Dear members, The FDA yesterday announced its complete recognition of the International Electrotechnical Commission’s standard IEC 61326-2-6 Edition 4.0 2025-06. The standard applies to basic safety and essential performance of in vitro diagnostic medical electrical equipment when exposed to electromagnetic disturbances.
| Date of Entry |
Specialty Task Group Area |
Recognition Number |
Extent of Recognition |
Standards Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 07/28/2025 | General II (ES/ EMC) |
19-57 | Complete | IEC | 61326-2-6 Edition 4.0 2025-06 | Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment |
