Noninvasive surgery is one of the fastest growing areas of medical science. Doctors are using the “cath lab” more often in lieu of traditional surgery, in favor of the reduced risk and shorter recovery times. Innovative medical procedure proposals and incremental technology improvements are driving researchers to turn to International Organization for Standardization and ATSM standards for their product testing. Catheter researchers can look into ISO 10555 for high-quality testing procedures.
ISO 10555 defines tests for intravascular single use catheters. Catheter types that can be tested according to this standard include angiographic catheters, central venous catheters, balloon dilation catheters and over-needle peripheral catheters. ISO 10555 recommends testing for corrosion, force at break, liquid leakage under pressure and air leakage.
Testing procedure
The standard establishes the need to test each portion of the catheter, including each tube, hub, connector and junction. ISO 10555 asks for a measure of tensile force until a break occurs or until a junction separates. Typically, the load requirements are at 15 N (3 lbs) and test speed must be accurately controlled based on the sample length, up to a strain rate of 20 mm/min/mm strain rate.
With advanced experience in the biomedical field, we offer comprehensive solutions to test catheters in accordance to ISO 10555 standards. One of our more popular products used for ISO 10555 include the 220 Series Universal Test Machines. This machine is capable of exerting pressures at or below 5 kN with a relatively high stroke, perfect for elongating samples such as catheters. Another product that can be used to test ISO 10555 is the 100 Series Universal Test Machines. This machine exerts forces up to 10 kN and comes with an array of options for controllers, actuators and accessories. The vice grip has v-jaws meant for better gripping of round samples.
By means of our expertise and product inventory, we guarantee to help find the testing solution that is right for you. Give one of our experienced application engineers a call today for assistance with your testing plan and budget according to ISO 10555.
Related Applications and Standards
- How to Build a 510k Test Plan to Speed your Time to Market
- ISO 13485 How Our Test Machines Fit in your Manufacturing Process Validation
- Luer Testing in Accordance with ISO 80369 Standards
Recommended Test Machines
Forces up to 10 kN (2,250 lbf)
Low force tabletop systems
Modular series of five frame options with adjustable test space
Affordable testing option for tension, compression, bend, peel and much more
Forces up to 5 kN (1,125 lbf)
Low force tabletop systems
Tests at speeds up to 2,500 mm/min (100 in/min)
Best for high travel or high elongation test requirements
Recommended Accessories
Forces of 0.2 kN to 250 kN (45 lbf to 55 kip)
Adjustable air pressure
Forces of 1 kN to 300 kN (225 lbf to 67,500 lbf)
Low force tabletop systems
Modular series of five frame options with adjustable test space
Affordable testing option for tension
