ASTM F1980-07
(Guide)Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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 D 4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F 1327 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
Relations
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F1980–07
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 2. Referenced Documents
2
1.1 This guide provides information for developing accel- 2.1 ASTM Standards:
erated aging protocols to rapidly determine the effects, if any, D4332 Practice for Conditioning Containers, Packages, or
due to the passage of time on the sterile integrity of the sterile Packaging Components for Testing
barrier system (SBS), as defined in ANSI/AAMI/ISO E337 Test Method for Measuring Humidity with a Psy-
11607–1:2006 and the physical properties of their component chrometer (the Measurement of Wet- and Dry-Bulb Tem-
packaging materials. peratures)
1.2 Information obtained using this guide may be used to F17 Terminology Relating to Flexible Barrier Packaging
supportexpirationdateclaimsformedicaldevicesterilebarrier F1327 Terminology Relating to Barrier Materials for Medi-
3
systems. cal Packaging
1.3 The accelerated aging guideline addresses the sterile F2097 GuideforDesignandEvaluationofPrimaryFlexible
barrier systems in whole with or without devices. The sterile Packaging for Medical Products
barrier system material and device interaction compatibility 2.2 AAMI Standards:
that may be required for new product development or the ANSI/AAMI/ISO11607–1:2006, PackagingforTerminally
4
resulting evaluation is not addressed in this guide. Sterilized Medical Devices
1.4 Real-time aging protocols are not addressed in this AAMI TIR 22–2007, Guidance for ANSI/AAMI/ISO
guide; however, it is essential that real-time aging studies be 11607, Packaging for Terminally Sterilized Medical De-
4
performed to confirm the accelerated aging test results using vices
the same methods of evaluation.
3. Terminology
1.5 Methods used for sterile barrier system validation,
which include the machine process, the effects of the steriliza- 3.1 Definitions—For general definitions of packaging for
medicaldevices,seeANSI/AAMI/ISO11607.Forterminology
tion process, environmental challenge, distribution, handling,
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:
3.2.1 accelerated aging (AA), n—storage of samples at an
the shipping and handling environment. Refer to Practice
D4332 for standard conditions that may be used to challenge elevated temperature (T ) in order to simulate real time aging
AA
in a reduced amount of time.
the sterile barrier system to realistic extremes in temperature
and humidity conditions. See Terminology F1327 for a defini- 3.2.2 accelerated aging factor (AAF), n—an estimated or
calculated ratio of the time to achieve the same level of
tion of “environmental challenging.”
1.7 This standard does not purport to address all of the physical property change as a sterile barrier system stored at
real time (RT) conditions.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible 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. Withdrawn. The last approved version of this historical standard is referenced
Current edition approved April 1, 2007. Published May 2007. Originally on www.astm.org.
4
approved in 1999. Last previous edition approved in 2002 as F1980–02. DOI: Available from theAmerican National Standards Institute, 25 W. 43rd St., 4th
10.1520/F1980-07. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
F1980–07
3.2.3 accelerated aging temperature (T ), n—the elevated 4.5 When conducting accelerated aging programs for estab-
AA
temperature at which the aging study is conducted, and it may lishingexpirydatingclaims,itmustberecognizedthatthed
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F 1980–02 Designation:F1980–07
Standard Guide for
Accelerated Aging of Sterile Medical Device
PackagesAccelerated Aging of Sterile Barrier Systems for
1
Medical 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
1.1This 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.
1.2Information obtained using this guide may be used to support expiration date claims for medical device packages.
1.3The 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.
1.1 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 inANSI/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
systemmaterialanddeviceinteractioncompatibilitythatmayberequiredfornewproductdevelopmentortheresultingevaluation
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.
1.5Methods 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
1.5 Methodsusedforsterilebarriersystemvalidation,whichincludethemachineprocess,theeffectsofthesterilizationprocess,
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
2.1 ASTM Standards:
D3078Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
2 2
D4169Practice for Performance Testing of Shipping Containers and Systems ASTM Standards:
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E337 Test Method for Measuring Humidity with a Psychrometer (The(the Measurement of Wet- and Dry-Bulb Temperatures)
1
ThisguideisunderthejurisdictionofASTMCommitteeF02onFlexibleBarrierMaterialsandisthedirectresponsibilityofSubcommitteeF02.60onMedicalPackaging.
´1
Current edition approved Jan. 10, 2002. Published March 2002. Originally published as F 1980–99. Last previous edition F 1980–99 . on Flexible Barrier Packaging and
is the direct responsibility of Subcommittee F02.50 on Package Design and Development.
CurrenteditionapprovedApril1,2007.PublishedMay2007.Originallyapprovedin1999.Lastpreviouseditionapprovedin2002asF1980–02.DOI:10.1520/F1980-07.
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.For Annual Book of ASTM Standards
, Vol 15.09.volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM Internat
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.