FDA-recognized standard · ObGyn/Gastroenterology/Urology
ISO 8600-3: Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
Yes. FDA recognizes ISO 8600-3 Second edition 2019-08 as recognition 9-123, in part, entered 2019-12-23.
Recognized editions of ISO 8600-3
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 9-123 | ISO 8600-3 Second edition 2019-08 | 2019-12-23 | Partial | — |
What FDA does not recognize in ISO 8600-3 Second edition 2019-08
Recognition 9-123 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Section 5.1 Method A (distal window reference) Section 6.1 Method A
Regulations
FDA lists these classification regulations against ISO 8600-3: 21 CFR 876.1500, 21 CFR 884.1630, 21 CFR 884.1640, 21 CFR 884.1690, 21 CFR 884.1720.
Product codes that cite ISO 8600-3
24 FDA product codes cite ISO 8600-3, including FAJ, FAM, FAN, FBN, FBO.
- FAJ Cystoscope And Accessories, Flexible/Rigid
- FAM
- FAN
- FBN Choledochoscope And Accessories, Flexible/Rigid
- FBO
- FBP
- FDA
- FDF Colonoscope And Accessories, Flexible/Rigid
- FDT Duodenoscope And Accessories, Flexible/Rigid
- FER
- FGA
- FGB Ureteroscope And Accessories, Flexible/Rigid
- FGC
- FJL
- GCJ Laparoscope, General & Plastic Surgery
- GCM
- GCQ
- HET Laparoscope, Gynecologic (And Accessories)
- HEW
- HEX
- HIH Hysteroscope (And Accessories)
- LYK
- MKO
- MOK
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.