ASTM F2914-12
(Guide)Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
SIGNIFICANCE AND USE
The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.
SCOPE
1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example drug-devices, biologic devices or drug biologics) may require additional considerations, depending on their nature.
1.2 This guide does not directly provide any test methods for conducting shelf-life testing.
1.3 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.
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Designation:F2914 −12
Standard Guide for
Identification of Shelf-life Test Attributes for Endovascular
1
Devices
This standard is issued under the fixed designation F2914; 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 vices to establish shelf life. The decision flowchart is intended
toelicitquestionsandanappropriaterationalefortestingornot
1.1 This guide addresses the determination of appropriate
testing a particular attribute during aging. The risk to the
device attributes for testing as part of a shelf-life study for
patient as the device ages is one of the primary drivers. It is
endovascular devices. Combination and biodegradable devices
recommended that all regulatory requirements and guidances
(for example drug-devices, biologic devices or drug biologics)
be considered during development of the shelf-life establish-
may require additional considerations, depending on their
ment test plan. See Fig. 1.
nature.
1.2 This guide does not directly provide any test methods 4.2 Question 1: “Could the device attribute change over
time?”:
for conducting shelf-life testing.
4.2.1 Considerations in Evaluating Question 1—This ques-
1.3 This standard does not purport to address all of the
tion must be addressed based on the device design character-
safety concerns, if any, associated with its use. It is the
istics (and also in relation to the device being packaged,
responsibility of the user of this standard to establish appro-
sterilized, shipped and stored).
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4.2.1.1 Consider attributes such as the following, for ex-
ample:
2. Terminology
(1) Material Properties/Characterization—Composition;
2.1 Definitions: Mechanical Properties; Corrosion Resistance
(2) Dimensional and Functional Properties—Dimensions;
2.1.1 endovascular device—device used to treat vascular
disease from within the vessel. Surface Area; Foreshortening
(3) Deliverability and Functionality—Balloon Fatigue;
2.1.2 product—final packaged and sterilized device with all
Balloon Rated Burst; Bond Tensile Strength
included components.
4.2.1.2 Various sources may provide sufficient evidence to
2.1.3 shelf life—the amount of real time that a fully pack-
confirm that some specific attributes do not change over time
aged (and sterilized, if applicable) product can be expected to
for the application or that the change is not a risk to the patient.
remain in storage at specified conditions and maintain its
(1) Scientific literature.
critical performance properties.
(2) Appropriate vendor publication.
(3) In-house research.
3. Significance and Use
(4) Assessment of clinically accepted device.
3.1 The purpose of this guide is to provide a procedure for
4.2.1.3 When using such data to justify why certain attri-
determining the appropriate attributes to evaluate in a shelf-life
butes may not require shelf-life testing, consider all differences
study for an endovascular device.
between the subject device and the source of those data to
4. Procedure ensure applicability. For example, vendor literature may not
represent the actual use of the material by the device manu-
4.1 Shelf-life Establishment Model Introduction—The deci-
facturer. Additionally, further processing (for example, steril-
sion flow chart (Fig. 1) assists study developers in selecting
ization) may change the physical or chemical attribute(s) of the
and justifying risk-appropriate test protocols for medical de-
material. Finally consider whether there are interactions
(chemical or physical) that may impact your assessment.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
4.2.1.4 In order for testing to be applicable, the testing must
Surgical Materials and Devices and is the direct responsibility of Subcommittee
be conducted on articles that are representative of the final
F04.30 on Cardiovascular Standards.
device(thatis,utilizingthesamesterilizationmethodanddose,
Current edition approved Jan. 15, 2012. Published February 2012. DOI:10.1520/
F2914–12. dimensions,material,processingconditions,andpackaging).If
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2914−12
FIG. 1Device Aging Shelf-life Establishment Flow Chart
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F2914−12
test articles are not identical, provide appropriate justification used to answer this question. However, since risk analysis
for applicability of the te
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