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New Medical Equipment Standards for the 1st Quarter of 2013

Kyle Bach

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

  • BS EN 60601-2-13, withdrawn, replaced by BS EN ISO 80601-2-13 below
  • BS EN ISO 20072, 2013 Edition, Aerosol drug delivery device design verification. Requirements and test methods
  • BS EN ISO 5356-2, 2012 Edition, Anaesthetic and respiratory equipment. Conical connectors. Screw-threaded weight-bearing connectors
  • BS EN ISO 80601-2-13, 2012 Edition, Medical electrical equipment. Particular requirements for basic safety and essential performance of an anaesthetic workstation
  • BS EN ISO 8359, 2009 Edition with Amendment 1 from 2013, Oxygen concentrators for medical use. Safety requirements
  • BS EN ISO 8835-2, withdrawn, replaced by BS EN ISO 80601-2-13 above
  • BS EN ISO 8835-3, withdrawn, replaced by BS EN ISO 80601-2-13 above
  • BS EN ISO 8835-4, withdrawn, replaced by BS EN ISO 80601-2-13 above
  • BS EN ISO 8835-5, withdrawn, replaced by BS EN ISO 80601-2-13 above
  • IEC 60601-2-20, Corrigendum 2, Medical electrical equipment – Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
  • IEC 60601-2-21, Corrigendum 1, Medical electrical equipment – Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
  • ISO 10524-3 Amendment 1, Amendment 1: Filtration and information to be supplied by the manufacturer, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves
  • ISO 7396-1 Amendment 3, Amendment 3: Terminology relating to alarm systems, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

If you’d like to see more standards on Medical Equipment, please review our page List of Standards for Anaesthetic, Respiratory and Reanimation Medical Equipment.  It’s just one of the many presentation pages of standards available on our website — all geared to make it easier for you to find and maintain the standards essential to your business.

Document Center Inc. is dedicated to providing you with the tools and services to provide you with confidence in your compliance information.  Keeping up with changing standards can be a challenge, but Document Center Inc. monitors over 500,000 different standards daily.  We know about the standards you use, so why not depend on our Standards Expertise?  You’ll find that you’ll be able to support your organization with confidence!