ASTM F1980-16

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

SIGNIFICANCE AND USE
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.  
4.2 ISO 11607–1:2006, clause 6, states that “the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available.”  
4.3 Real time aging programs provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion.  
4.4 Conservative accelerated aging factors (AAFs) must be used if little is known about the sterile barrier system material being evaluated. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.  
4.5 When conducting accelerated aging programs for establishing expiry dating claims, it must be recognized that the data obtained from the study is based on conditions that simulate the effects of aging on the materials. The resulting creation of an expiration date or ...
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 on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 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 sterile barrier systems.  
1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.  
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 sterile barrier system validation, which include the machine process, the effects of the sterilization process, environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.  
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a definition of “environmental challenging.”  
1.7 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: 14-Sep-2016
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.50 - Package Design and Development

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 − 16
Standard Guide for
Accelerated Aging of Sterile Barrier Systems for Medical
1
Devices
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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This guide provides information for developing accel-
erated aging protocols to rapidly determine the effects, if any,
2. Referenced Documents
due to the passage of time on the sterile integrity of the sterile
2
2.1 ASTM Standards:
barrier system (SBS), as defined in ANSI/AAMI/ISO
D4332Practice for Conditioning Containers, Packages, or
11607–1:2006 and the physical properties of their component
Packaging Components for Testing
packaging materials.
E337Test Method for Measuring Humidity with a Psy-
1.2 Information obtained using this guide may be used to
chrometer (the Measurement of Wet- and Dry-Bulb Tem-
supportexpirationdateclaimsformedicaldevicesterilebarrier
peratures)
systems.
F17Terminology Relating to Flexible Barrier Packaging
F1327Terminology Relating to Barrier Materials for Medi-
1.3 The accelerated aging guideline addresses the sterile
3
cal Packaging (Withdrawn 2007)
barrier systems in whole with or without devices. The sterile
F2097Guide for Design and Evaluation of Primary Flexible
barrier system material and device interaction compatibility
that may be required for new product development or the Packaging for Medical Products
resulting evaluation is not addressed in this guide. 2.2 AAMI Standards:
ANSI/AAMI/ISO 11607–1: 2006,Packaging for Terminally
1.4 Real-time aging protocols are not addressed in this
4
Sterilized Medical Devices
guide; however, it is essential that real-time aging studies be
AAMITIR22–2007,GuidanceforANSI/AAMI/ISO11607,
performed to confirm the accelerated aging test results using
4
Packaging for Terminally Sterilized Medical Devices
the same methods of evaluation.
1.5 Methods used for sterile barrier system validation, 3. Terminology
which include the machine process, the effects of the steriliza-
3.1 Definitions—For general definitions of packaging for
tion process, environmental challenge, distribution, handling,
medicaldevices,seeANSI/AAMI/ISO11607.Forterminology
and shipping events, are beyond the scope of this guide.
related to barrier materials for medical packaging see Termi-
nology F17.
1.6 This guide does not address environmental challenging
that stimulates extreme climactic conditions that may exist in
3.2 Definitions of Terms Specific to This Standard:
the shipping and handling environment. Refer to Practice
3.2.1 accelerated aging (AA), n—storage of samples at an
D4332 for standard conditions that may be used to challenge
elevated temperature (T ) in order to simulate real time aging
AA
the sterile barrier system to realistic extremes in temperature
in a reduced amount of time.
and humidity conditions. See Terminology F1327 for a defini-
3.2.2 accelerated aging factor (AAF), n—an estimated or
tion of “environmental challenging.”
calculated ratio of the time to achieve the same level of
1.7 This standard does not purport to address all of the
physical property change as a sterile barrier system stored at
safety concerns, if any, associated with its use. It is the
real time (RT) conditions.
responsibility of the user of this standard to establish appro-
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
1
This guide is under the jurisdiction of ASTM Committee F02 on Primary Standards volume information, refer to the standard’s Document Summary page on
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on the ASTM website.
3
Package Design and Development. The last approved version of this historical standard is referenced on
Current edition approved Sept. 15, 2016. Published September 2016. Originally www.astm.org.
4
approved in 1999. Last previous edition approved in 2011 as F1980–07(2011). Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/F1980-16. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1980 − 16
3.2.3 accelerated aging temperature (T ), n—the elevated documented evidence to show a correlation between real time
AA
temperature at which the aging study is conducted, and it may and acc
...

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: F1980 − 07 (Reapproved 2011) F1980 − 16
Standard Guide for
Accelerated Aging of Sterile Barrier Systems for Medical
1
Devices
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. 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 provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to
the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1:2006 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 sterile barrier
systems.
1.3 The accelerated aging guideline addresses the sterile barrier systems in whole with or without devices. The sterile barrier
system material and device interaction compatibility that may be required for new product development or the resulting evaluation
is not addressed in this guide.
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 sterile barrier system validation, which include the machine process, the effects of the sterilization process,
environmental challenge, distribution, handling, and shipping events, are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulates extreme climactic conditions that may exist in the
shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile
barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327 for a definition of
“environmental challenging.”
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)
F17 Terminology Relating to Flexible Barrier Packaging
3
F1327 Terminology Relating to Barrier Materials for Medical Packaging (Withdrawn 2007)
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
2.2 AAMI Standards:
4
ANSI/AAMI/ISO 11607–1: 2006, Packaging for Terminally Sterilized Medical Devices
4
AAMI TIR 22–2007, Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices
1
This guide is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package
Design and Development.
Current edition approved Aug. 1, 2011Sept. 15, 2016. Published November 2011September 2016. Originally approved in 1999. Last previous edition approved in 20072011
as F1980 – 07.F1980 – 07(2011). DOI: 10.1520/F1980-07R11.10.1520/F1980-16.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1980 − 16
3. Terminology
3.1 Definitions—For general definitions of packaging for medical devices, see ANSI/AAMI/ISO 11607. For terminology related
to barrier materials for medical packaging see Terminology F17.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 accelerated aging (AA), n—storage of samples at an elevated temperature (T ) in order to simulate real time aging in a
AA
reduced amount of time.
3.2
...