Endoscope Optical Performance Testing
Optical performance testing of rigid and flexible endoscopes to the ISO 8600 series, from field of view and resolution to color and latency, with reports ready for design verification and your FDA 510(k).
- ISO 8600 series
- ISO 15739
- ISO 12233
Why Sigma
Objective optical data for every endoscope
We measure what your endoscope shows, with calibrated imaging systems and traceable optical targets, and report it the way design reviews and FDA submissions need.
- ISO 8600 methods: field of view, direction of view, resolution and depth of field measured to the endoscope standards.
- Calibrated and traceable: imaging systems and optical targets with traceable calibration.
- Rigid and flexible endoscopes: including camera heads, video processors and light sources.
- Accredited by A2LA: the ISO 8600 series, ISO 15739, ISO 12233 and IEC 62471 are within our ISO/IEC 17025 scope.
What we measure
The full picture of image quality
Measured for each endoscope model and each camera, processor and light source you combine it with. See how we measure →
Standards we test to
Standards and accreditation status
Optical tests to these standards are within our A2LA ISO/IEC 17025 scope (certificate 4896.01). Endoscope safety to IEC 60601-2-18 is FDA ASCA accredited.
| Standard | Scope | Accreditation |
|---|---|---|
| ISO 8600-1 | Endoscopes: general requirements | A2LA |
| ISO 8600-3 | Determination of field of view and direction of view | A2LA |
| ISO 8600-4 | Determination of maximum width of insertion portion | A2LA |
| ISO 8600-5 | Determination of optical resolution of rigid endoscopes with optics | A2LA |
| ISO 15739 | Noise and dynamic range measurements | A2LA |
| ISO 12233 | Resolution and spatial frequency response | A2LA |
| IEC 62471 | Photobiological safety of lamps and lamp systems | A2LA |
| IEC 60601-2-18 | Basic safety and essential performance of endoscopic equipment. See endoscope safety → | ASCA · A2LA |
Don’t see your standard? Contact us; we will tell you whether we can test to it and how it would be reported.
When you need it
From feasibility to production
Objective optical data at every stage of the endoscope life cycle.
Your challenges, our solutions
What manufacturers ask us most
“Our image looks sharp in the center but not at the edges.”
We measure resolution, distortion and uniformity across the whole field of view, so you see where the image degrades.
“Which optical data does FDA expect?”
We help you choose the optical parameters for your device type and report them with the method and equipment described.
“We need to show we match the predicate.”
We test both endoscopes with the same setup and targets, so the comparison holds up.
Your test report
A report ready for review
Every measured parameter, with the method, the calibrated equipment and representative images.
- Field of view and direction of view
- Resolution, depth of field and working distance
- Noise, dynamic range and distortion
- Uniformity and color reproduction
- Video latency and light output
- A2LA accredited optical test methods
Accreditation
Accredited optical testing
Related services
Testing that usually goes with it
Resources
Learn more about endoscope testing
FAQ
Frequently asked questions
Are these tests accredited?
Yes, by A2LA. Optical performance testing to ISO 8600-1, -3, -4 and -5, ISO 15739 and ISO 12233 is within our A2LA ISO/IEC 17025 scope (certificate 4896.01). The report is issued under our A2LA accreditation. Endoscope safety to IEC 60601-2-18 is FDA ASCA accredited and can be tested in the same program.
Can I use the results in a 510(k)?
Yes, as performance data. The report describes the methods, the calibrated equipment and the results, so reviewers can follow how each value was obtained.
What do I need to send?
The endoscope with the camera head, processor and light source it is used with, and its optical specifications. We send a checklist with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the endoscope, the parameters you need and the intended use, and we reply with scope, price and timeline.
Request an endoscope optical testing quote
Tell us about your device and the standards you need. You’ll have a quote within 24 hours.
(305) 239-4441 info@sigmascientific.us 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325