ISO 20495:2018 pdf free
ISO 20495:2018 pdf free.Traditional Chinese medicine – Skin electrical resistance measurement devices
electrode that is fixed on specific points of the patient (e.g hand-held or fixed on palm or forehead) for reference use, which is relatively fixed during detection
electrode that directly contacts acupuncture points or specific points of the patient’s body surface,constituting a pair of electrodes with an auxiliary electrode for resistance detection
root mean square (RMS) of maximum open-circuit voltage between the auxiliary electrode and the exploratory electrode in the detection electrical signal
RMS of maximum current between the auxiliary electrode and the exploratory electrode in detection of the electrical signal
device on the exploratory electrode or auxiliary electrode whose function is to control or display the applied force during detection, including an exploratory electrode with force switch
switch mounted in the exploratory electrode to reduce the error of detection result during use
accessible part that has electrical energy transmitting to the patient during detection of auxiliary electrode and exploratory electrode
Adjust the detection voltage to its maximum value. Measure the RMS value of the open-circuit output voltage between the auxiliary electrode and the exploratory electrode. The measured value shall not exceed 24 V.
The RMS value of the detection current shall not exceed 0,5 mA.Conformity is determined by carrying out the following test.
Adjust the detection current to its maximum value. Measure the RMS value of the short-circuit current between the auxiliary electrode and the exploratory electrode. For a device with short-circuit protection, the detection current is the RMS value of the maximum current that does not activate (trip) the short-circuit protection.
Conformity shall be confirmed if records provided by the manufacturer establish that the biocompatibility of the materials selected has been demonstrated. The biocompatibility of the contact part of the auxiliary electrode and the exploratory electrode intended to come into contact with the patient shall be assessed and documented according to the guidance and principles given in ISO 10993-1.ISO 20495 pdf free download.
