Recognized standard
11990 Third edition 2018-08
FDA recognition 12-323 · ISO · Radiology
Key facts
| Recognition number | 12-323 |
|---|---|
| Designation | 11990 Third edition 2018-08 |
| Title | Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs |
| Standards developer | International Organization for Standardization |
| Specialty area | Radiology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies a method of testing the continuous wave (cw) laser resistance of the shaft of a tracheal tube and the cuff regions including the inflation system of tracheal tubes designed to resist ignition by a laser. NOTE 1 When interpreting these results, the attention of the user is… |
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: