AAMI News March 2020

AAMI Standards Monitor Digest

Newly Published

  • Preorder: AAMI/ISO DTIR24971:2020, Medical devices—Guidance on the application of ISO 14971 More Info
  • Preorder: AAMI/ISO DTIR20416:2020, Medical devices—Post-market surveillance for manufacturers More Info
  • ANSI/AAMI RD47:2020, Reprocessing of hemodialyzers More Info
  • AAMI/ISO 13485:2016, Medical Devices—A Practical Guide, Advice from ISO/TC 210 More Info
  • ANSI/AAMI ST72:2019, Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing More Info
  • ANSI/AAMI/ISO 14117:2019, Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices More Info

Calls for Participation

  • AAMI ST/WG 95, Water Quality for Reprocessing Medical Devices.
    The working group is seeking general interest, user, and regulatory stakeholders to participate in the development of AAMI ST108/Ed.1, Water for the processing of medical devices.
    Contact: Amanda Benedict at abenedict@aami.org
  • AAMI ST/WG 40, Hospital Practices Steam Sterilization.
    The working group is seeking regulatory and general interest stakeholders to participate in the development of AAMI TIR109/Ed.1, External transport of medical devices processed by health care facilities.
    Contact: Amanda Benedict at abenedict@aami.org

To get updates on the latest standards activities, including calls for comments and notices about meetings, subscribe to AAMI’s free monthly Standards Monitor Online newsletter at www.aami.org/standardsmonitor.