The medical device safety test items include the following:
1. Structural inspection and testing: test whether the structure of the equipment meets the requirements of the standard, including the connection, fixation, and protection of various components.
2. Power supply voltage adaptability: test whether the equipment can work normally under the power supply voltage within the specified range.
3. Insulation resistance: test whether the resistance value of the insulating material of the equipment meets the requirements of the standard to avoid dangers such as current leakage and electric shock.
4. Leakage current: test whether the current of the shell or shell parts of the equipment meets the standard requirements under normal working conditions, so as to ensure the safety of users.
5. Electrical strength (withstand voltage test): test whether the insulating material of the equipment can remain stable and not cause abnormal conditions such as breakdown under the action of the electric field under the specified voltage and specified time.
6. Abnormal working and fault conditions: test whether the equipment can be safely shut down under abnormal working conditions and fault conditions, and prompt the operator to repair.
7. Mechanical strength: test whether the structure of the equipment can withstand the specified external force to avoid potential safety hazards caused by mechanical damage.
8. Stability: Test whether the equipment can remain stable under normal working conditions without obvious shaking and offset.
9. Liquid ingress: test whether the equipment can prevent liquid from entering the interior to avoid problems such as circuit short circuit.
10. Cleaning and disinfection: test whether the equipment can be easily cleaned and disinfected to keep the equipment clean and hygienic.
11. Temperature and humidity: test whether the equipment can work normally within the specified temperature and humidity range, so as to avoid potential safety hazards caused by temperature and humidity discomfort.
12. Grounding test: test whether the grounding of the equipment meets the requirements of the standard to avoid potential safety hazards caused by leakage and other reasons.
Medical electrical safety test plan
DELTA Instruments is a high-tech enterprise specializing in medical device testing equipment, analytical instruments, mold sales and non-standard customized equipment. The main products include: GB9706 series safety and reliability testing equipment, medical needle testing instruments, syringe testing instruments, surgical instrument testing instruments, protective products testing instruments, rehabilitation auxiliary equipment testing instruments, medical signal simulators, medical testing and analysis instruments, ultrasonic testing instruments, radiation testing instruments, various test motifs, customer demand customization services, etc. The products are mainly used in various medical device manufacturing enterprises, scientific research institutes, medical device inspection centers, rehabilitation auxiliary equipment inspection centers, product quality supervision and inspection institutes, medical metrology laboratories, disease control centers, occupational disease prevention and control institutes, entry-exit inspection and quarantine, medical sciences and tertiary hospitals and other fields.