Guideline for technical quality assurance (TQA) of ultrasound devices (B-Mode) - Version 10 (July 2012)

Ultraschall in der Medizin

Volumn 33, Issue 6, 2012, Pages 544-549

  Kollmann, C ^a   Dekorte, C ^b   Dudley, N J ^c   Gritzmann, N ^d   Martin, K ^e   Evans, D H ^f  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c UNITED LINCOLNSHIRE HOSPITALS NHS TRUST   (United Kingdom)

^d Gruppenpraxis für Radiologie   (Austria)

^e UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^f UNIVERSITY OF LEICESTER   (United Kingdom)

Author keywords

physics; QA QC; safety; technical aspects; ultrasound

Indexed keywords

CLINICAL COMPETENCE; COMPUTER ASSISTED DIAGNOSIS; COMPUTER PROGRAM; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; ECHOGRAPHY; EQUIPMENT; EQUIPMENT DESIGN; EUROPE; HEALTH CARE QUALITY; HUMAN; IMAGE QUALITY; PRACTICE GUIDELINE; QUALITY CONTROL; STANDARD;

CLINICAL COMPETENCE; EQUIPMENT DESIGN; EUROPE; HUMANS; IMAGE INTERPRETATION, COMPUTER-ASSISTED; PHANTOMS, IMAGING; QUALITY ASSURANCE, HEALTH CARE; QUALITY CONTROL; SOFTWARE DESIGN; ULTRASONOGRAPHY;

EID: 84870863278     PISSN: 01724614     EISSN: 14388782     Source Type: Journal    
DOI: 10.1055/s-0032-1325347     Document Type: Article

References (34)

1. King D. M., Hangiandreou N. J., Tradup D. J. et al. Evaluation of a low-cost liquid ultrasound test object for detection of transducer artefacts. Phys Med Biol: 2010; 55 N557 N570
2. Dudley N. J., Griffith K., Houldsworth G. et al. A review of two alternative ultrasound quality assurance programmes. Eur J Ultrasound: 2001; 12 233 245 (Pubitemid 32567553)
3. Gibson N. M., Dudley N. J., Griffith K. A Computerised Ultrasound Quality Control Testing System. Ultrasound Med Biol: 2001; 27 1697 1711 (Pubitemid 34143131)
4. Kollmann C., Dolezal L. Technical Quality Evaluation of diagnostic ultrasound systems - a comprehensive overview of regulations and developments. EFSUMB European Course Book Chapter 25: 2011; http://www.efsumb.org/ecb/ecb-01. asp (accessed 26.6.2012)
5. Thijssen J. M., Weijers G., deKorte C. L. Objective performance testing and quality assurance of medical ultrasound equipment. Ultrasound Med Biol: 2007; 33 460 471 (Pubitemid 46275192)
6. Institute of Physics and Engineering in Medicine (IPEM) Quality Assurance of Ultrasound Imaging Systems, Report no. 102. York: 2009
7. American College of Radiology (ACR) ACR Technical Standard for diagnostic medical physics performance monitoring of real time ultrasound equipment Res.3 -2011. www.acr.org/Quality-Safety/Standards-Guidelines/Technical-Standards-by- Modality/Medical-Physics (accessed 26.6.2012)
8. American College of Radiology (ACR) Ultrasound Accreditation Program Requirements; revision 3/23/12. www.acr.org/Quality-Safety/Accreditation/ Ultrasound (accessed 26.6.2012)
9. International Electrotechnical Commission (IEC) IEC 60601-2-37, Ed. 2: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Standard Geneva: 2007
10. International Electrotechnical Commission (IEC) IEC/TR 60854 Edition 1.0. Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment. Geneva: 1986
11. International Electrotechnical Commission (IEC) IEC 61157 Ed. 2.0 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. Standard Geneva: 2007
12. International Electrotechnical Commission (IEC) IEC 61161 Ed.3: Ultrasonics - Power measurement - Radiation force balances and performance requirements. Draft Geneva: 2012
13. International Electrotechnical Commission (IEC) IEC 61391-1. Edition 1.0. Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response. Geneva: 2006
14. International Electrotechnical Commission (IEC) IEC 61391-2. Edition 1.0. Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range. Geneva: 2010
15. International Electrotechnical Commission (IEC) IEC 61685. Edition 1.0. Ultrasonics - Flow measurement systems - Flow test object. Geneva: 2001
16. International Electrotechnical Commission (IEC) IEC 62127-1. Edition 1.0. Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz. Geneva: 2007
17. International Electrotechnical Commission (IEC) IEC 62127-2. Edition 1.0. Ultrasonics - Hydrophones - Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz. Geneva: 2007
18. International Electrotechnical Commission (IEC) IEC 62127-3. Edition 1.0. Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz. Geneva: 2007
19. International Electrotechnical Commission (IEC) IEC 62306 Edition 1.0 Ultrasonics - Field characterisation - Test objects for determining temperature elevation in diagnostic ultrasound fields. Geneva: 2006
20. International Electrotechnical Commission (IEC) IEC 62359. Edition 2.0. Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. Geneva: 2010
21. International Electrotechnical Commission (IEC) IEC 62558. Edition 1.0. Ultrasonics - Real-time pulse-echo scanners - Phantom with cylindrical, artificial cysts in tissue-mimicking material and method for evaluation and periodic testing of 3D-distributions of void-detectability ratio (VDR). Geneva: 2011
22. International Electrotechnical Commission (IEC) IEC 62563-1 Ed.1: Medical Electrical Equipment - Medical image display systems - Part 1: Evaluation methods. Geneva: 2009
23. International Electrotechnical Commission (IEC) IEC 62736 Ed. 1.0 Quality Control of Diagnostic Medical Ultrasound Systems. Draft Geneva: 2011
24. Deutsche Industrie Norm (DIN): Sicherung der Bildqualität in röntgendiagnostischen Betrieben- Teil57: Abnahmeprüfung an Bildwiedergabegeräten; DIN V 6868-57 (2001-02).
25. American Association of Physicists in Medicne (AAPM) Real-time B-mode ultrasound quality control test procedures. 1998; www.aapm.org/pubs/reports/rpt- 65.pdf (accessed 26.6.2012)
26. Shaw A., Hekkenberg R. NPL Report: Standards to Support Performance Evaluation for Diagnostic Ultrasound Imaging Equipment. October 2007 ed Teddington National Physical Laboratory: 2007
27. National Health Service (NHS) Guidance Notes for the Acquisition and Testing of Ultrasound Scanners for use in the NHS Breast Screening Programme. NHSBSP Publ. #70 (April 2011). http://www.cancerscreening.nhs.uk/breastscreen/ publications/nhsbsp70.html (accessed 26.6.2012)
28. American Institute of Ultrasound in Medicine (AIUM) Routine Quality Assurance for Diagnostic Ultrasound Equipment. Report 2008. USA Laurel MD
29. Österr. Gesellschaft für Ultraschall in der Medizin (ÖGUM) Richtlinie über technische Basiserfordernisse für Ultraschall-Diagnostikgeräte (Sonographiegeräte) 2006. http://www.oegum.at/content/blogcategory/142/159/ (accessed 26.6.2012)
30. Mammo-Screening Referenzzentrums für technische Qualitä tssicherung (RefZQS) Richtlinie zur Anwendung von apparativen Prüfverfahren für Ultraschall-Diagnostikgeräte in der Mamma-Sonographie B-Bild, Task force Sono, Vers.1.0 (April 2011). Austria http://www.zmpbmt.meduniwien.ac. at/index.php?id=77&L=0 (accessed 26.6.2012)
31. Hangiandreou N. J., Stekel S. F., Tradup D. J. et al. Four-year experience with a clinical ultrasound Quality Control program. Ultrasound Med Biol: 2011; 37 1350 1357
32. Martensson M., Olsson M., Segall B. et al. High incidence of defective ultrasound transducers in use in routine clinical practice. Eur J Echocardiogr: 2009; 10 389 394
33. Moore G. W., Gessert A., Schafer M. The need for evidence-based quality assurance in the modern ultrasound clinical laboratory. Ultrasound: 2005; 13 158 162
34. Martensson M., Olsson M., Brodin L. A. Ultrasound transducer function: Annual testing is not sufficient. Eur J Echocardiogr: 2010; 11 801 805