Precision Technical Reference

 

Key Considerations for Medical Device Design

Note: Opportunties for the development of Medical Magnetics and device evolution will require continual demanding physical characteristics and size, as well as more performance through design and design situations. These evolving characteristics will pose unique obstacles for successful magnetics solutions.

   
  Regulatory Quality & Reliability Trade-Offs:
 
  • FDA, UL, IEC (Agency Requirements)
  • Creepage/Clearance/Isolation
  • Patient Connect Requirements
  • Patient Contact Requirements
  • Cleanliness
  • Unique Test Requirements
  • Materials & Process Traceability (Six Sigma CPK levels)
  • Minimized Process Variation
  • Cost
  • Size
  • Performance
   
  Physical
 
  • Miniaturization - Ultra fine Wire (less than 0.0006in)
  • Biocompatibility
  • Unique Form Factor
  • Tight Tolerance
  • Mechanical Integrity