FDA Updated the list of Recognized Consensus Standards

The update includes two interesting standards:


  • ANSI/UL 2900-2-1 – Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
  • ISO 18562 “Biocompatibility evaluation of breathing gas pathways in healthcare applications” 

Both standards are worth to be taken into consideration also for international registrations.


The modification of the recognized consensus standards was published in the "Federal Register/Vol. 83, No. 110/Thursday, June 7, 2018/Notices".


You can search the database for recognized consensus standards including the modifications at CDRH Database.