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Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
Automaticky přeložený název:
Standardní zkušební metody pro in vitro pulsatile Zkoušky cévní stenty
NORMA vydána dne 1.3.2013
Označení normy: ASTM F2477-07(2013)
Poznámka: NEPLATNÁ
Datum vydání normy: 1.3.2013
Kód zboží: NS-53962
Počet stran: 10
Přibližná hmotnost: 30 g (0.07 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
durability test, endovascular cardiology, fatigue test, interventional cardiology, intravascular device test, pressure control, pulsatile fatigue, stent durability, stent fatigue, stent test, strain control, vascular stent, ICS Number Code 11.040.25 (Syringes. Needles. Catheters)
1. Scope | ||||
1.1 These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant diametric distension levels by means of hydrodynamic pulsatile loading. This testing occurs on a stent test specimen that has been deployed into a mock (elastically simulated) vessel. The typical duration of this test is 10 years of equivalent use (at 72 beats per minute), or at least 380 million cycles. 1.2 These test methods are applicable to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents, polymeric stents, or biodegradable stents, although the application of this test method to those products is not precluded. 1.3 These test methods do not include recommendations for endovascular grafts (“stent-grafts”) or other conduit products commonly used to treat aneurismal disease or peripheral vessel trauma or to provide vascular access, although some information included herein may be applicable to those devices. 1.4 These test methods are valid for determining stent failure due to typical cyclic blood vessel diametric distension. These test methods do not address other modes of failure such as dynamic bending, torsion, extension, crushing, or abrasion. 1.5 These test methods do not address test conditions for curved mock vessels. 1.6 These test methods do not address test conditions for overlapping stents. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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. 1.9 General
Caveat—
FDA Guidance Document 1545, Non-Clinical Tests and Recommended
Labeling for Intravascular Stents and Associated Delivery Systems,
(issued January 13, 2005) Available from Food and Drug
Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857,
http://www.fda.gov. This document available at
http://www.fda.gov/cdrh/ode/guidance/1545.pdf. ISO 7198: 1998(e), 8.10, Determination of Dynamic Compliance
Available from American National Standards Institute (ANSI), 25 W.
43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org. |
Poslední aktualizace: 25.04.2025 (Počet položek: 2 197 372)
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