References - Mcube CUBEscan BioCon-900S Operator's Manual

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CUBEScan BioCon-900S Operator's Manual

12 REFERENCES

AIUM: Medical Ultrasound Safety, American Institute of Ultrasound in Medicine, Laurel, MD, 1994.
AIUM: Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How
Manufactures Should Specify Acoustic Output Data, Revision 1, American Institute of Ultrasound in
Medicine, Laurel, MD, 2008.
AIUM/NEMA: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3.
NEMA Standards Publication UD 2-2004; American Institute of Ultrasound in Medicine, Laurel, MD;
National Electrical Association, Rosslyn, VA; 2004b.
Health Canada: "Guidelines for the safe use of diagnostic ultrasound," Cat. H46-2/01-255E, Ministry of
Public Works and Government Services Canada, 2001.
Health Canada: Medical Devices Regulations SOR/98-282
MDD 93/42/EEC, Medical Device, Office for the Official Publications of the European Communities, 2003.
IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential
Performance, International Electrotechnical Commission, 2012.
UL 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential
Performance, Underwriter Laboratories Inc, 2012.
CSA C22.2 No. 601.1B-90, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance, Canadian Standards Association, 2012.
IEC 60601-2-37, Medical electrical equipment – Part 2-37: Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment, International Electrotechnical Commission, 2007.
ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing with in a risk
management process, 2009.
FDA Guidance: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers, 2008
FDA Guidance: General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002.
Woo Sung Hong, Sun Young Ham, Tong-Wook Kim, Jeong-Seok Seo, Sang-Kuk Yang. Usefulness of a
Sonographic Bladder Scan for Uroflowmetry and the Evaluation of the Anxiety Level Associated with
Uroflowmetry. The Korean Journal of Urology 2007:48(06):633-637
Chung B, Lee T, Yang J H. The Diagnostic Value of Portable Bladder Volume Measurement (BVMS) with
Real Bladder Image in the Measurement of Bladder Volume According to the Different Angling of
Transducer. The Korean Journal of Urology 2006:47(06):1320-1326
Bodker B, Lose G. Postoperative urinary retention in gynecologic patients. Int Urogenecol J Pelvic Floor
Dsyfunct 2003;14:94-97
McNaughton-Collins M, Barry MJ. Managing patients with lower urinary tract symptoms suggestive of
benign prostatic hyperplasia. Am J Med 2005;118:1331-9
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