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
- Accelerate Fatigue: Stent, Stent-Graft, Heart Valves
- Accute coating integrity and Particulate matter evaluation
- Corrosion: Cyclic Potentiodynamic, Galvanic, Degradation
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.