ASTM F2914-12(2018)
(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
3.1 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
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.
General Information
Relations
Standards Content (Sample)
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.
Designation:F2914 −12 (Reapproved 2018)
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 4. Procedure
1.1 This guide addresses the determination of appropriate
4.1 Shelf-life Establishment Model Introduction—The deci-
device attributes for testing as part of a shelf-life study for
sion flow chart (Fig. 1) assists study developers in selecting
endovascular devices. Combination and biodegradable devices
and justifying risk-appropriate test protocols for medical de-
(for example drug-devices, biologic devices or drug biologics)
vices to establish shelf life. The decision flowchart is intended
may require additional considerations, depending on their
toelicitquestionsandanappropriaterationalefortestingornot
nature.
testing a particular attribute during aging. The risk to the
patient as the device ages is one of the primary drivers. It is
1.2 This guide does not directly provide any test methods
for conducting shelf-life testing. recommended that all regulatory requirements and guidances
be considered during development of the shelf-life establish-
1.3 This standard does not purport to address all of the
ment test plan. See Fig. 1.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4.2 Question 1: “Could the device attribute change over
priate safety, health, and environmental practices and deter-
time?”:
mine the applicability of regulatory limitations prior to use.
4.2.1 Considerations in Evaluating Question 1—This ques-
1.4 This international standard was developed in accor-
tion must be addressed based on the device design character-
dance with internationally recognized principles on standard-
istics (and also in relation to the device being packaged,
ization established in the Decision on Principles for the
sterilized, shipped and stored).
Development of International Standards, Guides and Recom-
4.2.1.1 Consider attributes such as the following, for ex-
mendations issued by the World Trade Organization Technical
ample:
Barriers to Trade (TBT) Committee.
(1) Material Properties/Characterization—Composition;
2. Terminology
Mechanical Properties; Corrosion Resistance
(2) Dimensional and Functional Properties—Dimensions;
2.1 Definitions:
Surface Area; Foreshortening
2.1.1 endovascular device—device used to treat vascular
(3) Deliverability and Functionality—Balloon Fatigue;
disease from within the vessel.
Balloon Rated Burst; Bond Tensile Strength
2.1.2 product—final packaged and sterilized device with all
4.2.1.2 Various sources may provide sufficient evidence to
included components.
confirm that some specific attributes do not change over time
2.1.3 shelf life—the amount of real time that a fully pack-
for the application or that the change is not a risk to the patient.
aged (and sterilized, if applicable) product can be expected to
(1) Scientific literature.
remain in storage at specified conditions and maintain its
(2) Appropriate vendor publication.
critical performance properties.
(3) In-house research.
3. Significance and Use (4) Assessment of clinically accepted device.
4.2.1.3 When using such data to justify why certain attri-
3.1 The purpose of this guide is to provide a procedure for
butes may not require shelf-life testing, consider all differences
determining the appropriate attributes to evaluate in a shelf-life
between the subject device and the source of those data to
study for an endovascular device.
ensure applicability. For example, vendor literature may not
1
represent the actual use of the material by the device manu-
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
facturer. Additionally, further processing (for example, steril-
F04.30 on Cardiovascular Standards.
ization) may change the physical or chemical attribute(s) of the
Current edition approved Nov. 1, 2018. Published November 2018. Originally
material. Finally consider whether there are interactions
approved in 2012. Last previous edition approved in 2012 as F2914–12.
DOI:10.1520/F2914–12R18. (chemical or physical) that may impact your assessment.
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