| ISO 8600-5 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
| Recognition Date | 2013-01-15 |
| Recognition List | 030 |
| Recognition Number | 9-39 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Quanzeng Wang FDA/OMPT/CDRH/OSEL/DBP/ 301-796-2612 quanzeng.wang@fda.hhs.gov |
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This part of ISO 8600 specifies a test method for determining the optical resolution of endoscopes for type testing. It is applicable to rigid endoscopes with optics designed for use in the practice of medicine for type testing. It is not applicable to endoscopes having a fibre-optic or opto-electronic imaging system.
| Regulation Number | Device Name | Device Class | Product Code |
| §884.1720 | Laparoscope, Gynecologic (And Accessories) | Class 2 | HET |
| §884.1690 | Hysteroscope (And Accessories) | Class 2 | HIH |
| §884.1640 | Culdoscope (And Accessories) | Class 2 | HEW |
| §884.1630 | Colposcope (And Colpomicroscope) | Class 2 | HEX |
| §884.1630 | Vaginoscope And Accessories | Class 2 | MOK |
| §876.1500 | Angioscope | Class 2 | LYK |
| §876.1500 | Anoscope And Accessories | Class 2 | FER |
| §876.1500 | Choledochoscope And Accessories, Flexible/Rigid | Class 2 | FBN |
| §876.1500 | Colonoscope And Accessories, Flexible/Rigid | Class 2 | FDF |
| §876.1500 | Cystoscope And Accessories, Flexible/Rigid | Class 2 | FAJ |
| §876.1500 | Cystourethroscope | Class 2 | FBO |
| §876.1500 | Duodenoscope And Accessories, Flexible/Rigid | Class 2 | FDT |
| §876.1500 | Endoscope, Flexible | Class 2 | GCQ |
| §876.1500 | Endoscope, Rigid | Class 2 | GCM |
| §876.1500 | Enteroscope And Accessories | Class 2 | FDA |
| §876.1500 | Kit, Nephroscope | Class 2 | FGA |
| §876.1500 | Laparoscope, General & Plastic Surgery | Class 2 | GCJ |
| §876.1500 | Resectoscope | Class 2 | FJL |
| §876.1500 | Sigmoidoscope And Accessories, Flexible/Rigid | Class 2 | FAM |
| §876.1500 | Sigmoidoscope, Rigid, Electrical | Class 2 | FAN |
| §876.1500 | Telescope, Rigid, Endoscopic | Class 2 | FBP |
| §876.1500 | Ureteroscope And Accessories, Flexible/Rigid | Class 2 | FGB |
| §876.1500 | Urethroscope | Class 2 | FGC |
| §884.1690 | Falloposcope | Class 2 | MKO |
| Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), Issued March 1996. |