Balloon Dilation Catheters Tester

Refer to the standard YY 0285.4, ISO 10555 4 for balloon expansion catheter rated bursting pressure (RBP) test, balloon fatigue test, balloon pressure relief time test, balloon diameter and filling pressure relationship test. To meet the test needs of a multi-purpose machine, improve the utilization rate of equipment. Widely used in medical device manufacturers, testing institutions and other testing units.

 

Technical characteristics

★Large LCD test process, PVC operating panel, convenient and practical

★Multiple test modes fully meet the standard requirements

★Imported brand sensor system effectively ensures the accuracy of test results

★One key operation, automatic pressure test process display

★Equipped with micro printer, can print equipment serial number, sample batch number, experimental personnel, test results, test time and other complete test information

★Unique user hierarchical rights management function (4 levels) to ensure data integrity and standardization

★User-defined authority control, flexible development of all levels of authority, strictly limit the execution of various types of operations

★Perfect password protection scheme to limit illegal operations and ensure data traceability

★Adopt perfect record encryption storage form to ensure that each test information data is complete, safe and reliable

★System program with ISP online upgrade function, can provide personalized service

★Meet the requirements of GMP data local storage, automatic processing, statistical test data function

★Meet the requirements of Chinese GMP for data traceability to meet the needs of the pharmaceutical industry

 

Technical parameter

Measuring range	0～10.00MPa （Free setting）
Measurement error	±0.5%FS
Resolution	0.01MPa
Diameter resolution	0.01mm
User	50个（The user name is a combination of numbers, letters, or special symbols）
Data interface	RS232（Can connect to the user LIMS system）
Overall dimension	800mm×455×835mm(L*W*H)
Weight	103Kg
Environmental requirement
Operating temperature	10℃-50℃
Operating humidity	Up to 80%,  without any condensation
Working power supply	220V 50Hz

 

Reference standard

YY 0285.4 Intravascular catheters-Sterile catheters for single use - Part 4: Balloon dilating catheters

Appendix A: Balloon Bursting pressure rating (RBP) test

Appendix B: Balloon fatigue test without leakage and damage when filled

Appendix C: Balloon pressure relief time test

Appendix D: Test of the relationship between filling diameter and filling pressure  

ISO 10555 4:2013 ,MODIntravascular catheters- -Sterile and single-use catheters-Part 4 :Balloon dilatation catheters                   

 

Product configuration 

Main machine, micro printer, test fixture, constant temperature water tank