GB 9706.1-2020 Medical Device Safety Testing Items

1. Structural Inspection and Testing: Testing whether the structure of the equipment complies with the standard requirements, including the connection, fixation, and protection of each component.

2. Power Supply Voltage Adaptability: Testing whether the equipment can operate normally under the specified power supply voltage range.

3. InsULation Resistance: Testing whether the insulation material of the equipment meets the standard resistance requirements to avoid current leakage and electrical shock hazards.

4. Leakage Current: Testing whether the current of the equipment's casing or casing components in normal operation meets the standard to ensure user safety.

5. Dielectric Strength (Voltage Withstand Test): Testing whether the insulation material of the equipment can remain stable without breakdown under the specified voltage and time.

6. Abnormal Operation and Fault Conditions: Testing whether the equipment can shut down safely and notify the operator for repair under abnormal working conditions or faults.

7. Mechanical Strength: Testing whether the equipment structure can withstand the specified external force to avoid safety hazards caused by mechanical damage.

8. Stability: Testing whether the equipment can remain stable during normal operation without noticeable shaking or shifting.

9. Liquid Ingress: Testing whether the equipment can prevent liquid from entering the interior to avoid issues such as short circuits.

10. Cleaning and Disinfection: Testing whether the equipment can be easily cleaned and disinfected to maintain hygiene.

11. Temperature and Humidity: Testing whether the equipment can operate normally within the specified temperature and humidity range to avoid safety hazards caused by unsuitable conditions.

12. Grounding Test: Testing whether the grounding of the equipment meets the standard to avoid safety hazards caused by electric leakage.