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ASTM F2394-07

(Guide)

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

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

SIGNIFICANCE AND USE
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.
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).
This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios.
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.
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.
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 .
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.
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.

General Information

Status
Historical
Publication Date
14-Jul-2007
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.30 - Cardiovascular Standards
Current Stage
Ref Project

Relations

Replaces
ASTM F2394-04 - Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System
Effective Date
15-Jul-2007
Replaced By
ASTM F2394-07(2013) - Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
Effective Date
01-Mar-2013
Referred By
ASTM F3036-21 - Standard Guide for Testing Absorbable Stents
Effective Date
15-Jul-2007
Referred By
ASTM F3206-17 - Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular Therapies
Effective Date
15-Jul-2007

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ASTM F2394-07 - Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery SystemASTM F2394-07 - Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
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ASTM F2394-07 - Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
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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
StandardGuide 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This guide provides guidance for the design and devel-
E1169 Practice for Conducting Ruggedness Tests
opment of pre-test treatments, tests, and test endpoints to
E1488 GuideforStatisticalProcedurestoUseinDeveloping
measure stent securement of pre-mounted, unsheathed,
and Applying Test Methods
balloon-expandable stent delivery systems. This guide is in-
2.2 Other Documents:
tended to aid investigators in the design, development, and in
ISO 10555-1 Sterile Sterile Sterile, Single-use Intravascular
vitro characterization of pre-mounted, unsheathed, balloon-
3
Catheters—Part 1: General Requirements
expandable stent delivery systems.
Quality System Regulation, Part VII Dept. Health and Hu-
1.2 This guide covers the laboratory determination of the
man Services, Food and Drug Administration, 21 CFR
shear force required to displace or dislodge a balloon-
Part 820 Medical Devices; Current Good Manufacturing
4
expandable endovascular stent mounted on a delivery system.
Practice; Final Rule. Federal Register, October 7, 1996
The guide proposes a set of options to consider when testing
EN 14299 Non Active Surgical Implants—Particular Re-
stent securement. The options cover pre-test treatments, pos-
quirements for Cardiac and Vascular Implants—Specific
5
sible stent securement tests, and relevant test endpoints. An
Requirements For Arterial Stents, May 2004
example test apparatus is given in 7.1.
CDRH Guidance, Non-Clinical Tests and Recommended
Labeling for Intravascular Stents andAssociated Delivery
1.3 This guide covers in vitro bench testing characterization
6
Systems, January 13, 2005
only. Measured levels of securement and product design/
7
MAUDE Database
process differentiation may be particularly influenced by selec-
tions of pre-test treatments, securement test type (for example,
3. Terminology
stent gripping method), and test endpoint. In vivo characteris-
3.1 Definitions:
tics may also differ from in vitro results.
3.1.1 balloon expandable stent, n—a stent that is expanded
1.4 This guide does not cover all possible pre-test
at the treatment site by a balloon catheter. The stent material is
treatments, stent securement tests, or test endpoints. It is
plastically deformed by the balloon expansion such that the
intended to provide a starting point from which to select and
stent remains expanded after deflation of the balloon.
investigate securement test options.
3.1.2 crimp, v—tosecurethestentonthedeliverysystemby
radially compressing and plastically deforming the stent onto
1.5 This guide does not specify a method for mounting the
the balloon.
stent onto the delivery system.
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
responsibility of the user of this standard to establish appro-
Standards volume information, refer to the standard’s Document Summary page on
priate safety and health practices and determine the applica-
the ASTM website.
bility of regulatory requirements prior to use.
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,
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and www.access.gpo.gov.
5
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available from British Standards Institute (BSI), 389 Chiswick High Rd.,
F04.30 on Cardiovascular Standards. London W4 4AL, U.K., http://www.bsi-global.com.
6
Current edition approved July 15, 2007. Published August 2007. Originally Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
approved in 2004. Last previous edition approved in 2004 as F2394 – 04. DOI: Rockville, MD 20857,. Http://www.fda.gov/cdrh/ode/guidance/1545.pdf.
7
10.1520/F2394-07. Http://www.fda.gov/cdrh/maude.html.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2394 − 0
...

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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).  
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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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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5.3 The forces applied to the intervertebral body fusion assemblies may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different intervertebral body fusion device assemblies.  
5.4 Since the environment may affect the dynamic performance of intervertebral body fusion device assemblies, dynamic testing in a saline environment may be considered. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is desired, the investigator should consider testing in a saline environmental bath at 37 °C (for example, 0.9 g NaCl per 100 mL water) at a rate of 1 Hz or less. A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37 °C could also be used with adequate justification.  
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SCOPE
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1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies.  
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1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface.  
1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4).  
1.6 Guidelines are established for measuring displacements, determining the yield force or moment, and evaluating the stiffness and strength of the intervertebral body fusion device assemblies.  
1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is ...

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ASTM ISO/ASTM51939-17(2022)(Practice)
Standard Practice for Blood Irradiation Dosimetry

SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).9  
4.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.  
4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
4.9 Proper ...
SCOPE
1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.  
1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and  60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.  
1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.  
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539).  
1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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 ...

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ASTM A908-03(2019)(Specification)
Standard Specification for Stainless Steel Needle Tubing

ABSTRACT
The specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial application. An electric furnace or other similar primary melting process with or without degassing or refining may be used. Needle tubing shall be made by the seamless or welded and drawn process and shall be furnished in the hard-drawn temper condition. Tension tests shall be made to meet the required tensile requirements.
SCOPE
1.1 This specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial applications.  
1.2 In general, needle tubing describes small-diameter tubing with outside diameters (ODs) in the range of 0.008 to 0.203 in. (0.2 to 5.2 mm) with nominal wall thicknesses in the range of 0.002 to 0.015 in. (0.05 to 0.4 mm). Needle tubing gages are normally 6 through 33.  
1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.4 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.

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