ASTM F3212 Test Fixture

Description

ASTM F3212 – Standard Test Method for Coring Testing of Huber Needles

ASTM F3212 covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access

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ASTM F3212 / Significance and Use

This test method determines whether Huber needles are designed and manufactured such that they will not produce a core during simulated

implantable port access.

If a needle produces a core during actual use, leaking of the implantable port may occur.

Also, the core may be flushed into the port’s reservoir and subsequently into the patient’s body.

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ASTM F3212 / Apparatus

Clamping Test Fixture, a clamping device which can hold a septum with nominal dimensions of 0.70 in. in diameter and 0.25 in. thick.

The clamping device is such that it restrains radial expansion of the septum under axial compression.

The compression force is specified when the compression plates are in contact.

The distance between the two compressive surfaces of the fixture plates after the clamping will be 0.213 in. Which results in nominal 15 % compression.

The clamping test fixture consists of six parts The septum is placed on the opening of the septum restrictor .

The septum restrictor with the septum is held between two clamps with three screws.

The screws must be tightened completely.

A polycarbonate cylinder  holds the clamping setup at a height that enables needle penetration while protecting the tester from any potential needle sticks.

Septum , a silicone disk 0.70 ± 0.01 in. İn diameter and 0.25 ± 0.01 in. thick.

The flat surfaces should be smooth with neither tool marks nor voids visible to the naked eye.

The septum is made of molded LSR (silicone) elastomeric material with a durometer hardness of 55 ± 5A (Test Method ASTM D2240).

Optical Microscope, capable of an optical magnification of at least 20×.

Stylet, a wire, not less than 70 % of inner diameter of the cannula, used to push through the needle to force out a possible core within the lumen.

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ASTM F3212 / Summary of Test Method

A silicone elastomeric disk (surrogate septum or just septum thereafter) is clamped into a specifically designed septum holder.

The test operator accesses the septum with a Huber needle in accordance with the needle manufacturer’s instructions for use, as if the septum

was an implantable port.

The lumen at the bevel is examined for the existence of a core, preferably before the needle is withdrawn.

This is categorized as a pass/fail test.

Existence of a core in the needle’s cannula is a failed result.

*** Before conducting ASTM F3212 , it is important to read the entire specification. Standards can be obtained from appropriate standard authorities.

 

***PARSROS  offers several types of grips and fixtures which will enable you to perform a variety of tests

  that are accurate and repeatable.