Recognized standard
60601-2-68 Edition 2.0 2025-02
FDA recognition 12-381 · IEC · Radiology
Key facts
| Recognition number | 12-381 |
|---|---|
| Designation | 60601-2-68 Edition 2.0 2025-02 |
| Title | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified… |
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: