The FDA perspective on pre-clinical testing for high intensity focused ultrasound devices

AIP Conference Proceedings

Volumn 829, Issue , 2006, Pages 595-598

  Harris, Gerald R ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

High intensity focused ultrasound; Medical device regulation

Indexed keywords

EID: 33845403509     PISSN: 0094243X     EISSN: 15517616     Source Type: Conference Proceeding    
DOI: 10.1063/1.2205543     Document Type: Conference Paper

References (4)

1. IEC 61846, Ultrasonics - Pressure pulse lithotripters - Characteristics of fields, Geneva: International Electrotechnical Commission, 1998.
2. IEC 60601-2-36, Particular requirements for the safety of equipment for extracorporeally induced lithotripsy, Geneva: International Electrotechnical Commission, 1997.
3. IEC 61689, Ultrasonics - Physiotherapy systems - Performance requirements and methods of measurement in the frequency range 0.5 MHz to 5 MHz, Geneva: International Electrotechnical Commission, 1996.
4. IEC 60601-2-5, Particular requirements for the safety of ultrasonic physiotherapy equipment, Geneva: International Electrotechnical Commission, 2000.