Monday, May 9, 2016

New Anaesthetic, Respiratory and Reanimation Equipment Standards for the 2nd Quarter 2016

Document Center Inc. is pleased to announce that the following New Standards on Anaesthetic, Respiratory and Reanimation Equipment are now available:


  • ANSI/AAMI/IEC 60601-2-4, 2010 Edition Reapproved in 2015, Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators
  • BS EN ISO 5360, 2016 Edition, Anaesthetic vaporizers. Agent-specific filling systems
  • BS EN ISO 7396-1, 2016 Edition, Medical gas pipeline systems. Pipeline systems for compressed medical gases and vacuum
  • BS EN ISO 11197, Withdrawn and replaced by BS ISO 11197, Medical supply units
  • BS EN ISO 11408, 2016 Edition, Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information
  • BS ISO 11197, 2016 Edition, Medical supply units
  • ISO 5360, 4th Edition, Anaesthetic vaporizers - Agent-specific filling systems
  • ISO 7396-1, 3rd Ediiton, Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
  • ISO 11197, 3rd Edition, Medical supply units
  • ISO 14408, 3rd Edition, Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
  • SS EN 62366-1, Edition 1, Medical devices - Part 1: Application of usability engineering to medical devices (English language edition)
  • SS EN ISO 10079-1, Edition 4, Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) (Swedish Standard) English Language Edition