Release time：2023-03-30
Medical diagnosis, measurement and treatment equipment using AC power supply may cause leakage current due to improper grounding and electrical insulation, which may expose patients and even medical staff to the risk of electric shock, burns, internal organ damage and arrhythmia. So do a good jobMedical device shellInsulation work.
1. The equipment shall be manufactured and sealed to prevent contact with live parts and parts that may be live in a single fault state. If the bulb can be replaced without tools, it must be ensured to prevent contact with the live parts of the lamp when loading and unloading the bulb.
2. The position or size of any hole on the top cover of the medical device shell shall ensure that the test rod with a diameter of 4 mm and a length of 100 mm will not touch live parts when it is freely and vertically suspended in the access hole throughout its length.
3. When the handle, knob, control lever, etc. are removed, the conductor part of the operating mechanism of the control device can be touched. When the open circuit test voltage is not greater than 50V AC and the test current is not less than 1a, the resistance measured to the protective grounding terminal should not be greater than 0.2 Ω; Or it should be isolated from live parts by adopting a method of 17g in GB 9706.1-2007.
4. If the components with line voltage above 25V AC or 60V DC in the shell of the medical device cannot be disconnected from the power supply through the external main switch or the plug device that can be pulled out at any time, additional covers shall be used for protection, so that contact can be prevented even after the shell is opened, or when the spaces are separated and arranged, the "live" mark shall be clearly marked.
5. In order to prevent contact with live parts, the shell must be removed only with tools, otherwise an automatic device should be used when opening or removing the shell, so that these parts are not used.
6. When the device has a preset controller, it can be adjusted by the user with tools during normal use. The hole opened for adjusting these control devices shall be designed so that the adjusting tool cannot contact the basic insulation or any live parts in the hole, or any parts isolated from the grid power supply part only through the basic insulation but without grounding protection.
