FDA-recognized standard · Cardiovascular
ISO 27185: Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels and Information to be Supplied - General Requirements
Yes. FDA recognizes ISO 27185 First edition 2012-02-15 as recognition 3-132, entered 2016-06-15.
Recognized editions of ISO 27185
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-132 | ISO 27185 First edition 2012-02-15 also ANSI AAMI ISO 27185:2012 | 2016-06-15 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 27185: 21 CFR 870.1750, 21 CFR 870.3600, 21 CFR 870.3610, 21 CFR 870.3620, 21 CFR 870.3630, 21 CFR 870.3680, 21 CFR 870.3700, 21 CFR 870.3720, 21 CFR 870.5310.
Product codes that cite ISO 27185
29 FDA product codes cite ISO 27185, including DTA, DTB, DTC, DTD, DTE.
- DTA
- DTB
- DTC
- DTD
- DTE
- DXY
- JOQ
- KRG
- LDF
- LPA
- LWO
- LWP
- LWS
- LWW
- MFA
- MKJ
- MRM
- MTE
- MVK
- NHW
- NIK
- NKE
- NSA
- NVN
- NVY
- NVZ
- OJX
- OSR
- OVJ
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.