Medical Endoscopes
Optical Testing
Testing Services
We conduct testing and performance evaluation of medical endoscopes and opthalmic instruments 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:
- IEC 60601-2-18: Basic safety and essential performance of endoscopic equipment
- ISO 8600-1: Medical endoscopes and endotherapy devices
- 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
- IEC 62471: Photobiological safety of lamp systems
- ISO 15004-1 and ISO 15004-2: General requirements and Light Hazard protection of Opthalmic instrument
Test Reporting
Test Reports include the following measurements:
- Field of View
- Direction of View
- Depth of Field DOF
- Optimum Working Distance
- Noise and Dynamic Range
- Geometric Distortion as per Wang et. al., “Development of the local magnification method for quantitative evaluation of endoscope geometric distortion.”, Journal of Biomedical Optics 21, no. 5 (2016)
- Image Intensity Uniformity (IIU)
- Color performance as per the FDA/CDRH/OSEL Color Performance Review Tool for Endoscopy Devices
- Video Latency
- Photobiological safety