ASTM-F3212 › Standard Test Method for Coring Testing of Huber Needles
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Scope
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 and health practices and determine the applicability of regulatory limitations prior to use.
Significance and Use
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.
Keywords
core; Huber needle; medical device; non-coring needle;
To find similar documents by ASTM Volume:
13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)
To find similar documents by classification:
11.040.30 (Surgical instruments and materials Including surgical dressings, sutures, etc.)
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Medical Devices Regulations (Canada)
Document Number
ASTM-F3212-16R23
Revision Level
2016 R23 EDITION
Status
Current
Modification Type
New
Publication Date
Feb. 8, 2023
Document Type
Test Method
Page Count
10 pages
Committee Number
F04.33