Recognized standard
60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION
FDA recognition 12-339 · IEC · Radiology
Key facts
| Recognition number | 12-339 |
|---|---|
| Designation | 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT. The scope of this standard is restricted to X-RAY EQUIPMENT where: - the X-RAY TUBE… |
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: