Testing guideline for medical measuring devices on ultrasonic physiotherapy equipment in Thailand

The testing guideline of medical measuring devices on ultrasonic physiotherapy equipment is published in Thailand, which is conducted under a collaborative project between the ultrasound laboratory of the National Institute of Metrology, Thailand (NIMT) and the department of medical sciences, and the department of health service support, ministry of public health. This project has been carried out to develop the reference procedure for the acceptance testing or periodic testing of the therapeutic ultrasound, which meet the requirements from the authorities in Thailand. This procedure is created to avoid the devices damage to patient injury as well as mistreatment and to ensure the new devices work properly as the requirement of specification for the safe use. Also, this is to develop transfer standard devices for ensuring the accurate calibration of ultrasonic physiotherapy in clinical use. The guideline provides characteristic of the three main elements, which are the qualitative tests, the electrical safety tests and the quantitative tests. The verification of quantitative tests can be divided into three parts, which are the ultrasonic output power, timer and stimulator voltage and current. The ultrasound power meter (UPM) is used to determine the actual power output of ultrasonic physiotherapy, which shall be within ±30% of the device indication. For the timer checking, the ultrasonic physiotherapy is determined a timer setting of 1, 5 and 10 minutes at maximum output with the accuracy within ±10%. Finally, the stimulator voltage or current must be measured in case the working of ultrasonic physiotherapy has included the electrical stimulation section. The measured output can be expected to be within ±10%.