New Standard for Foley Catheter Testing

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, and is described in ten 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

 

In addition to new strength tests, 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.

Contact the MET team to discuss your needs.