Recognized standard
/TS 10974 Second edition 2018
FDA recognition 8-464 · ISO · Materials
Key facts
| Recognition number | 8-464 |
|---|---|
| Designation | /TS 10974 Second edition 2018 |
| Title | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Jun 7, 2018 |
| Scope (excerpt) | This document is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole… |
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: