ASTM F703-18

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F703 −18
Standard Specification for
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Implantable Breast Prostheses
ThisstandardisissuedunderthefixeddesignationF703;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F1251 Terminology Relating to Polymeric Biomaterials in
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Medical and Surgical Devices (Withdrawn 2012)
1.1 This specification covers the requirements for silicone
F2038 GuideforSiliconeElastomers,Gels,andFoamsUsed
gel-filled and saline-inflatable silicone gel-filled implantable
in Medical Applications Part I—Formulations and Un-
breast prostheses intended for use in surgical reconstruction,
cured Materials
augmentation, or replacement of the breast.
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
1.2 Limitations—This specification does not cover custom
in Medical Applications Part II—Crosslinking and Fabri-
fabricated implantable breast prostheses.
cation
1.3 Single-use saline-inflatable, smooth, and textured sili- F2051 Specification for Implantable Saline Filled Breast
Prosthesis
cone shell implantable breast prostheses are addressed in
Specification F2051.
2.2 Other Documents:
Saline, Silicone Gel, and Alternative Breast Implants—
1.4 The values stated in SI units are to be regarded as the
Guidance for Industry and FDA Staff, November 17,
standard. The inch-pound units given in parentheses are for
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2006
information only.
ISO/AAMI/ANSI10993-1 BiologicalEvaluationofMedical
1.5 This standard does not purport to address all of the
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Devices—Part 1: Evaluation and Testing
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety, health, and environmental practices and deter-
3.1 Definitions:
mine the applicability of regulatory limitations prior to use.
3.1.1 barrier coat, n—a silicone elastomer layer that is part
1.6 This international standard was developed in accor-
of the shell of a silicone gel implantable breast prosthesis that
dance with internationally recognized principles on standard-
retards silicone bleed.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
3.1.2 fixation site, n—an area of the shell of an implantable
mendations issued by the World Trade Organization Technical
breast prosthesis containing material that allows tissue in-
Barriers to Trade (TBT) Committee.
growth.
3.1.3 fused or adhered joints (seams), n— sites in the shell
2. Referenced Documents
or other parts of an implantable breast prosthesis where
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2.1 ASTM Standards:
materials have been joined (fused or bonded) together, with or
D412 Test Methods forVulcanized Rubber andThermoplas-
without an adhesive, as part of the manufacturing process.
tic Elastomers—Tension
3.1.4 gel bleed, n—diffusion of liquid silicone components
D1349 Practice for Rubber—Standard Conditions for Test-
of silicone gel through the shell of an implantable breast
ing
prosthesis.
F748 PracticeforSelectingGenericBiologicalTestMethods
3.1.5 gel-filled breast prosthesis, n—implantable breast
for Materials and Devices
prosthesis designed and provided with a pre-filled, fixed
volume of silicone gel.
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This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
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Current edition approved Feb. 1, 2018. Published March 2018. Originally The last approved version of this historical standard is referenced on
approved in 1981. Last previous edition approved in 2007 as F703 – 07 which was www.astm.org.
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withdrawn January 2016 and reinstated February 2018. DOI: 10.1520/F0703-18. Available from U.S. Department of Health and Human Services, Food and
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.fda.gov/cdrh/ode/guidance/1239.
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Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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
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F703−18
3.1.5.1 Type I breast prosthesis, n—implantable breast pros- or removing saline to or from the prosthesis to increase or
thesis containing a single lumen containing a fixed amount of decrease prosthe
...