - Identification of medicinal products - Implementation guide for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
  • ISO/IEEE 11073-10419, 1st Edition, Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
  • ISO/IEEE 11073-10424, 1st Edition, Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep apnoea breathing therapy equipment (SABTE)
  • ISO/IEEE 11073-10425, 1st Edition, Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)


For more standards like these, please refer to our Document Center List of Standards on IT Applications in Health Care Technology.