ASTM F2475-11
(Guide)Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
SIGNIFICANCE AND USE
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, these devices must do no harm. 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.
The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.
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.
1.2 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 to determine the applicability of regulatory limitations prior to use.
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Designation: F2475 − 11
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 3.2.2 biocompatibility testing—the series of chemical and
biological tests that a material is subjected to in order to
1.1 This guide provides information to determine the appro-
determine the ability of the material to remain biologically
priate testing for biocompatibility of materials (or packaging
inert with the host in its intended application.
materials) in sterile barrier systems used to contain a medical
3.2.3 extent of contact—the degree to which the packaged
device.
device will contact the patient (refer to ISO 10993-1 for levels
1.2 This standard does not purport to address all of the
of contact of the device with the human body). When referring
safety concerns, if any, associated with its use. It is the
tothepackaging,extentofcontactreferstothedegreetowhich
responsibility of the user of this standard to establish appro-
the packaging will interact with the device. Degree of packag-
priate safety and health practices and to determine the
ing contact (interaction) is related to the physical-chemical
applicability of regulatory limitations prior to use.
nature of the packaging materials and the device, the intended
use of the device (levels of contact with the body), and the
2. Referenced Documents
extent to which the packaging may negatively impact the
2
2.1 ASTM Standards:
contained device.
F17 Terminology Relating to Flexible Barrier Packaging
3.2.4 sterile barrier system—minimum package that pre-
2.2 Other Standards:
vents ingress of microorganisms and allows aseptic presenta-
ANSI/AAMI/ISO 11607 Packaging for Terminally Steril-
tion of the product at the point of use.
ized Medical Devices
ISO 10993-1:2009 Biological Evaluation of Medical De-
4. Summary of Practice
vices – Part 1: Evaluation and Testing
USP <1031> The Biocompatibility of Materials Used in
4.1 Materials used in packaging are to be evaluated per
Drug Containers, Medical Devices, and Implants
defined guidelines, such as AAMI/ANSI/ISO 11607. Addi-
FDA – Center for Devices and Radiological Health: Re-
tional biocompatibility testing for packaging materials may be
quired Biocompatability Training and Toxicology Profiles
required based on the extent of material contact with the
for Evaluation of Medical Devices (#G95-1)
contained medical device, the subsequent degree to which the
packaged device (product) will contact the patient, and the
3. Terminology
intendeduseofthedevice.Whenselectingtheappropriatetests
3.1 Definitions—Forterminologyrelatedtobarriermaterials for biological evaluation of medical devices, the chemical
for medical packaging see Terminology F17. characteristics of the device materials, as well as the nature,
degree, frequency and duration of the device’s exposure to the
3.2 Definitions of Terms Specific to This Standard:
body must be considered. Similar testing may be considered
3.2.1 biocompatibility—the inherent ability of a material to
for medical packaging, when there is not a history of safe use
remain biologically inert with the host in its intended applica-
of packaging materials for their intended sue or there may be
tion.
a question as to whether the packaging may negatively impact
the contained device. Guidelines for biocompatibility verifica-
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
tion of medical device packaging are based on FDA guidance
Barrier Packaging and is the direct responsibility of Subcommittee F02.15 on
(Memorandum #G-95), ANSI/AAMI/ISO 10993-1 and USP
Chemical/Safety Properties.
<1031> The Biocompatibility of Materials Used in Drug
Current edition approved April 1, 2011. Published April 2011. Originally
Containers, Medical Devices, and Implants.While the scope of
approved in 2005. Last previous edition approved in 2005 as F2475 – 05. DOI:
10.1520/F2475-11.
these standards does not directly apply to medical device
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
packaging, use of them will address the intent of ISO 11607.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
The reader is advised to consult these standards in determin-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. ing which tests apply for a given packaging application. All
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959.
...
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:F2475–05 Designation: F2475 – 11
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.
1.2 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 to determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F1327TerminologyRelatingtoBarrierMaterialsforMedicalPackaging17 TerminologyRelatingtoFlexibleBarrierPackaging
2.2 Other Standards:
ANSI/AAMI/ISO 11607 Packaging for Terminally Sterilized Medical Devices
ISO 10993-1:20039 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing
USP <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants
FDA – Center for Devices and Radiological Health: Required Biocompatability Training and Toxicology Profiles for
Evaluation of Medical Devices (#G95-1)
3. Terminology
3.1 Definitions—For terminology related to barrier materials for medical packaging see Terminology F1327F17.
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.
3.2.3 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). 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-chemical nature of the
packaging materials and the device, the intended use of the device (levels of contact with the body), and the extent to which the
packaging may negatively impact the contained device.
3.2.4 sterile barrier system—minimum package that prevents ingress of microorganisms and allows aseptic presentation of the
product at the point of use.
4. Summary of Practice
4.1 Materials used in packaging are to be evaluated per defined guidelines, such as AAMI/ANSI/ISO 11607. Additional
biocompatibilitytestingforpackagingmaterialsmayberequiredbasedontheextentofmaterialcontactwiththecontainedmedical
device, the subsequent degree to which the packaged device (product) will contact the patient, and the intended use of the device.
When selecting the appropriate tests for biological evaluation of medical devices, the chemical characteristics of the device
materials, as well as the nature, degree, frequency and duration of the device’s exposure to the body must be considered. Similar
testing may be considered for medical packaging, when there is not a history of safe use of packaging materials for their intended
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible Barrier MaterialsPackaging and is the direct responsibility of Subcommittee F02.15 on
Chemical/Safety Properties.
Current edition approved April 1, 2005. Published May 2005. DOI: 10.1520/F2475-05.
CurrenteditionapprovedApril1,2011.PublishedApril2011.Originallyapprovedin2005.Lastpreviouseditionapprovedin2005asF2475 – 05.DOI:10.1520/F2475-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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F2475 – 11
sue or there may be a question as to whether the packaging may negatively impact the contained device. Guidelin
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