Monday, February 10, 2014

New Medical Equipment Standards for the 4th Quarter 2013

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

  • ASTM E2524, 2008 Edition Reaffirmed in 2013, Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles
  • ASTM F565, 2004 Edition Reaffirmed in 2013, Standard Practice for Care and Handling of Orthopedic Implants and Instruments
  • ASTM F623, 1999 Edition Reaffirmed in 2013, Standard Performance Specification for Foley Catheter
  • ASTM F1611, 2000 Edition Reaffirmed in 2013, Standard Specification for Intramedullary Reamers
  • ASTM F2066, 2013 Edition with Editorial Correction, Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
  • ASTM G88, 2013 Edition, Standard Guide for Designing Systems for Oxygen Service
  • ASTM G175, 2013 Edition, Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
  • BS EN 1041, 2008 Edition with Amendment A1, Information supplied by the manufacturer of medical devices
  • BS EN 16081, 2011 Edition with Amendment A1, Hyperbaric chambers. Specific requirements for fire extinguishing systems. Performance, installation and testing
  • BS EN 60601-1, 2006 Edition with Amendment A1, Medical electrical equipment.  General requirements for basic safety and essential performance
  • DIN EN ISO 3826-1, 2013 Edition, Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
  • IEC 60601-2-17, Edition 3.0, Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
  • ISO 27427, 3rd Edition, Anaesthetic and respiratory equipment - Nebulizing systems and components

For similar standards please see the following pages:

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