Electrophysiological mapping catheters are important tools for collecting electrophysiological signals in the heart cavity and calibrating the structure in the heart cavity during cardiac electrophysiological examinations. The test methods in its instruction manual usually cover multiple aspects to ensure the safety, effectiveness, and reliability of the catheter. The following are the test methods compiled according to the YY/T 1519-2017 standard and related materials:

I. External marking inspection
Visually inspect the outer packaging of the electrophysiological mapping catheter and the catheter itself to confirm whether the following information is marked:

Catheter outer diameter
Catheter effective length
Production batch number
Expiration date (or a combination of production date and effective use period)
Sterilization method
Disposable use mark
II. Physical performance inspection
Appearance inspection: Under normal or corrected force, use a magnifying glass (magnification 2.5 times) to check whether the catheter and its handle part (if applicable) are clean and free of impurities, processing defects, and burrs.
Breaking force test: Determine the breaking force of each test section of the catheter according to the method in Appendix B of YY0285.1-2004 to ensure that it meets the standard requirements.
Adjustment mechanism controllability test: If the catheter has an adjustment mechanism, the controllability of the adjustment mechanism shall be tested according to the method specified by the manufacturer to ensure that it meets the requirements specified by the manufacturer.
Bending fatigue test: Perform the bending fatigue test according to the method in Appendix A of YY0778-2010 or the method specified by the manufacturer. After the test, check whether the outer surface of the catheter has no obvious damage and meets the relevant requirements.
Radiographic detectability test: The manufacturer shall specify appropriate test methods and conditions to test the radiographic detectability of the catheter.
III. Electrical performance test
DC resistance measurement: Use a high-precision multimeter to measure the DC resistance between the electrode and the corresponding core pin in the catheter handle jack or the tail wire jack to ensure that it meets the requirements specified by the manufacturer.
Insulation resistance measurement: Under the condition of DC 500V, measure the insulation resistance between different electrodes, between the outer surface of the catheter and the corresponding core pin of any electrode, and between different core pins of the tail wire to ensure that they are not less than 5MΩ.
IV. Chemical performance test
Reducing substance test: Test according to the method of 5.2.2 in GB/T14233.1-2008 to ensure that the difference in the consumption of potassium permanganate solution (0.002mol/L) between the test solution and the blank control solution of the same batch with the same volume does not exceed 2.0mL.
Heavy metal test: Test according to the method of 5.6.2 in GB/T14233.1-2008 to ensure that the color of the test solution does not exceed the standard control solution with a mass concentration of β(Pb+)=1μg/mL.
Acidity and alkalinity test: Test according to the method of 5.4.1 in GB/T14233.1-2008 to ensure that the pH of the test solution is compared with the blank control solution of the same batch, and the pH difference does not exceed 1.5.
Evaporation residue test: In 50ml of test solution, the total mass of non-volatile matter should not exceed 2mg.
Ethylene oxide residue test (if applicable): Ensure that the ethylene oxide residue is not more than 10μg/g.
UV absorbance test: When the test solution is in the wavelength range of 250nm~320nm, the absorbance should not be greater than 0.1.
Corrosion resistance test: After the corrosion test, the metal parts of the catheter should not have corrosion marks.
V. Biological performance test
Sterility test: The sterilized catheter should be sterile.
Pyrogen test: The catheter should be pyrogen-free.
Cytotoxicity test: The cytotoxic reaction is not greater than level 1.
Intradermal reaction test: The difference between the average score of the test sample and the solvent control should be no more than 1.0.
Delayed hypersensitivity test: There should be no delayed hypersensitivity.
Blood compatibility test:
Hemolysis: The hemolysis rate should be less than 5%.
Thrombosis: The thrombosis grade should be no more than level 2, and there is no significant difference between the test sample and the control group.
Coagulation: After the partial thromboplastin time test, it should be a non-endogenous coagulation pathway activator or a very slight activator.
Acute systemic toxicity test: The part of the catheter in contact with the blood circuit or blood should have no acute systemic toxicity.
VI. Safety requirements inspection
The catheter should comply with GB9706.1-2007 General safety requirements for medical electrical equipment.

VII. Instruction manual inspection
The instruction manual should clearly indicate the specifications or models of the equipment suitable for use with the catheter and contain necessary precautions, possible adverse reactions, and countermeasures.

In summary, the inspection methods in the instruction manual for the electrophysiological mapping catheter cover multiple aspects to ensure the safety, effectiveness, and reliability of the catheter. In actual operation, the inspection and use should be strictly in accordance with the instructions and relevant standards.