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Standard Test Method for Coring Testing of Huber Needles
Přeložit název
NORMA vydána dne 1.10.2016
Označení normy: ASTM F3212-16
Poznámka: NEPLATNÁ
Datum vydání normy: 1.10.2016
Kód zboží: NS-667234
Počet stran: 10
Přibližná hmotnost: 30 g (0.07 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
core, Huber needle, medical device, non-coring needle,, ICS Number Code 11.040.30 (Surgical instruments and materials)
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. |
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1. 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. |
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2. Referenced Documents | ||
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