Wednesday, February 19, 2014

New Medical Technology Standards for the 4th Quarter 2014

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


  • AAMI ST79, Amendment 4 for 2010 Edition, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013)  
  • ASTM E788, 1997 Edition Reaffirmed in 2013, Standard Specification for Pipet, Blood Diluting
  • ASTM E923, 1997 Edition Reaffirmed in 2013, Standard Specification for Glass Westergren Tube, Reusable
  • ASTM E2280, 2013 Edition, Standard Guide for Fire Hazard Assessment of the Effect of Upholstered Seating Furniture Within Patient Rooms of Health Care Facilities
  • ASTM F1031, 2013 Edition, Standard Practice for Training the Emergency Medical Technician (Basic)
  • ASTM F2150, 2013 Edition, Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
  • ASTM F2602, 2013 Edition, Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
  • ASTM 51939, 2005 Edition Reaffirmed in 2013, Standard Practice for Blood Irradiation Dosimetry
  • BS EN 1041, 2008 Edition with Amendment A1, Information supplied by the manufacturer of medical devices
  • BS ISO 17049, 2013 Edition, Accessible design. Application of braille on signage, equipment and appliances
  • CWA 16697, 2013 Edition, Car-Adaptations for Disabled Drivers. Requirements, test methods and best practise guidelines
  • IEC 60601-1-6, Edition 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  • IEC 60601-1-10, Edition 1.1, Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
  • ISO 17049, 1st Edition, Accessible design - Application of braille on signage, equipment and appliances
  • ISO 51939, 3rd Edition, Practice for blood irradiation dosimetry


For similar standards, please see our Document Center List of Standards on Medical Technology and follow the links to the section that meets your interests.

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