What is IEC 60601？
The full name is "Safety and Performance Standards for Medical Electrical Equipment". The test items include:
①Safety test: whether there are electric shock, fire, explosion, mechanical and other dangers. Test items include grounding, insulation, electromagnetic compatibility, electronic safety, etc.
②Electrical performance test: test whether the electrical performance of the equipment meets the requirements, including rated voltage, current, power, etc. Test items include power supply voltage, current, power factor, etc.
③Mechanical performance test: test whether the mechanical performance of the equipment meets the requirements, including strength, durability, stability, noise, etc.
④Biocompatibility test: test whether the biocompatibility of the equipment to the human body meets the requirements, including irritation and toxicity to the skin, mucous membranes, tissues, etc.
⑤Environmental condition test: Test whether the equipment can work normally under different environmental conditions, including temperature, humidity, air pressure, electromagnetic interference, etc.
⑥Software testing: test whether the software functions of the equipment meet the requirements, including software design, development, testing, verification, etc.