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ASTM F3212-16(2023)

Historical Reaffirmation

Standard Test Method for Coring Testing of Huber Needles

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1.1 This test method covers the qualitative measurement of Huber-type needles’ potential to remove septum material during implantable port access (1).2

1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


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

5.2 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.

SDO ASTM: ASTM International
Document Number F3212
Publication Date Feb. 1, 2023
Language en - English
Page Count 10
Revision Level 16(2023)
Supercedes
Committee F04.33
Publish Date Document Id Type View
Oct. 1, 2016 F3212-16 Revision
Feb. 1, 2023 F3212-16R23 Reaffirmation