Recognized standard
5799 Second edition 1991-08-01
FDA recognition 12-138 · ISO · Radiology
Key facts
| Recognition number | 12-138 |
|---|---|
| Designation | 5799 Second edition 1991-08-01 |
| Title | Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient |
| Standards developer | International Organization for Standardization |
| Specialty area | Radiology |
| Date of entry | Mar 31, 2006 |
| Device classes | Class 1 |
| Scope (excerpt) | This International Standard specifies methods for determining the ISO Speed and ISO average gradient of the film/process combinations used in medical and dental radiography other than mammography. Sensitometric procedures are descry bed for films exposed directly to X-rays. The purpose of this… |
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: