ASTM F2051-00(2022)

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: F2051 −00 (Reapproved 2022)
Standard Specification for
Implantable Saline-Filled Breast Prostheses
This standard is issued under the fixed designation F2051; 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 F703Specification for Implantable Breast Prostheses
F748PracticeforSelectingGenericBiologicalTestMethods
1.1 This specification covers the requirements for single-
for Materials and Devices
use, saline inflatable, smooth and textured silicone shell
F1251Terminology Relating to Polymeric Biomaterials in
implantable breast prostheses intended for use in surgical
Medical and Surgical Devices (Withdrawn 2012)
reconstruction, augmentation, or replacement of the breast.
2.2 Other Documents:
1.2 Limitations:
USP(United States Pharmacopeia)
1.2.1 This specification does not cover custom fabricated
Federal RegisterTitle 21, Part 820
implantable breast prostheses.
Association for the Advancement of Medical Instrumenta-
1.2.2 This specification does not cover gel/saline type
tion
implants, which are within the scope of Specification F703.
ANSI/AAMI/ISO 10993-1Biological Testing of Medical
1.3 This standard does not purport to address all of the
and Dental Materials and Devices—Part 1: Guidance on
safety concerns, if any, associated with its use. It is the
Selection of Tests
responsibility of the user of this standard to establish appro-
ANSI/AAMI/ST50-1995Dry Heat (Heated Air) Sterilizers
priate safety, health, and environmental practices and deter-
ANSI/AAMI/ISO11135-1994MedicalDevices—Validation
mine the applicability of regulatory limitations prior to use.
and Routine Control of Ethylene Oxide Sterilization
1.4 This international standard was developed in accor-
ANSI/AAMI/ISO 11137-1994Sterilization of Health Care
dance with internationally recognized principles on standard-
Products—Requirements for Validation and Routine and
ization established in the Decision on Principles for the
Routine Control—Radiation Sterilization
Development of International Standards, Guides and Recom-
ANSI/AAMI/ISO 11134-1993Sterilization of Health Care
mendations issued by the World Trade Organization Technical
Products—Requirements for Validation and Routine
Barriers to Trade (TBT) Committee.
Control—Industrial Moist Heat Sterilization
Parenteral Drug Association1981 Technical Report No. 3,
2. Referenced Documents
Validation of Dry Heat Processes Used for Sterilization
2.1 ASTM Standards:
and Depyrogenation
D412TestMethodsforVulcanizedRubberandThermoplas-
FDADraft Guidance for Preparation of PMA Applications
tic Elastomers—Tension
for Silicone Inflatable (Saline) Breast Prostheses
D1349Practice for Rubber—Standard Conditions for Test-
ing 3. Terminology
D3389Test Method for Coated FabricsAbrasion Resistance
3.1 Definitions:
(Rotary Platform Abrader)
F604Specification for Silicone Elastomers Used in Medical
Applications (Withdrawn 2001)
United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA
1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,
Rockville, NC 00852.
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This specification is under the jurisdiction of ASTM Committee F04 on Federal Register,Vol 43, No. 141, Friday, July 21, 1978 Part II.Available from
Medical and Surgical Materials and Devices and is the direct responsibility of U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St.,
Subcommittee F04.32 on Plastic and Reconstructive Surgery. NW, Mail Stop: SDE, Washington, DC 20401, http://www.access.gpo.gov.
Current edition approved Oct. 1, 2022. Published October 2022. Originally Available from Association for the Advancement of Medical Instrumentation
approved in 2000. Last previous edition approved in 2014 as F2051–00 (2014). (AAMI), 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795. http://
DOI: 10.1520/F2051-00R22. www.aami.org.
2 7
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
Standards volume information, refer to the standard’s Document Summary page on Available from Parenteral Drug Association (PDA), Bethesda Towers, 4350
the ASTM website. East West Hwy., Suite 200, Bethesda, MD 20814. http://www.pda.org.
3 9
The last approved version of this historical standard is referenced on Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
www.astm.org. Rockville, MD 20857, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2051 − 00 (2022)
3.1.1 fused or adhered joints (seams)—sites in the shell or intended applications. When new information becomes avail-
other parts of implantable breast prosthesis where materials able or changes in state-of-the-art science and technology
have been joined (fused or bonded) together, with or without occur and relevance to subject prostheses has been established
adhesive, as part of the manufacturing process. by valid science, it is intended that this specification will be
revised in accordance with ASTM guidelines.
3.1.2 inflatable breast prosthesis—implantable breast pros-
thesisnotcontainingsiliconegel;implantablebreastprosthesis
5. Materials
designed and provided prefilled with saline or empty and to be
5.1 Silicone Elastomer—Select and specify elastomers for
filled with saline at the time of use to adjust the volume of the
use in implantable breast prostheses in keeping with Specifi-
prosthesis.
cation F604.
3.1.2.1 type 1, fixed volume inflatable breast prosthesis—an
5.1.1 Shell—The following describes suitable silicone elas-
implantable breast prosthesis composed of a single lumen,
tomer compositions for use as the primary material of con-
emptywhensuppliedandhavingavalvetofacilitatefillingthe
struction of the shell including the exterior (tissue contact)
lumen with saline at the time of use.
surface:
3.1.2.2 type 2, variable volume inflatable breast
polymer types MQ or VMQ
prosthesis—an implantable breast prosthesis composed of a
fillers A, B, or C
additive J (for radiopacity)
single lumen, empty when supplied and having a valve to
catalysts B, G, J, or K
facilitate filling the lumen with a portion of the volume of
NOTE 1—The compositions listed in this section are not intended to
saline at the time of use. The valve system is designed to
limit the compositions that may be used providing all other requirements
facilitate further post-operative adjustment with saline as
of this specification are satisfied.
instructed in product literature.
5.1.2 Fabrication—Fabrication techniques must necessarily
3.1.2.3 type 3, fixed volume inflatable breast prosthesis—an
be dependent on the type of elastomer, the portion of an
implantable breast prosthesis composed of a single lumen,
implantable breast prosthesis fabricated, its shape, location,
prefilled with saline by the manufacturer prior to time of use.
and function on the prosthesis.
3.1.3 lumen—a cavity within a shell of an implantable
5.1.3 Vulcanization and Postcure—Timeandtemperatureof
breast prosthesis. Inflatable lumens are accessible by valve to
vulcanizationandpostcuremustbeadjustedwithconsideration
facilitate the addition of saline to adjust the volume of the
of the elastomer type and the multi-step fabrication require-
prosthesis at the time of use.
ments of specific prostheses. Final postcure is typically done
3.1.4 orientation means—any mark or palpable portion of only after the shell or shells and all other portions have been
completely assembled. Time and temperature of final postcure
an implantable breast prosthesis to assist the surgeon in
positioning the implant. shall be adequate to drive the chemistry of vulcanization of all
elastomertocompletionandremoveby-productsofthecurein
3.1.5 saline—only sodium chloride for injection (USP) is
keeping with the chemical stoichiometry of the specific cure
recommended for filling lumens of inflatable breast prosthesis.
system (e.g., after postcure no additional vulcanization should
3.1.6 shell—a silicone elastomer continuous layer or mem-
occurwhenheatedadditionallyatrecommendedcuretempera-
branecontainer(sac)whichenclosesalumenofanimplantable
ture).
breast prosthesis.
5.1.4 Physical Property Testing and Requirements—
3.1.7 silicone elastomer—an elastomer containing cross-
Silicone elastomer shells shall demonstrate an acceptable
linked silicone polymer and fumed amorphous (non-
response in physical property tests. Prostheses for testing
crystalline) silica as a reinforcing filler.
should be selected from standard production batches which
3.1.8 valve—sealableorself-sealingopeninginaninflatable have gone through all manufacturing processes, including
sterilization.
prosthesis,extendingfromtheexteriorsurfaceoftheshellinto
a lumen, designed to facilitate addition of saline at the time of 5.1.4.1 Specimen Preparation—Cut required tests speci-
mens from shells with Test Method D412 dies. Devices or
use or postoperatively to adjust prosthesis volume.
specimensshallbeconditionedbeforetestingforatleast1hat
3.1.9 patch—apieceofsiliconeelastomerwhichcoversand
23 6 2°C (73.4 6 3.6°F).
seals the hole which results from the manufacturing process of
5.1.4.2 Dimension—The individual shape, range of volume
shell fabrication.
(displacement), base size, and anterior projection are deter-
4. Significance and Use
mined by the manufacturer.
4.1 This specification contains requirements based on state-
6. Volume and Dimensions
of-the-art science and technology as applicable to various
6.1 Volumes of Prostheses:
considerations that have been identified as important to ensure
6.1.1 Saline Inflatable Prostheses—The designed or mini-
reasonable safety and efficacy as it relates to the biocompat-
mum and maximum recommended volume of saline fill shall
ibility and the mechanical integrity of the device components
be listed in instructions for use.
in implantable breast prostheses.
4.1.1 This specification is not intended to limit the science 6.2 Dimensions—Therangesofshapes,volumes,basesizes,
and technology that may be considered and applied to ensure and anterior projections are determined by the manufacturer.
performance characteristics of subject breast prostheses in Pertinent information shall be contained in the package insert.
F2051 − 00 (2022)
7. Fixation Sites 9.2.3.3 Tensile Set—The tensile set shall be <10%, deter-
mine in accordance withTest MethodD412. Determine tensile
7.1 Thepresenceoffixationsitesonanytypeofimplantable
at 300 % elongation, stress the specimen for 3 min, then allow
breastprosthesisisoptional.Whenused,thesizeandlocations
3 min for relaxation.
of fixation sites shall be clearly stated in instructions for use.
9.2.3.4 Fused or Adhered Joined—Requirements for ad-
heredorfusedsiliconerubbermaterialsshallbecriticaltotheir
8. Orientation Means
integrity.
8.1 Orientation means are optional features of subject pros-
(1) Critical Fused or Adhered Joints—Joints or seams that
theses. When orientation means are claimed, the location and
are critical to the integrity of the prosthesis envelope shall not
recommended techniques for use shall be clearly described in
fail when the shell adjacent to the joint is stressed to 200%
instructions for use.
elongation for 10s (see Fig. 1).
(2) Noncritical Fused or Adhered Joints—Fused joints or
9. Test Methods and Requirements
seams that are bonded to the prosthesis envelope but are not
critical to the envelope integrity (fixation sites, orientation
9.1 Biocompatibility:
means, valve covers, and so forth) shall not fail when the shell
9.1.1 Practice F748—New or existing materials shall be in
adjacent to the joint is stressed to 100 % elongation for 10s
compliance with Practice F748 or other accepted standards
(see Fig. 1).
such as ISO/AAMI/ANSI 10993-1. Assays recommended by
9.3 Shell Rupture/Failure Testing—No standard test for
Practice F748 include cell culture cytotoxicity assays; short-
assessingshellrupturehasyetbeendeveloped.Whensuchtest
term intramuscular implantation assay; short-term subcutane-
method has been developed it will be added to this specifica-
ous assay; carcinogenicity; long-term implant test; systemic
tion.
injection (acute toxicity) assay; sensitization assay; mutagen-
icity; and pyrogenicity.
9.4 Valve Competence:
9.1.2 Silicone Saline-Filled Prostheses—Test specimens for
9.4.1 Test Method—Prior to testing, manipulate valve to
chronic implantation assays (carcinogenicity and long-term
duplicate its use for filling and inflate prosthesis with saline as
implanttests)shallbefabricatedfromthesamecombinationof
described in instructions for use. Test such manipulated valve
silicone elastomer and by the same or similar procedures and
at both high and low retrograde pressures. Use air or other
conditions used in fabricating prostheses. The thickness of
suitable gas, distilled water, or isotonic saline as test media.
shell in specimens shall be typical of thickness used in
Pressures in order to be tested are 30 cm and 3 cm H O
prostheses.
pressure, respectively. Maintain each test pressure for 5 min.
9.1.3 Prior Biocompatibility Assays—When prior biocom-
When air or other suitable gases are tested, immediately
patibility data are available for silicone elastomer in
...