ISO 21291:2019 pdf free
ISO 21291:2019 pdf free.Traditional Chinese medicine – Therapeutic fumigation devices
The device shall have an over-temperature protection function at the steam outlet. When the temperature exceeds that specified by the manufacturer, heating of the decoction shall automatically stop and a corresponding auditory alarm signal and/or visual alarm signal shall be produced as specified in IEC 60601-1-8.
Conformity is checked by the following test:Place a thermometer and the temperature-sensing element of the steam outlet temperature-sensing unit into a constant-temperature water tank, and steadily increase the temperature in the tank until the over-temperature (±5 % of the manufacturer’s specified maximum value) protection function is triggered. Record the thermometer’s temperature and compare it with the value of over-temperature specified by the manufacturer.
Place a thermometer and the temperature-sensing element of the skin temperature-sensing unit into a constant-temperature tank, and steadily increase the temperature until the over-temperature (±5 % of the manufacturer s specified maximum value) protection is triggered.
Put the capsule temperature-sensing unit into a constant temperature water tank and steadily increase the temperature from the minimum to the maximum temperature specified by the manufacturer.Throughout the heating process, the error between displayed temperature value of the device and the actual temperature value of the constant-temperature water tank shall conform with the requirements.Temperature shall be set in accordance with the manufacturer’s instructions. Maximum, middle and minimum temperatures shall be set and tested separately. For each test, select five testing points that are evenly distributed within the treatment capsule. Once the stabilization time specified by the manufacturer has passed, 20 min to 30 min of continuous testing is performed. The temperature at each testing point during the all-time period shall meet the requirements.
The device should have an emergency stop function which can turn off the heating unit and steam output unit in accordance with IEC 60601-1:2005/AMD1:2012. This function cannot be automatically restored. The actuator for the emergency stop function shall be installed in a position that is easily visible and accessible to the user and the operator. The actuator for the emergency stop function shall be coloured red.ISO 21291 pdf free download.
