Stent SEM Inspection after Accelerated Fatigue 400 M cycles
Stent SEM Inspection after Accelerated Fatigue 400 M cycles

SEM and Optical Inspection: Measured parameters

  • Optical inspection : geometric dimensions + pictures
  • Scanning Electron Microscopy Inspection (SEM) : Observed defects are recorded (pictures).  Morphological and dimensional characteristics of defected are estimated.

SEM and Optical Inspection: Scope

  • All types of medical devices

SEM and Optical Inspection: Applicable standards

  • Based on associated tests requirements

SEM and Optical Inspection: Associated tests

SEM and Optical Inspection: Test method description

Scanning Electron Microscopy (SEM): Device are observed using secondary electron emission to visualize the morphology and the topography of the inspected surface, and detect potential inter or intra-granular defects, cracks, crevices, pitting or any abnormal surface configuration. The most significant and representative surface defects are recorded (photography) and dimensional characteristics measured. Observations with secondary electron emission with SEM X25 to X200000 magnifications. Dimension of defect are measured with a precision of +/-5%.

Optical inspection: Samples are placed directly or with an intermediate support on the Smartscope tray. Dimensions defined in the protocol are measured. Magnification is up to X145 with precision of +/-5µm.