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New Medical Equipment Standards for the 1st Quarter 2015

Kyle Bach

Document Center Inc. is pleased to announce that the following New Standards on Medical Equipment in General are now available:


  • AAMI/IEC 80001-2-5, 2014 Edition, 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, 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
  • AAMI/ISO 10993-3, 3rd Edition Corrected Reprint, Biological evaluation of medical devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • DIN EN 13718-1, 2014 Edition, Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances
  • IEC 60601-1-SER, 2015 Edition, Medical electrical equipment – ALL PARTS
  • IEC 80001-2-5, Edition 1.0, Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems
  • ISO 80001-2-7, 1st Edition, 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


For more standards like these, please see our Document Center List of Standards on Medical Equipment in General.

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