EN IEC 63009-2019 pdf free.Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz (IEC 63009:2019).
The numbers given in brackets are the tolerances defining the range of acceptable values forthe results of either the type testing reference measurements specified in Clause 7 or theroutine measurements specified in Clause 8. If the published tolerance requirement cannot bemet,then the 95 % confidence level that is achievable should be reported. It shall then bedemonstrated that the reported value,when incorporated with the tolerance so as to producethe “worst case” value,remains within the range of acceptable values, as specified inIEC 60601-2-5.Please see guidance provided in Annex A of this document.
The ambient temperature range shall be specified for the parameters specified above. Therange of line voltages shall also be specified.
For ultrasonic physiotherapy equipment using a treatment head capable of operating atmore than one nominal value of acoustic working frequency,the parameters listed aboveshall be specified for each nominal value of acoustic working frequency.
ln addition,for ultrasonic physiotherapy equipment which can use an attachment head,the parameters listed above shall be specified for each combination of attachment head andtreatment head.
NOTE This document does not contain requirements relating to safety: these are covered in IEC 60601-2-5.Guidance on performance and safety can be found in Annex A of this document.
6Conditions of measurement and test equipment used for field measurements
6.1General All measurements undertaken in water shall be under approximately free-field conditions at atemperature of 22°C± 3°℃.
lf measurements are carried out at any other temperature, a test shall be undertaken to showthat the results,determined in accordance with 7.6 and 8.6,are not dependent on thetemperature at which the tests were undertaken.
Degassed water shall be used for the measurement of ultrasonic power,see 7.2.Measurement systems should be characterized to ensure no cavitation is present.
Degassed water is essential to avoid cavitation when the physiotherapy units are operated ator near full output power. Information on preparation of water suitable for measurements ofphysiotherapy output may be found in IEC TR 62781[8] and in [9].Even with degassed waterit is possible that cavitation may occur, especially at lower frequencies.Measurements shouldbe done in a manner to avoid cavitation as a general rule.
All measurements shall be made after the warm-up period specified by the manufacturer. f nosuch period is specified, a period of 30 min shall be used.
When making field measurements at lower powers or intensities and scaling upward withpower,care should be taken to ensure that the voltage supply itself is linear in the frequencyrange of interest and shows no hysteresis.EN IEC 63009 pdf download.