Recognized standard
62359 Edition 2.1 2017-09 CONSOLIDATED VERSION
FDA recognition 12-316 · IEC · Radiology
Key facts
| Recognition number | 12-316 |
|---|---|
| Designation | 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION |
| Title | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This International standard is applicable to medical diagnostic ultrasound fields. This standard establishes - parameters related to thermal and non-thermal exposure aspects of diagnostic ultrasonic fields; - methods for the determination of an exposure parameter relating to temperature rise in… |
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: