Which catheters can the Dynamic Fracture Strength Tester detect?

The Dynamic Fracture Strength Tester DTO332-C recently issued the "Guiding Opinions of the Comprehensive Department of the State Food and Drug Administration on Strengthening the Grading Supervision of Medical Device Production and Operation" issued in September 2022, which clarified the catalogue
of key regulatory varieties for medical device production.

Neurological and cardiovascular surgical instruments - cardiovascular interventional instruments products include contrast catheters, catheter guides, central venous catheters, perfusion catheters, balloon dilation catheters, contrast balloons, blocking balloons, thrombotic suction catheters, manufactory peripheral catheters, catheter catheters, catheter sheaths, microcatheters, etc.
are in the catalogue of key regulatory varieties of medical device production, and the State Food and Drug Administration will strengthen the supervision of such product manufacturers, and the quality of catheters should be strictly controlled
.

The instruments required for the quality testing of catheters are DTO332-C dynamic fracture strength tester, LL0285-C catheter flow tester, XL0461-C pipeline leakage tester, BP0285-C static pressure burst tester, GLL0285-D intravascular catheter dynamic injection flow and pressure tester, GLL0285-D intravascular catheter power injection flow and pressure tester, XL0489-C drainage system component leakage tester, YY0339-C catheter vacuum residue/leakage tester, YY0540-C guide wire bending performance tester, DZ0461-C duct airflow resistance tester, DTO332-C dynamic fracture strength tester, balloon reliability tester, firmness separation force tester, catheter strength tester, etc
.

Dynamic fracture strength tester is an efficient testing equipment
for national inspection of product performance of manufacturers.

It is mainly used to determine the physical characteristics of the dynamic fracture strength performance of medical catheters, and is one of the important means to identify the dynamic breaking strength performance of
medical catheters.

The testing standards for the dynamic fracture strength tester are based on: YY 0332-2011 Implantable drug delivery device YY/T 0285.
6-2020 Intravascular catheter Disposable sterile catheter Part 6 Subcutaneous implantable drug delivery device ISO 10555-6:2015 Intravascular catheters -Sterile and single-use catheters- Part 6: Subcutaneousimplanted ports
。
The principle and experimental method of the dynamic fracture strength tester should be tested with a frequency of 1Hz + 02Hz at each connection of the catheter of the drug delivery device
.

Stretching should be performed in the flow direction until the catheter elongation is 10%, or the maximum tensile force is 5N, take the first to arrive, and repeat 100,000 times
.

During the test, no components should break or rupture
.

If the catheter and the injection seat are split, they should also meet the above requirements after being connected according to the instructions for
use.

According to the principle and test method of the dynamic fracture strength tester, we know that the dynamic fracture strength performance of the catheter products in the category of neural and cardiovascular surgical instruments - cardiovascular interventional instruments can be detected by the instrument, while balloon products need to use testing equipment
such as balloon reliability testers.

Note that the dynamic fracture strength tester can only detect the dynamic breaking strength of the catheter, if you need to test other physical properties, you need to use other testing instruments
.

The above content is originally compiled by Wesa Technology, I hope it will be helpful to
you.