Wednesday, October 15, 2014

New Medical Equipment Standards for the 3rd Quarter 2014

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

  • BS EN 13718-1, 2014 Edition, Medical vehicles and their equipment. Air ambulances. Requirements for medical devices used in air ambulances
  • BS EN 60601-1-8, Corrigendum1 for the 2007 Edition with Amendment 1, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-1 Amendment 1, Corrigendum 1 for Amendment 1,  Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 62353, Edition 2.0, Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
  • IEC 62354, Edition 3.0, General testing procedures for medical electrical equipment
  • IEC 80002-3, Edition 1.0, Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
  • ISO 19244, 1st Edition, Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
  • ISO/DIS 13485, Public Review Draft for the proposed 3rd Edition, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

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

You may also want to review some of my previous blogs: