Recognized standard
61326-2-6 Edition 3.0 2020-10
FDA recognition 19-43 · IEC · General II (ES/EMC)
Key facts
| Recognition number | 19-43 |
|---|---|
| Designation | 61326-2-6 Edition 3.0 2020-10 |
| Title | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General II (ES/EMC) |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT, taking into account the particularities and specific aspects of this electrical equipment… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: