Recognized standard
62494-1 Edition 1.0 (2008-08)
FDA recognition 12-215 · IEC · Radiology
Key facts
| Recognition number | 12-215 |
|---|---|
| Designation | 62494-1 Edition 1.0 (2008-08) |
| Title | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Oct 4, 2010 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 62494 specifies definitions and requirements for the EXPOSURE INDEX of images acquired with DIGITAL X-RAY IMAGING SYSTEMS. This standard is applicable to DIGITAL X-RAY IMAGING SYSTEMS used in general radiography for producing PROJECTION X-ray images for general applications, such… |
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: