Tuesday, June 4, 2013

New Medical Diagnostic Equipment Standards for the 1st Quarter 2013

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


  • BS EN 12470-3 (Withdrawn - Use BS EN ISO 80601-2-56), Clinical thermometers. Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
  • BS EN 12470-4, (Withdrawn - Use BS EN ISO 80601-2-56), Clinical thermometers. Performance of electrical thermometers for continuous measurement
  • BS EN 12470-5, (Withdrawn - Use BS EN ISO 80601-2-56), Clinical thermometers. Performance of infra-red ear thermometers (with maximum device)
  • BS EN ISO 80601-2-56, 2012 Edition, Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
  • BS EN 60601-2-22, 2013 Edition, Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • BS EN ISO 19001, 2013 Edition, In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
  • BS ISO 8600-1, 2013 Edition, Endoscopes. Medical endoscopes and endotherapy devices. General requirements
  • ISO 19001, 2nd Edition, In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
  • ISO 8600-1, 3rd Edition, Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements
  • IEC 60601-2-33, Edition 3.1, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

If you need to see more standards on this topic, check out Document Center's List of Standards on Medical Diagnostic Equipment.  

Medical Diagnostic Equipment includes a wide range of products, from medical imaging machines to clinical thermometers.  This type of equipment can be found in physician's offices, clinics, emergency rooms and other hospital and medical settings.

The industry is highly regulated, so the use of industry standards to comply with various export requirements is widespread.  Document Center Inc. provides both standards and support services to the Medical Device Industry.  Let Document Center be your Standards Experts.