DTO332-C Catheter Dynamic Fracture Strength Test Tester

A fully implantable intravenous device (TotallyImplantableVenousAccessDevices, TIVAD), also known as an infusion port, is a long-term central venous infusion pathway
.

In 1982, Niederhuber reported surgical incision infusion port implantation at MDAnderson Cancer Center.
In 1992, Morris used percutaneous puncture technology to complete the implantation of intravenous infusion ports under X-ray guidance, which significantly improved the success rate of TIVAD implantation, and this technology has been widely used
since then.

Dynamic Fracture Strength Test Test Standard: YY0332-2011 Implantable Drug Delivery Device YY/T 0285.
6-2020 Intravascular Catheters Disposable Sterile Catheters Part 6 Subcutaneous Implantable Drug Delivery Device ISO 10555-6:2015 Intravascular Catheters -Sterile and Single-use catheters- Part 6: Subcutaneous implanted ports dynamic fracture strength test instrument: DTO332-C dynamic fracture strength tester, mainly used to determine the physical characteristics of the dynamic fracture strength performance of medical catheters, is one of the important means to identify the dynamic fracture strength performance of
medical catheters.

Dynamic breaking strength test principle: The dynamic breaking strength test
should be carried out at 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.

YY/T 0285.
6-2020 is consistent with 524 in YY0332-2011, and there is no non-conformance in the historical test data
.

The test parameters required here are "should be stretched in the direction of flow until the catheter elongation is 10%, or the maximum tensile force is 5N to take the first arrival, repeat 100,000 times"
.

The tensile force index is consistent with the minimum peak tensile force requirement at the junction between the infusion port and the catheter in IS010555-6, and the term was discussed at the beginning of the development of the standard, but considering that there are still differences between the two tests, the dynamic fracture strength is more to investigate the ability of the implanted patient to tolerate stretching of each joint during exercise, so this indicator is still included in
the YY0285.
6 standard.

DTO332-C Dynamic Fracture Strength Tester Technical Parameters Programmable Controller: PLC+ARM Instrument Operation Interface: Chinese Simplified/English Touch Screen: 7-inch K600+core/Dot Matrix 65 colors 800*480 Resolution Loading force: 0.
1N~30.
00N, error is not more than ±0.
5% Nominal Specifications: All specifications Arbitrary input test times: 1 time -200000 times Arbitrary set test frequency: Use a frequency test condition of 1Hz ±0.
2Hz at the catheter connection of the drug delivery device: Stretch the catheter to 10% elongation or 5N to take the first arriver (elongation and force values can be set by software) 3 samples can be tested at the same time, and the maximum sample length: 300mm
.