ASTM F1980-02

Standard Guide for Accelerated Aging of Sterile Medical Device Packages

SCOPE
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to the passage of time and environmental effects on the sterile integrity of packages and the physical properties of their component packaging materials.
1.2 Information obtained using this guide may be used to support expiration date claims for medical device packages.
1.3 The accelerated aging guideline addresses the primary medical package in whole and does not address the package and product interaction or compatibility that may be required for new product development. Package and product compatibility and interactions should be addressed as a material analysis process before package design.
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation.
1.5 Methods used for package process validation, which include the machine process, the effects of the sterilization process, distribution, handling, and shipping events, are beyond the scope of this guide.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Jan-2002
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.50 - Package Design and Development

Relations

• Replaces: ASTM F1980-99e1 - Standard Guide for Accelerated Aging of Sterile Medical Device Packages
• Effective Date: 10-Jan-2002
• Replaced By: ASTM F1980-07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• Effective Date: 01-Apr-2007
• Referred By: ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
• Effective Date: 10-Jan-2002
• Referred By: ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
• Effective Date: 10-Jan-2002
• Referred By: ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 10-Jan-2002

Standards Content (Sample)

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:F1980–02
Standard Guide for
1
Accelerated Aging of Sterile Medical Device Packages
This standard is issued under the fixed designation F1980; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope D4169 Practice for Performance Testing of Shipping Con-
tainers and Systems
1.1 This guide provides information for developing accel-
D4332 Practice for Conditioning Containers, Packages, or
erated aging protocols to rapidly determine the effects, if any,
Packaging Components for Testing
due to the passage of time and environmental effects on the
E337 Test Method for Measuring Humidity with a Psy-
sterileintegrityofpackagesandthephysicalpropertiesoftheir
chrometer (the Measurement of Wet- and Dry-Bulb Tem-
component packaging materials.
peratures)
1.2 Information obtained using this guide may be used to
F88 Test Method for Seal Strength of Flexible Barrier
support expiration date claims for medical device packages.
Materials
1.3 The accelerated aging guideline addresses the primary
F1140 Test Methods for Internal Pressurization Failure
medical package in whole and does not address the package
Resistance of Unrestrained Packages for Medical Applica-
and product interaction or compatibility that may be required
tions
for new product development. Package and product compat-
F1327 TerminologyRelatingtoBarrierMaterialsforMedi-
ibility and interactions should be addressed as a material
cal Packaging
analysis process before package design.
F1585 Guide for Integrity Testing of Porous Barrier Medi-
1.4 Real-time aging protocols are not addressed in this
cal Packages
guide; however, it is essential that real-time aging studies be
F1608 TestMethodforMicrobialRankingofPorousPack-
performed to confirm the accelerated aging test results using
aging Materials (Exposure Chamber Method)
the same methods of evaluation.
F1929 Test Method for Detecting Seal Leaks in Porous
1.5 Methods used for package process validation, which
Medical Packaging by Dye Penetration
include the machine process, the effects of the sterilization
2.2 AAMI Standards:
process, distribution, handling, and shipping events, are be-
ANSI/AAMI/ISO 11607, Packaging for Terminally Steril-
yond the scope of this guide.
3
ized Medical Devices
1.6 This standard does not purport to address all of the
AAMI TIR 17-1997, Radiation Sterilization—Material
safety concerns, if any, associated with its use. It is the
3
Qualification
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
3. Terminology
bility of regulatory limitations prior to use.
3.1 Definitions—For general definitions of packaging for
2. Referenced Documents medical devices seeANSI/AAMI/ISO 11607. For terminology
2 related to barrier materials for medical packaging see Termi-
2.1 ASTM Standards:
nology F1327.
D3078 TestMethodforDeterminationofLeaksinFlexible
3.2 Definitions of Terms Specific to This Standard:
Packaging by Bubble Emission
3.2.1 accelerated aging (AA), n—storage of samples at an
elevated temperature (T ) in order to simulate real time aging
AA
in a reduced amount of time.
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible 3.2.2 accelerated aging factor (AAF), n—an estimated or
Barrier Materials and is the direct responsibility of Subcommittee F02.50 on
calculated ratio of the time to achieve the same level of
Package Design and Development.
physical property change as a package stored at real time (RT)
Current edition approved Jan. 10, 2002. Published March 2002. Originally
e1
conditions.
published as F1980–99. Last previous edition F1980–99 .
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
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the ASTM website. Floor, New York, NY 10036.
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F1980–02
3.2.3 accelerated aging temperature (T ), n—the elevated 5. Apparatus
AA
temperature at which the aging study is conducted, and it may
5.1 Room (or Cabinet) of such size that sample containers
bebasedontheestimatedstoragetemperature,estimatedusage
or packages may be individually exposed to circulating air at
temperature, or both.
the temperature and relative humidity chosen.
3.2.4 accelerated aging time (AAT), n—the lengt
...