FDA-recognized standard · ObGyn/Gastroenterology/Urology
ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
Yes. FDA recognizes ISO 8600-1 Fourth Edition 2015-10-15 as recognition 9-110, entered 2016-04-04.
Recognized editions of ISO 8600-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 9-110 | ISO 8600-1 Fourth Edition 2015-10-15 | 2016-04-04 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 8600-1: 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 8600-1
24 FDA product codes cite ISO 8600-1, 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.