None 【Relevant Standards】

Meet the testing of all leakage current items stipulated in GB9706.1-2020 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance” and all leakage current items specified in IEC 61010-1 (2001), IEC60950-1 (2005), IEC60335-1 (2001) + A1:2004 + A2:2006 for active medical device inspection;

[Meet the standard]: Meet the testing of all leakage current items stipulated in GB9706.1-2020 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance” and all leakage current items specified in IEC 61010-1 (2001), IEC60950-1 (2005), IEC60335-1 (2001) + A1:2004 + A2:2006 for active medical device inspection; 【Technical Parameters】: 1. Maximum rated current 20A; 2. It can be used to test leakage current without frequency weighting without connecting to external devices or devices, and continuously switch polarity. 3. The external pins of the device should be equipped with S1, S5, S7, S9, S10, S12, S13, S15 switch hardware interfaces for leakage current testing in GB9706.1-2020, which can be controlled on and off through the equipment software. The equipment needs to have GB9706.1-2020 built-in leakage current (including but not limited to ground leakage current, contact current, patient leakage current, patient auxiliary current) test program, and can choose the corresponding test program according to the type of application part (B TYPE, BF type, CF type), which can test the normal state of leakage current and the result of a single fault with one click. 4. 110% voltage application, automatic testing, at least 100 target devices can be stored; 5. Equipped with a full set of test wires, alligator clips, and shell probes.