New Standard for Foley Catheter Testing
MET is providing full testing to ISO 20696, which replaces EN 1616 for Foley catheters.
Published in July 2018, ISO 20696 – Sterile urethral catheters for single use, replaces EN1616.
Full testing to the new standard is available from MET. It is more detailed than previous versions with some new tests and improved methods.
Test methods are described in 10 appendices:
A. Strength of catheter
B. Security of fit of connectors / drainage funnel
C. Balloon safety
D. Inflation lumen performance
E. Flow rate
F. Corrosion resistance
G. Kink stability
H. Peak tensile force
I. Deflation stability
J. Resistance to traction
There are new strength tests and the kink resistance test has been completely redeveloped. ASTM F623 -Standard Performance Specification for Foley Catheter- describes some complimentary and some overlapping protocols. Both documents require conditioning in simulated urine for 7 or 14 days prior to some studies.