Endoscope Safety Testing
Basic safety and essential performance testing of endoscopic equipment to IEC 60601-2-18, from endoscopes to camera heads and light sources, with an ASCA summary test report for your FDA 510(k).
- IEC 60601-2-18
- IEC 60601-1
- ANSI/AAMI ES60601-1
Why Sigma
Endoscope safety data FDA reviewers recognize
We test the endoscope together with the equipment it is used with, against the particular standard and the general standard, in one program and one report.
- FDA ASCA-accredited for IEC 60601-2-18: your report comes with an ASCA summary test report for the 510(k).
- The whole endoscopic system: endoscopes, camera heads, camera control units and light sources, tested in the combinations you market.
- Rigid and flexible endoscopes: leakage current, insulation and temperature of every part that contacts the patient.
- One program with IEC 60601-1: particular and general requirements tested together for the same system.
What we test
Every clause your submission needs
Tested for each endoscope model and each combination of equipment you declare. See how we measure →
Standards we test to
Standards and accreditation status
Each result is reported under the accreditation that covers it.
| Standard | Scope | Accreditation |
|---|---|---|
| IEC 60601-2-18 | Particular requirements for the basic safety and essential performance of endoscopic equipment | ASCA · A2LA |
| IEC 60601-1 | General requirements for basic safety and essential performance | ASCA · A2LA |
| ANSI/AAMI ES60601-1 | US national version of IEC 60601-1, recognized by FDA | 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 first submission to post-market
Support across the product life cycle, for new devices and for changes to cleared ones.
Your challenges, our solutions
What manufacturers ask us most
“Which combinations of camera and light source do we need to test?”
We map your system configurations to the clauses that apply and tell you which combinations to send.
“Our distal end runs hot with the new light source.”
We measure the surface temperatures at the distal end and the light guide, and report them against the limits.
“The endoscope will be used with HF surgical devices.”
We test leakage current and insulation for that use, so the combination is covered in the report.
Your test report
A report ready to file
Clause-by-clause results with the measurements behind every verdict, per system configuration.
- Clause-by-clause verdicts for IEC 60601-2-18 and IEC 60601-1
- Patient and combined leakage current measurements
- Dielectric strength of the insertion portion
- Surface temperatures at the distal end and light guide
- Tested combinations of endoscope, camera and light source
- ASCA summary test report (within ASCA scope)
Additional tests
Complementary optical performance tests
Optical performance to the ISO 8600 series is within our A2LA ISO/IEC 17025 scope.
Accreditation
Accredited where it matters
Related services
Testing that usually goes with it
Resources
Learn more about endoscope testing
FAQ
Frequently asked questions
Is the report accepted by FDA as an ASCA report?
IEC 60601-2-18 and IEC 60601-1 are within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
Do I need to send the whole system?
Yes. We test the endoscope with the camera head, camera control unit and light source it is marketed with. We confirm the configurations and number of units in the quote.
Do you test rigid and flexible endoscopes?
Yes. Both are covered by IEC 60601-2-18, and we adapt the setup to the insertion portion and the applied parts of each design.
How fast can I get a quote?
Within 24 hours. Tell us the endoscopes, the equipment they are used with and the standards you need, and we reply with scope, price and timeline.
Request an endoscope safety 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