Catheter Testing | ISO 10555 & Other Catheter Tests
A catheter is a thin tube extruded from flexible medical grade materials and can serve a variety of functions in the field of medicine. Common uses include providing a means for drainage or injection of fluids by insertion into a body cavity, duct or vessel. Catheters are also used to permit access by surgical instruments. Catheters can be used to drain urine from the bladder, administer medication and assist in the measurement of blood pressure in an artery or vein. Through materials and processing modifications catheters can be customized for many different uses.
There are several international test standards that provide guidance for catheter testing. ISO 10555 (parts 1 – 5) is the major catheter testing standard. ASTM F623 tests the performance characteristics for Foley catheters. Kinking for single lumen catheters is tested under DIN EN 13686. ISO 594 is utilized for testing the conical fittings associated with catheter designs.
Capable of corrosion resistance testing, measuring force to break, measuring flow rates, verifying freedom from air and liquid leakage and many of the other tests within these accepted industry standards, DDL specializes in catheter testing for all types of applications and can also assist MDMs with any custom catheter testing needs.
ISO and ASTM Test Standards for Catheters
- ASTM F623 - Standard Performance Specification for Foley Catheter
- BS EN 1618 - Catheters other than intravascular catheters. Test methods for common properties
- DIN EN 13868 - Test methods for kinking of single lumen catheters and medical tubing
- ISO 594-1 - Conical fittings with 6% (Luer) taper - Part 1: General Requirements
- ISO 594-2 - Conical fittings with 6% (Luer) taper - Part 2: Lock Fittings
- ISO 10555 - Sterile, single-use intravascular catheters
Have a question about ISO 10555, ISO 594 or other catheter testing standards? Please contact us or Ask our Product & Material Testing Expert about your catheter testing needs.
You can also call us at 1-800-229-4235.
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