Recognized standard
60601-2-8 Edition 2.1 b:2015
FDA recognition 12-301 · IEC · Radiology
Key facts
| Recognition number | 12-301 |
|---|---|
| Designation | 60601-2-8 Edition 2.1 b:2015 |
| Title | Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jun 27, 2016 |
| Scope (excerpt) | IEC 60601-2-8:2010+A1:2015 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and… |
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: