Thursday, August 13, 2015

New Diagnostic Equipment Standards for the 2nd Quarter 2015

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


  • AAMI ST91, 2015 Edition, Flexible and semi-rigid endoscope processing in health care facilities
  • BS EN 60601-2-26, 2015 Edition, Medical electrical equipment. Particular requirements for the basic safety and essential performance of electroencephalographs
  • BS EN 60601-2-47, 2015 Edition, Medical electrical equipment. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
  • BS EN 62570, 2015 Edition, Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
  • BS EN ISO 15197, 2015 Edition, In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
  • IEC 60601-2-33 Amendment 2, Amendment 2 for Edition 3.0, Amendment 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
  • IEC 60601-2-37 Amendment 1, Amendment 1 for Edition 2.0, Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
  • IEC 61010-2-101, Edition 2.0, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
  • IEC 80601-2-71, Edition 1.0, Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
  • ISO 8600-2, 2nd Edition, Endoscopes - Medical endoscopes and endotherapy devices - Part 2: Particular requirements for rigid bronchoscopes


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