Recognized standard
F2119-07 (Reapproved 2013)
FDA recognition 8-153 · ASTM · Materials
Key facts
| Recognition number | 8-153 |
|---|---|
| Designation | F2119-07 (Reapproved 2013) |
| Title | Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Aug 6, 2013 |
| Scope (excerpt) | 1.1 This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or external power). Anything not established to be MR-Safe or MR-Conditional is excluded. |
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: