| IEC 61391-2 Edition 1.0 2010-01 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 12-228 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | Keith Wear FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2538 keith.wear@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This part of IEC 61391 defines terms and specifies methods for measuring the maximum depth of penetration and the local dynamic range of real-time ultrasound B-MODE scanners. The types of transducers used with these scanners include:
- mechanical probes;
- electronic phased arrays;
- linear arrays;
- curved arrays;
- two-dimensional arrays;
- three-dimensional scanning probes based on a combination of the above types.
All scanners considered are based on pulse-echo techniques. The test methodology is applicable for transducers operating in the 1 MHz to 15 MHz frequency range operating both in fundamental mode and in harmonic modes that extend to 15 MHz. However, testing of harmonic modes above 15 MHz is not covered by this standard.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | IYO |
| §892.1550 | System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | IYN |
| Guidance for Industry and FDA Staff Information for Manufacterers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070911.pdf |