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ASTM F 2394 : 2007 : R2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

03-01-2013

CONTAINED IN VOL. 13.01, 2017 Gives guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

1.1This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

1.2This guide covers the laboratory determination of the shear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system. The guide proposes a set of options to consider when testing stent securement. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. An example test apparatus is given in 7.1.

1.3This guide covers in vitro bench testing characterization only. Measured levels of securement and product design/process differentiation may be particularly influenced by selections of pre-test treatments, securement test type (for example, stent gripping method), and test endpoint. In vivo characteristics may also differ from in vitro results.

1.4This guide does not cover all possible pre-test treatments, stent securement tests, or test endpoints. It is intended to provide a starting point from which to select and investigate securement test options.

1.5This guide does not specify a method for mounting the stent onto the delivery system.

1.6The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

1.7This 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 requirements prior to use.

Committee
F 04
DocumentType
Guide
Pages
13
ProductNote
Reconfirmed 2013
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 3036 : 2013 Standard Guide for Testing Absorbable Stents
ASTM F 3206 : 2017 Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies

CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
EN 14299 : 2004 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS

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