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next medical design, LLC offers laboratory services according to ISO, EN and ASTM standards as well as FDA Guidance Documents to confirm your product’s performance or benchmark analysis. The testing preparation, performance and reporting follows the guidelines of GLP and ISO13485.
These examples are for catheter, sheath, guidewire and needle products:
Small-bore connectors for liquids and gases in healthcare applications (ISO 80369-3, Enfit; ISO 80369-6, NRfit; ISO 80369-7, Luers; ISO 594-1/-2, Conical fittings with a 6% Luer taper)
Test for tensile properties (EN 1618)
Force at break (ISO 10555-1, ISO 11070)
Kinking test of tubing (EN 13868)
Test for security of connectors / Determination of strength of unions (EN 1618, ISO 10555-5)
Test for determining the security of fit of a drainage funnel (EN 1616)
Test for strength of union of core wire and coil of guide wire / union of coil and safety wire (ISO 11070)
Test for freedom from leakage and damage on inflation (Balloon Dilatation Catheters) (ISO 10555-4)
Test of bond between hub and needle tube (ISO 7864)
Patency of needle lumen (ISO 7864)
Limits for acidity or alkalinity (ISO 7864, ISO 7886-1)
Syringe performance and flow characteristics (ISO 7886-2)
Hypodermic needles: Penetration Testing (DIN 13097)
Mechanical test for verifying non-interconnectable characteristics of small-bore connectors (ISO 80369-1)
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications (AAMI/CN3:2014, ISO 80369-3)
Performance Testing of Huber Needles for Coring of Port Septa (Journal of Medical Devices, Sep. 2010, Vol. 4 / 031008-1)
Testing of stainless steel needle tubing for the manufacture of medical devices (ISO 9626)
Custom test procedures and fixtures for your unique product requirements
Metrology
We are continually expanding our laboratory capabilities and services. Please inquire if your product requires tests not found on this abridged list!
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