Home » Compliance Management Blog- ESG, EHS, EHSQ » New Medical Equipment Standards for the 4th Quarter 2013

New Medical Equipment Standards for the 4th Quarter 2013

Kyle Bach

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:

You’ll also want to review these recent blogs: