ASTM F2394-07(2017)

Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

SIGNIFICANCE AND USE
4.1 The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site.  
4.2 This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests and test endpoints to measure stent securement (displacement distances and dislodgment forces).  
4.3 This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios.  
4.4 This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs.  
4.5 This guide may be of use for developing a test for meeting parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability.  
4.6 This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.
SCOPE
1.1 This 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.  
1.2 This 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.  
1.3 This 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.  
1.4 This 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.  
1.5 This guide does not specify a method for mounting the stent onto the delivery system.  
1.6 The 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.  
1.7 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 requirements prior to use.  
1.8 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.

General Information

• Status: Historical
• Publication Date: 31-Aug-2017
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.30 - Cardiovascular Standards

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2394 − 07 (Reapproved 2017)
Standard Guide for
Measuring Securement of Balloon Expandable Vascular
1
Stent Mounted on Delivery System
This standard is issued under the fixed designation F2394; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This guide provides guidance for the design and devel-
responsibility of the user of this standard to establish appro-
opment of pre-test treatments, tests, and test endpoints to
priate safety and health practices and determine the applica-
measure stent securement of pre-mounted, unsheathed,
bility of regulatory requirements prior to use.
balloon-expandable stent delivery systems. This guide is in-
1.8 This international standard was developed in accor-
tended to aid investigators in the design, development, and in
dance with internationally recognized principles on standard-
vitro characterization of pre-mounted, unsheathed, balloon-
ization established in the Decision on Principles for the
expandable stent delivery systems.
Development of International Standards, Guides and Recom-
1.2 This guide covers the laboratory determination of the
mendations issued by the World Trade Organization Technical
shear force required to displace or dislodge a balloon-
Barriers to Trade (TBT) Committee.
expandable endovascular stent mounted on a delivery system.
The guide proposes a set of options to consider when testing
2. Referenced Documents
stent securement. The options cover pre-test treatments, pos- 2
2.1 ASTM Standards:
sible stent securement tests, and relevant test endpoints. An
E1169 Practice for Conducting Ruggedness Tests
example test apparatus is given in 7.1.
E1488 GuideforStatisticalProcedurestoUseinDeveloping
1.3 This guide covers in vitro bench testing characterization and Applying Test Methods
only. Measured levels of securement and product design/
2.2 Other Documents:
process differentiation may be particularly influenced by selec-
ISO 10555-1 Sterile Sterile Sterile, Single-use Intravascular
3
tions of pre-test treatments, securement test type (for example,
Catheters—Part 1: General Requirements
stent gripping method), and test endpoint. In vivo characteris-
Quality System Regulation, Part VII Dept. Health and Hu-
tics may also differ from in vitro results.
man Services, Food and Drug Administration, 21 CFR
Part 820 Medical Devices; Current Good Manufacturing
1.4 This guide does not cover all possible pre-test
4
Practice; Final Rule. Federal Register, October 7, 1996
treatments, stent securement tests, or test endpoints. It is
EN 14299 Non Active Surgical Implants—Particular Re-
intended to provide a starting point from which to select and
quirements for Cardiac and Vascular Implants—Specific
investigate securement test options.
5
Requirements For Arterial Stents, May 2004
1.5 This guide does not specify a method for mounting the
CDRH Guidance, Non-Clinical Tests and Recommended
stent onto the delivery system.
Labeling for Intravascular Stents andAssociated Delivery
6
Systems, January 13, 2005
1.6 The 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
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
system shall be used independently of the other. Combining
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
values from the two systems may result in non-conformance
Standards volume information, refer to the standard’s Document Summary page on
with the standard.
the ASTM website.
3
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
4
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
Surgical Materials and Devices and is the direct responsibility of Subcommittee www.access.gpo.gov.
5
F04.30 on Cardiovascular Standards. Available from British Standards Institute (BSI), 389 Chiswick High Rd.,
Current edition approved Sept. 1, 2017. Published September 2017. Originally London W4 4AL, U.K., http://www.bsi-global.com.
6
approved in 2004. Last previous edition approved in 2013 as F2394 – 07 (2013). Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
DOI: 10.1520/F2394-07R17. Rockville, MD 20857,. Http:/
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2394 − 07 (Reapproved 2013) F2394 − 07 (Reapproved 2017)
Standard Guide for
Measuring Securement of Balloon Expandable Vascular
1
Stent Mounted on Delivery System
This standard is issued under the fixed designation F2394; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This 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.
1.2 This 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.
1.3 This 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.
1.4 This 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.
1.5 This guide does not specify a method for mounting the stent onto the delivery system.
1.6 The 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.
1.7 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
requirements prior to use.
1.8 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E1169 Practice for Conducting Ruggedness Tests
E1488 Guide for Statistical Procedures to Use in Developing and Applying Test Methods
2.2 Other Documents:
3
ISO 10555-1 Sterile Sterile Sterile, Single-use Intravascular Catheters—Part 1: General Requirements
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.30
on Cardiovascular Standards.
Current edition approved March 1, 2013Sept. 1, 2017. Published March 2013September 2017. Originally approved in 2004. Last previous edition approved in 20072013
as F2394 – 07.F2394 – 07 (2013). DOI: 10.1520/F2394-07R13.10.1520/F2394-07R17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2394 − 07 (2017)
Quality System Regulation, Part VII Dept. Health and Human Services, Food and Drug Administration, 21 CFR Part 820
4
Medical Devices; Current Good Manufacturing Practice; Final Rule. Federal Register, October 7, 1996
EN 14299 Non Active Surgical Implants—Particular Requirements for Cardiac and Vascular Implants—Specific Requirements
5
For Ar
...