Medical Device Safety Testing Plan

Program-controlled medical leakage current tester RK7505y

Comprehensive testing plan for safety regulations of medical electrical equipment

Comprehensive testing plan for safety regulations of medical electrical equipment

Medical electrical equipment, as a special product in the electrical industry, requires relevant electrical safety testing. Generally, medical electrical equipment involved includes imaging (X-ray machines, CT scans, magnetic resonance, B-ultrasound), medical analyzers, as well as laser therapy machines, anesthesia machines, ventilators, extracorporeal circulation and other related medical devices. Medical device product research and development Targeted electrical safety testing and other related tests are required during the production process.

GB9706.1-2020 Medical Electrical Equipment

GB9706.1-2007/IEC6060 1-1-1988 Medical Electrical Equipment

UL260 1-2002 Medical Electrical Equipment

UL544-1988 Dental Medical Equipment

National medical electrical standards

Medical Device Safety Testing Plan

1、 Requirements for safety testing standards for medical devices

International regulations GB9706 1 (IEC6060-1) "Medical electrical equipment - Part 1: General safety requirements" and GB4793 1 (IEC6060-1) "Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements"

2、 Standard interpretation

1. GB9706 1 (IEC6060-1) "Medical electrical equipment - Part 1: General requirements for safety" stipulates that a voltage not exceeding half of the specified value should be applied at the beginning, and then the voltage should be increased to the specified value within 10 seconds. This value should be maintained at 1 minute, and then the voltage should be reduced to less than half of the specified value within 10 seconds. The specific voltage waveform is as follows:

voltage waveform

2. GB9706 1 (IEC6060-1) "Medical electrical equipment - Part 1: General safety requirements" stipulates that flashover or breakdown shall not occur during the test. Conventional voltage testers can only detect the "breakdown" defect of the tested equipment. If there is a flashover inside the tested electrical equipment, the leakage current is very small and there is no obvious sound and light phenomenon, which makes it difficult to determine. Therefore, medical pressure resistance has added an oscilloscope interface to observe the flashover phenomenon through the Li Shayu diagram.

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RK7505

Post time: Dec-04-2023
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