ASTM F2475-20
(Guide)Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
SIGNIFICANCE AND USE
5.1 The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around, or on the human body, the benefits of these devices must outweigh the risks. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical, or biological properties of the device. This evaluation may include both a study of relevant experience with, and actual testing of, packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.
5.2 The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. When screening information is needed regarding the biocompatibility of the packaging, cytotoxicity testing from the supplier is typically performed.
SCOPE
1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or indirectly.
1.2 This guide does not apply to secondary or tertiary packaging materials.
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: F2475 − 20
Standard Guide for
Biocompatibility Evaluation of Medical Device Packaging
1
Materials
This standard is issued under the fixed designation F2475; 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 for materials, sterile barrier systems, and packaging sys-
4
tems
1.1 This guide provides information to determine the appro-
FDA Center for Devices and Radiological Health: 2016
priate testing for biocompatibility of medical device packaging
Biocompatibility Guidance: Use of International Standard
materials that have the potential to contact the patient directly
ISO 10993-1, "Biological evaluation of medical devices –
or indirectly.
Part 1: Evaluation and testing within a risk management
1.2 This guide does not apply to secondary or tertiary
process" (June 16, 2016)
packaging materials.
3. Terminology
1.3 This standard does not purport to address all of the
3.1 Definitions—Forterminologyrelatedtobarriermaterials
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- for medical packaging see Terminology F17.
priate safety, health, and environmental practices and deter-
3.2 Definitions of Terms Specific to This Standard:
mine the applicability of regulatory limitations prior to use.
3.2.1 extent of contact—degree to which the packaged
1.4 This international standard was developed in accor-
device will contact the patient (refer to ISO 10993-1). When
dance with internationally recognized principles on standard-
referringtothepackaging,extentofcontactreferstothedegree
ization established in the Decision on Principles for the
to which the packaging will interact with the device. Degree of
Development of International Standards, Guides and Recom-
packaging contact (interaction) is related to the physical-
mendations issued by the World Trade Organization Technical
chemical nature of the packaging materials and the device, the
Barriers to Trade (TBT) Committee.
intended use of the device (which relates to the categorization
of contact with the body), and the extent to which the
2. Referenced Documents
packaging may negatively impact the contained device.
2
2.1 ASTM Standards: 3.2.2 packaging biocompatibility—inherent ability of a ma-
terial to protect against a chemical change in the packaged
F17 Terminology Relating to Primary Barrier Packaging
medical device that could result in an adverse response to the
2.2 Other Standards:
host in its intended application.
ISO 10993-1:2018 Biological evaluation of medical devices
3.2.3 packaging biocompatibility testing—series of chemi-
– Part 1: Evaluation and testing within a risk management
3
cal and biological tests that a material is subjected to in order
process
to determine the ability of the packaging material to protect
ANSI/AAMI/ISO 11607-1:2006(R2010) Packaging for ter-
against a chemical change in the packaged medical device that
minally sterilized medical devices – Part 1: Requirements
could result in an adverse response to the host in its intended
application.
3.2.4 sterile barrier system—minimum package that pre-
1
This guide is under the jurisdiction of ASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on vents ingress of microorganisms and allows aseptic presenta-
Chemical/Safety Properties.
tion of the product at the point of use.
Current edition approved Jan. 1, 2020. Published February 2020. Originally
approved in 2005. Last previous edition approved in 2011 as F2475 – 11. DOI:
4. Summary of Practice
10.1520/F2475-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1 Materials used in packaging are to be evaluated per
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
definedguidelines,suchasAAMI/ANSI/ISO11607.Theeffect
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from International Organization for Standardization (ISO), ISO
4
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Geneva, Switzerland, http://www.iso.org. 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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...
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: F2475 − 11 F2475 − 20
Standard Guide for
Biocompatibility Evaluation of Medical Device Packaging
1
Materials
This standard is issued under the fixed designation F2475; 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 to determine the appropriate testing for biocompatibility of materials (or packaging
materials) in sterile barrier systems used to contain a medical device.medical device packaging materials that have the potential
to contact the patient directly or indirectly.
1.2 This guide does not apply to secondary or tertiary packaging materials.
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 safety, health, and healthenvironmental practices and to 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. Referenced Documents
2
2.1 ASTM Standards:
F17 Terminology Relating to Primary Barrier Packaging
2.2 Other Standards:
ANSI/AAMI/ISO 11607 Packaging for Terminally Sterilized Medical Devices
ISO 10993-1:2009 10993-1:2018 Biological Evaluationevaluation of Medical Devicesmedical devices – Part 1: Evaluation and
3
Testingtesting within a risk management process
USP <1031>ANSI/AAMI/ISO 11607-1:2006(R2010) The Biocompatibility of Materials Used in Drug Containers, Medical
Devices, and ImplantsPackaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier
4
systems, and packaging systems
FDA – Center for Devices and Radiological Health: Required Biocompatability Training and Toxicology Profiles for Evaluation
of Medical Devices (#G95-1)2016 Biocompatibility Guidance: Use of International Standard ISO 10993-1, "Biological
evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (June 16, 2016)
3. Terminology
3.1 Definitions—For terminology related to barrier materials for medical packaging see Terminology F17.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 biocompatibility—the inherent ability of a material to remain biologically inert with the host in its intended application.
3.2.2 biocompatibility testing—the series of chemical and biological tests that a material is subjected to in order to determine
the ability of the material to remain biologically inert with the host in its intended application.
1
This guide is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on
Chemical/Safety Properties.
Current edition approved April 1, 2011Jan. 1, 2020. Published April 2011February 2020. Originally approved in 2005. Last previous edition approved in 20052011 as
F2475 – 05.F2475 – 11. DOI: 10.1520/F2475-11.10.1520/F2475-20.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.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
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F2475 − 20
3.2.1 extent of contact—the degree to which the packaged device will contact the patient (refer to ISO 10993-1 for levels of
contact of the device with the human body). 10993-1). When referring to the packaging, extent of contact refers to the degree to
which the packaging will interact with the device. Degree of packaging contact (interaction) is related to the physical
...
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