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ASTM F2079-02

(Test Method)

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

SIGNIFICANCE AND USE
Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high recoil must be expanded to a greater diameter to achieve its final relaxed diameter than a stent having low recoil. Practically, excessive expansion of the vessel into which the stent is to be implanted may cause tissue damage resulting in a poor immediate result or poor long-term outcome. Stent recoil is affected by intrinsic properties of the material used to construct the stent and the specific geometric design of the stent; therefore, measuring stent recoil is an essential part of evaluating the design.
SCOPE
1.1 The purpose of this test is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed size to its postdeployed size by mechanical means. This test may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report.
1.2 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.

General Information

Status
Historical
Publication Date
09-May-2002
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 F2079-01 - Standard Test Method for Measuring Recoil of Balloon-Expandable Stents
Effective Date
10-May-2002
Replaced By
ASTM F2079-02(2008) - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
Effective Date
01-May-2008
Referred By
ASTM F3067-14(2021) - Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
Effective Date
10-May-2002
Referred By
ASTM F3036-21 - Standard Guide for Testing Absorbable Stents
Effective Date
10-May-2002

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ASTM F2079-02 - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable StentsASTM F2079-02 - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
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ASTM F2079-02 - Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
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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:F2079–02
Standard Test Method for
Measuring Intrinsic Elastic Recoil of Balloon-Expandable
1
Stents
This standard is issued under the fixed designation F 2079; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope outer diameter of the stent is remeasured in the same positions
at approximately the same location.
1.1 The purpose of this test method is to quantify the
percentage by which the diameter of a stent decreases from its
4. Significance and Use
expanded diameter while still on the delivery balloon to its
4.1 Minimal stent recoil is a desirable feature of a stent
relaxed diameter after deflating the balloon.This test method is
because it minimizes the maximum diameter to which a stent
appropriate for stents manufactured from a material that is
must be expanded to achieve its final relaxed diameter.Astent
plastically deformed when the stent’s diameter is increased
having a high recoil must be expanded to a greater diameter to
from its predeployed size to its postdeployed size by mechani-
achieve its final relaxed diameter than a stent having low
cal means. This test method may be performed in air at room
recoil.Practically,excessiveexpansionofthevesselintowhich
temperatureunlessthereisaknowntemperaturedependenceof
the stent is to be implanted may cause tissue damage resulting
the material, in which case, the temperature at which the test is
in a poor immediate result or poor long-term outcome. Stent
conducted shall be stated in the report.
recoil is affected by intrinsic properties of the material used to
1.2 This standard does not purport to address all of the
construct the stent and the specific geometric design of the
safety concerns, if any, associated with its use. It is the
stent; therefore, measuring stent recoil is an essential part of
responsibility of the user of this standard to establish appro-
evaluating the design.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
5. Apparatus
2. Terminology 5.1 Ameans to inflate with noncompressible fluid, typically
water, the delivery balloon on which the stent is mounted. The
2.1 Definitions:
means used must be capable of achieving the pressure required
2.1.1 labeled diameter, n—the nominal deployed size of a
to maintain the expanded diameter of the stent until it can be
stent as indicated on its manufacturer’s label.
measured and may include a device to monitor pressure.
2.1.2 stent recoil, n—theamount,expressedasapercentage,
5.2 A means to measure the outer diameter of the stent
by which the diameter of a stent changes from the expanded
without deforming the stent. Typically, a calibrated optical
diameter measured with the stent on the inflated delivery
system, which does not require contact with the stent, is used.
balloon to the final value measured after deflating the balloon.
The resolution of the measurement system shall be 0.01 mm or
3. Summary of Test Method better. The accuracy of the system shall be 2 % of reading or
better.
3.1 A sample device representative of product that will be
marketed is either premounted or mounted on the delivery
6. Sampling, Test Specimens, and Test Units
balloon at the time of use. The delivery balloon is inflated to
6.1 Unless otherwise justified, all samples selected for
the nominal expansion pressure indicated for the labeled stent.
testing should be taken from fully processed, clinical quality
The outer diameter of the stent is measured in two approxi-
product. It is not required that these devices undergo terminal
mately orthogonal rotational positions while the stent is still on
sterilization.Cosmeticrejectsorothernonclinicalsamplesmay
the inflated delivery balloon. The balloon is deflated and the
be used if the cause for rejection has been shown not to affect
stent recoil.
6.2 The number of specimens tested for each unique stent
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
geometry should be sufficient to meet sampling requirements
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
for desired specification limits. In general, a minimum of ten
F04.30 on Cardiovascular Standards.
specimens is recommended. If a single stent geometry is
Current edition approved May 10, 2002. Published July 2002. Originally
published as F 2079 – 01. Last previous edition F 2079 – 01. intended to be used for more than one labeled diameter, recoil
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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SIGNIFICANCE AND USE
4.1 Minimal stent recoil is a desirable feature of a stent because it minimizes the maximum diameter to which a stent must be expanded to achieve its final relaxed diameter. A stent having a high recoil must be expanded to a greater diameter to achieve its final relaxed diameter than a stent having low recoil. Practically, excessive expansion of the vessel into which the stent is to be implanted may cause tissue damage resulting in a poor immediate result or poor long-term outcome. Stent recoil is affected by intrinsic properties of the material used to construct the stent and the specific geometric design of the stent; therefore, measuring stent recoil is an essential part of evaluating the design.
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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).  
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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.  
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SCOPE
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1.5 This guide does not specify a method for mounting the stent onto the delivery system.  
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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
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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