Tuesday, November 26, 2013

New Medical Equipment for the 3rd Quarter 2013

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


  • ASTM A908, 2003 Edition Reaffirmed in 2013, Standard Specification for Stainless Steel Needle Tubing
  • ASTM F1949, 1999 Edition Reaffirmed in 2013, Standard Specification for Medical Oxygen Delivery Systems for EMS Ground Vehicles
  • BS EN ISO 3826-1, 2013 Edition, Plastics collapsible containers for human blood and blood components. Conventional containers
  • BS EN ISO 8536-4, 2013 Edition with Amendment 1, Infusion equipment for medical use. Infusion sets for single use, gravity feed
  • BS EN ISO 10555-1, 2013 Edition, Intravascular catheters. Sterile and single-use catheters. General requirements
  • BS EN ISO 10555-3, 2013 Edition, Intravascular catheters. Sterile and single-use catheters. Central venous catheters
  • BS EN ISO 10555-4, 2013 Edition, Intravascular catheters. Sterile and single-use catheters. Balloon dilatation catheters
  • BS EN ISO 10555-5, 2013 Edition, Intravascular catheters. Sterile and single-use catheters. Over-needle peripheral catheters
  • BS EN ISO 19001, Corrigendum 1, In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
  • BS EN ISO 80601-2-12, Corrigendum 1, Medical electrical equipment. Particular requirements for basic safety and essential performance of critical care ventilators
  • IEC 60601-2-61, Edition 1.0, Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment



For similar standards, please go to our Document Center List of Standards on Medical Equipment.  You'll find links there to review the various standards on specific types of medical equipment.

I've also blogged on other new standards in this subject area recently.  So you'll want to review the following pages as well: