Hypodermic and Other Needle Testing

Nov 1, 2018

By M.Turner

ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods is a standard which provides validation tests for a very specific size of needle. There are many other types of medical needle, some of which are not supported by consensus standards. In many cases, though, tests in ISO 7864 can be transferred.

With appropriate adjustment of the acceptance criteria the following tests are transferable to other needle applications:

Bond strength between hub and needle tube
Conical fitting
Determination of flow rate through the needle
Fragmentation test for medical needles
Freedom from defects
Lubricant application
Lumen patency
Needle point and other dimensions
Penetration force and drag force

There are specific standards for some other needle definitions, for example ISO 11608-2. MET also provides testing for these and conical fitting to ISO 80369.
Fragmentation and penetration force methods are also described in USP <382>

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