Recognized standard
60601-2-33 Edition 4.0 2022-08
FDA recognition 12-347 · IEC · Radiology
Key facts
| Recognition number | 12-347 |
|---|---|
| Designation | 60601-2-33 Edition 4.0 2022-08 |
| Title | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETICRESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS. This document does… |
At a glance
- 1–9 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: