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.
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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
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
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2914−12 (2018)
FIG. 1Device Aging Shelf-life Establishment Flow Chart
F2914−12 (2018)
4.2.1.4 In order for testing to be applicable, the testing must attribute, resulting from aging, pose a significant risk to the
be conducted on articles that are representative of the final patient or clinician?” Risk analysis is an appropriate technique
device(thatis,utilizingthesamesterilizationmethodanddose, used to answer this question. However, since risk analysis
dimensions,material,processingconditions,andpackaging).If methodologies have yet to be standardized, there is no defini-
test articles are not identical, provide appropriate justification
tiverisklevelthatcanbeapplieduniversallyforalldevicesand
for applicability of the testing. parameters. It will be the responsibility of individual compa-
4.2.2 Justification Based upon Scientific Principles—When
nies to carefully develop the threshold for acceptable risk.
one considers whether an attribute should be included in a
4.3.1 Basis for Risk Assessment—The assessment of risk
shelf-life study, the first question is whether the attribute
related to a device attribute may be conducted using clinical
changes over time.There are several device attributes that may
history (in literature or privately held) or the complaint history
be driven by physical parameters of the device that would not
of a similar device used in a similar application. Additionally,
change over time and therefore will not require shelf-life
a scientific/medical argument might provide adequate informa-
testing. The assessment should be conducted using universal
tion to assess the risk.
scientific/physical principles. In cases where the assessment is
4.3.2 Risk Assessment Examples—The following examples
based on universal scientific/physical principal, appropriate
of risk assessment of selected attributes are for illustrative
references should be provided. In cases where justifications
purposes only; this guide cannot claim to address all circum-
may be less obvious, data to support the scientific/physical
stances and thus these examples should not be used to overly
rationale shall be generated. Tables 1 and 2 list two groups of
influence a company’s policies. When not expected to impact
device attributes with accompanying scientific rationale.
safety or performance, the scientific justification shall be
4.2.3 Justification Based upon Data—Scientific principles
documented in detail.
forsomedeviceattributes/requirementsarenotreadilyevident.
In such cases, one may generate data to support a rationale. It
5. Shelf-life Establishment Report
may be advantageous to conduct testing in a manner that
allows for the data to be applicable to various size devices. In 5.1 The report shall include a complete device description,
assumptions for device storage, and the device attributes
this case, it is important to translate the device attribute (such
as system flexibility) into the underlying size independent considered for testing in conducting a device aging shelf-life
establishment study. The decision to conduct testing or not for
scientific parameters (such as Young’s modulus). Testing is
then conducted to evaluate the stability of the core scientific each device attribute shall be reported. The rationale for why
testing of a specific device attribute was determined to not be
parameter. For each device attribute, more than one scientific
parameter may be necessary to demonstrate stability over the necessary (answered “no” to Questions 1 or 2) shall be
reported. The reported rationale shall provide sufficient detail
aging period. (For simplicity of the examples, only one test
parameter is illustrated in Table 3.) Each device attribute to convince a person with adequate engineering/scientific
experience. References supporting rationale to not conduct
should be evaluated to determine what scientific parameters
maybeaffectedbyagingandtheappropriatetestingtomitigate testing should be provided, as appropriate. When testing of a
each of those risks should then be conducted. The attributes specific device attribute was determined to be necessary
(answered“yes”toQuestions1and2),norationaleneedstobe
ev
...
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: F2914 − 12 (Reapproved 2018)
Standard Guide for
Identification of Shelf-life Test Attributes for Endovascular
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
to elicit questions and an appropriate rationale for testing or not
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
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2914 − 12 (2018)
FIG. 1 Device Aging Shelf-life Establishment Flow Chart
F2914 − 12 (2018)
4.2.1.4 In order for testing to be applicable, the testing must attribute, resulting from aging, pose a significant risk to the
be conducted on articles that are representative of the final patient or clinician?” Risk analysis is an appropriate technique
device (that is, utilizing the same sterilization method and dose, used to answer this question. However, since risk analysis
dimensions, material, processing conditions, and packaging). If
methodologies have yet to be standardized, there is no defini-
test articles are not identical, provide appropriate justification tive risk level that can be applied universally for all devices and
for applicability of the testing.
parameters. It will be the responsibility of individual compa-
4.2.2 Justification Based upon Scientific Principles—When nies to carefully develop the threshold for acceptable risk.
one considers whether an attribute should be included in a
4.3.1 Basis for Risk Assessment—The assessment of risk
shelf-life study, the first question is whether the attribute
related to a device attribute may be conducted using clinical
changes over time. There are several device attributes that may
history (in literature or privately held) or the complaint history
be driven by physical parameters of the device that would not
of a similar device used in a similar application. Additionally,
change over time and therefore will not require shelf-life
a scientific/medical argument might provide adequate informa-
testing. The assessment should be conducted using universal
tion to assess the risk.
scientific/physical principles. In cases where the assessment is
4.3.2 Risk Assessment Examples—The following examples
based on universal scientific/physical principal, appropriate
of risk assessment of selected attributes are for illustrative
references should be provided. In cases where justifications
purposes only; this guide cannot claim to address all circum-
may be less obvious, data to support the scientific/physical
stances and thus these examples should not be used to overly
rationale shall be generated. Tables 1 and 2 list two groups of
influence a company’s policies. When not expected to impact
device attributes with accompanying scientific rationale.
safety or performance, the scientific justification shall be
4.2.3 Justification Based upon Data—Scientific principles
documented in detail.
for some device attributes/requirements are not readily evident.
In such cases, one may generate data to support a rationale. It
5. Shelf-life Establishment Report
may be advantageous to conduct testing in a manner that
5.1 The report shall include a complete device description,
allows for the data to be applicable to various size devices. In
this case, it is important to translate the device attribute (such assumptions for device storage, and the device attributes
considered for testing in conducting a device aging shelf-life
as system flexibility) into the underlying size independent
scientific parameters (such as Young’s modulus). Testing is establishment study. The decision to conduct testing or not for
each device attribute shall be reported. The rationale for why
then conducted to evaluate the stability of the core scientific
parameter. For each device attribute, more than one scientific testing of a specific device attribute was determined to not be
necessary (answered “no” to Questions 1 or 2) shall be
parameter may be necessary to demonstrate stability over the
aging period. (For simplicity of the examples, only one test reported. The reported rationale shall provide sufficient detail
to convince a person with adequate engineering/scientific
parameter is illustrated in Table 3.) Each device attribute
should be evaluated to determine what scientific parameters experience. References supporting rationale to not conduct
may be affected by aging and the appropriate testing to mitigate testing should be provided, as appropriate. When testing of a
each of those risks should then be conducted. The attributes specific device attribute was determined to be necessary
evaluated must be conducted on samples that are representative (answered “yes” to Questions 1 and 2), no rationale
...
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: F2914 − 12 F2914 − 12 (Reapproved 2018)
Standard Guide for
Identification of Shelf-life Test Attributes for Endovascular
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
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.
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.
2. Terminology
2.1 Definitions:
2.1.1 endovascular device—device used to treat vascular disease from within the vessel.
2.1.2 product—final packaged and sterilized device with all included components.
2.1.3 shelf life—the amount of real time that a fully packaged (and sterilized, if applicable) product can be expected to remain
in storage at specified conditions and maintain its critical performance properties.
3. 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.
4. Procedure
4.1 Shelf-life Establishment Model Introduction—The decision flow chart (Fig. 1) assists study developers in selecting and
justifying risk-appropriate test protocols for medical devices to establish shelf life. The decision flowchart is intended to elicit
questions and an appropriate rationale for testing or not testing a particular attribute during aging. The risk to the patient as the
device ages is one of the primary drivers. It is recommended that all regulatory requirements and guidances be considered during
development of the shelf-life establishment test plan. See Fig. 1.
4.2 Question 1: “Could the device attribute change over time?”:
4.2.1 Considerations in Evaluating Question 1—This question must be addressed based on the device design characteristics
(and also in relation to the device being packaged, sterilized, shipped and stored).
4.2.1.1 Consider attributes such as the following, for example:
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 Jan. 15, 2012Nov. 1, 2018. Published February 2012November 2018. DOI:10.1520/F2914–12. Originally approved in 2012. Last previous edition
approved in 2012 as F2914–12. DOI:10.1520/F2914–12R18.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2914 − 12 (2018)
FIG. 1 Device Aging Shelf-life Establishment Flow Chart
F2914 − 12 (2018)
(1) Material Properties/Characterization—Composition; Mechanical Properties; Corrosion Resistance
(2) Dimensional and Functional Properties—Dimensions; Surface Area; Foreshortening
(3) Deliverability and Functionality—Balloon Fatigue; Balloon Rated Burst; Bond Tensile Strength
4.2.1.2 Various sources may provide sufficient evidence to confirm that some specific attributes do not change over time for the
application or that the change is not a risk to the patient.
(1) Scientific literature.
(2) Appropriate vendor publication.
(3) In-house research.
(4) Assessment of clinically accepted device.
4.2.1.3 When using such data to justify why certain attributes may not require shelf-life testing, consider all differences between
the subject device and the source of those data to ensure applicability. For example, vendor literature may not represent the actual
use of the material by the device manufacturer. Additionally, further processing (for example, sterilization) may change the
physical or chemical attribute(s) of the material. Finally consider whether there are interactions (chemical or physical) that may
impact your assessment.
4.2.1.4 In order for testing to be applicable, the testing must be conducted on articles that are representative of the final device
(that is, utilizing the same sterilization method and dose, dimensions, material, processing conditions, and packaging). If test
articles are not identical, provide appropriate justification for applicability of the testing.
4.2.2 Justification Based upon Scientific Principles—When one considers whether an attribute should be included in a shelf-life
study, the first question is whether the attribute changes over time. There are several device attributes that may be driven by
physical parameters of the device that would not change over time and therefore will not require shelf-life testing. The assessment
should be conducted using universal scientific/physical principles. In cases where the assessment is based on universal
scientific/physical principal, appropriate references should be provided. In cases where justifications may be less obvious, data to
support the scientific/physical rationale shall be generated. Tables 1 and 2 list two groups of device attributes with accompanying
scientific rationale.
4.2.3 Justification Based upon Data—Scientific principles for some device attributes/requirements are not readily evident. In
such cases, one may generate data to support a rationale. It may be advantageous to conduct testing in a manner that allows for
the data to be applicable to various size devices. In this case, it is important to translate the device attribute (such as system
flexibility) into the underlying size independent scientific parameters (such as Young’s modulus). Testing is then conducted to
evaluate the stability of the core scientific parameter. For each device attribute, more than one scientific parameter may be
necessary to demonstrate stability over the aging period. (For simplicity of the examples, only one test parameter is illustrated in
Table 3.) Each device attribute should be evaluated to determine what scientific parameters may be affected by aging and the
appropriate testing to mitigate each of those risks should then be conducted. The attributes evaluated must be conducted on samples
that are representative of the device; and the stability evaluation must be equal or greater than the anticipated shelf life. Some
hypothetical examples are printed in the remainder of this section.
4.3 Question 2: “Will the change have an impact on safety or performance?”—Once it has been determined that a device
attribute is likely to be affected by time and storage conditions, the second question to evaluate is whether the change poses a
possible risk to the patient or product performance. Another way of stating the question is: “Will a change in the device attribute,
resulting from aging, pose a significant risk to the patient or clinician?” Risk analysis is an appropriate technique used to answer
this question. However, since risk analysis methodologies have yet to be standardized, there is no definitive risk level that can be
applied universally for all devices and parameters. It will be the responsibility of individual companies to carefully develop the
threshold for acceptable risk.
4.3.1 Basis for Risk Assessment—The assessment of risk related to a device attribute may be conducted using clinical history
(in literature or privately held) or the complaint history of a similar device used in a similar application. Additionally, a
scientific/medical argument might provide adequate information to assess the risk.
TABLE 1 Example Attributes Typically Impacted by Aging
Device Attribute Scientific Principle
Nylon polymer catheter tensile at Aging of polymers can result in the breaking of chemical bonds and/or a reduction in polymer chain entanglement. Therefore
break this dynamic process needs to be assessed after defined shelf-life testing conditions.
Balloon rated burst
...
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