Friday, June 6, 2014

New Medical Equipment Standards for the 1st Quarter 2014

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

  • ASTM E2597, 2014 Edition, Standard Practice for Manufacturing Characterization of Digital Detector Arrays
  • ASTM F1218, 1989 Edition Reaffirmed in 2014, Standard Specification for Bronchoscopes (Rigid)
  • ASTM F1984, 1999 Edition Reaffirmed in 2014, Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
  • ASTM F2211, 2013 Edition (no longer withdrawn), Standard Classification for Tissue Engineered Medical Products (TEMPs)
  • BS EN 1283, Withdrawn and replaced by BS EN ISO 8637 and BS EN ISO 8638, Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • BS EN 60601-1-9, 2008 Edition with Amendment 1, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for environmentally conscious design
  • BS EN ISO 8637, 2014 Edition, Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8638, 2014 Edition, Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BS ISO 27427, 2013 Edition, Anaesthetic and respiratory equipment. Nebulizing systems and components
  • IEC 60601-1-2, Edition 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • IEC 60601-2-2, Corrigendum for the 4th Edition, Medical Electrical Equipment - Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories
  • IEC 62570, Edition 1.0, Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
  • ISO 10555-1, 2nd Edition 2nd Reprint, Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
  • ISO 16571, 1st Edition, Systems for evacuation of plume generated by medical devices
  • ISO 17218, 1st Edition, Sterile acupuncture needles for single use

For similar standards, please see our Document Center List of Standards on Medical Equipment and follow the links to the specific areas in this ICS code.

You'll also want to review my other blogs for this subject:

And to learn about even more new standards:

New Ophthalmic Equipment Standards for the 1st Quarter 2015