Medical Endoscopes

Optical Testing

Testing Services

We offer testing services of medical endoscopes and provide test reports to use in 510(k) submissions to the FDA as well as in international regulatory submissions for medical device approval and registration. Measurements are aimed to evaluate device effectiveness for its intended use and to assess if the subject endoscope provides equivalent or better performance than predicate endoscopes. Sigma Scientific Services is an A2LA and FDA accredited medical safety and performance test laboratory.

Test Methods

Testing of medical endoscope systems as per the following relevant international optics and photonics standards for medical endoscopes and endotherapy devices:

  • ISO 8600-1: General requirements
  • ISO 8600-3: Determination of field of view and direction of view
  • ISO 8600-4: Maximum width of insertion point
  • ISO 8600-5: Determination of optical resolution
  • ISO 15739: Noise measurements
  • ISO 12233: Resolution and spatial frequency responses

Test Reporting

Test Reports include the following measurements:

  • Field of View
  • Depth of Field DOF
  • Optimum Working Distance
  • Noise and Dynamic Range
  • Geometric Distortion
  • Image Intensity Uniformity (IIU)
  • Color performance
  • Video Latency

Endoscope Testing