FDA-recognized standard · General II (ES/EMC)
IEC 61326-1: Electrical equipment for measurement control and laboratory use - EMC requirements - Part 1: General requirements
Yes. FDA recognizes IEC 61326-1 Edition 3.0 2020-10 as recognition 19-42, in part, entered 2021-12-20.
Recognized editions of IEC 61326-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 19-42 | IEC 61326-1 Edition 3.0 2020-10 | 2021-12-20 | Partial | — |
What FDA does not recognize in IEC 61326-1 Edition 3.0 2020-10
Recognition 19-42 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 3 Terms, Definitions and Abbreviations Subclause 5.2.1 General Subclause 5.2.3 Assembly of EUT Subclause 5.4 Specification of FUNCTIONAL PERFORMANCE Clause 6 Immunity Requirements Clause 8 Test results and test report Clause 9 Instructions for use
Regulations
FDA lists these classification regulations against IEC 61326-1: 21 CFR 864.9245, 21 CFR 864.9285, 21 CFR 868.5830, 21 CFR 870.4250, 21 CFR 880.2800, 21 CFR 880.6500, 21 CFR 880.6600, 21 CFR 880.6710, 21 CFR 880.6860, 21 CFR 880.6870, 21 CFR 880.6880, 21 CFR 880.6991, 21 CFR 880.6992, 21 CFR 884.6150.
Product codes that cite IEC 61326-1
15 FDA product codes cite IEC 61326-1, including CAC, DWC, FLE, FRA, GKT.
- CAC Apparatus, Autotransfusion
- DWC
- FLE Sterilizer, Steam
- FRA Purifier, Air, Ultraviolet, Medical
- GKT
- JOJ Indicator, Physical/Chemical Sterilization Process
- KMG
- KMH
- KSN
- LDS
- MEC
- MLR Sterilizer, Chemical
- MQJ
- ORG
- OSZ
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.