ASTM F2051-00(2006)
(Specification)Standard Specification for Implantable Saline Filled Breast Prosthesis
Standard Specification for Implantable Saline Filled Breast Prosthesis
ABSTRACT
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast. This specification does not cover custom fabricated implantable breast prostheses and other gel-saline type implants. The silicone elastomer compositions for use as primary material of construction of the shell including the exterior (tissue contact) surface shall include: (1) polymer types MQ or VMQ, (2) fillers A, B, or C, (3) additive J (for radiopacity), and (4) catalysts B, G, J, or K. The requirements for the following are specified: (1) fabrication including vulcanization and postcure, (2) volume and dimension of saline filled prostheses, (3) fixation sites, and (4) orientation means. The following tests shall be performed: (1) physical property tests such as shell leakage and tension tests (2) biocompatibility test, (3) shell rupture or failure test, (4) valve competence, and (5) abrasion test. The physical property requirements are specified for (1) shell percent elongation, breaking strength, and tensile set, and (2) critical and non-critical fused or adhered joints. Illustrations for testing fused or adhered joints are provided. Requirements for sterilization, packaging, labeling, and package inserts are detailed as well.
SCOPE
1.1 This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 Limitations
1.2.1 This specification does not cover custom fabricated implantable breast prostheses.
1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F 703.
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.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2051 −00(Reapproved 2006)
Standard Specification for
Implantable Saline Filled Breast Prosthesis
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 2.2 Other Documents:
USP (United States Pharmacopeia)
1.1 Thisspecificationcoverstherequirementsforsingleuse
Federal Register, Title 21, Part 820
saline inflatable, smooth and textured silicone shell implant-
Association for the Advancement of Medical Instrumenta-
able breast prostheses, intended for use in surgical
tion
reconstruction, augmentation, or replacement of the breast.
ANSI/AAMI/ISO 10993-1Biological Testing of Medical
1.2 Limitations:
and Dental Materials and Devices—Part 1: Guidance on
1.2.1 This specification does not cover custom fabricated
Selection of Tests
implantable breast prostheses. 7
ANSI/AAMI/ST50-1995Dry Heat (Heated Air) Sterilizers
1.2.2 This specification does not cover gel/saline type
ANSI/AAMI/ISO 111355-1994 Medical Devices—
implants, which are within the scope of Specification F703.
Validation and Routine Control of Ethylene Oxide Steril-
1.3 This standard does not purport to address all of the ization
safety concerns, if any, associated with its use. It is the
ANSI/AAMI/ISO 11137-1994Sterilization of Health Care
responsibility of the user of this standard to establish appro- Products—Requirements for Validation and Routine and
priate safety and health practices and determine the applica-
Routine Control—Radiation Sterilization
bility of regulatory limitations prior to use. ANSI/AAMI/ISO 11134-1993Sterilization of Health Care
Products—Requirements for Validation and Routine
2. Referenced Documents Control—Industrial Moist Heat Sterilization
Parenteral Drug Association,1981 Technical Report No. 3,
2.1 ASTM Standards:
Validation of Dry Heat Processes Used for Sterilization
D412TestMethodsforVulcanizedRubberandThermoplas-
and Depyrogenation
tic Elastomers—Tension
FDADraft Guidance for Preparation of PMA Applications
D1349Practice for Rubber—Standard Temperatures for
for Silicone Inflatable (Saline) Breast Prostheses
Testing
D3389Test Method for Coated FabricsAbrasion Resistance
3. Terminology
(Rotary Platform Abrader)
3.1 Definitions:
F604Specification for Silicone Elastomers Used in Medical
Applications (Withdrawn 2001) 3.1.1 fused or adhered joints (seams)—sites in the shell or
other parts of implantable breast prosthesis where materials
F703Specification for Implantable Breast Prostheses
F748PracticeforSelectingGenericBiologicalTestMethods have been joined (fused or bonded) together, with or without
adhesive, as part of the manufacturing process.
for Materials and Devices
F1251Terminology Relating to Polymeric Biomaterials in
Medical and Surgical Devices (Withdrawn 2012)
United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA
1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,
Rockville, NC 00852.
1 5
This specification is under the jurisdiction of ASTM Committee F04 on FederalRegister,Vol.43,No.141,Friday,July21,1978PartII.Availablefrom
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 Sept. 1, 2006. Published September 2006. Originally Available from Association for the Advancement of Medical Instrumentation
approved in 2000. Last previous edition approved in 2000 as F2051–00. DOI: (AAMI), 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201–4795. http://
10.1520/F2051-00R06. 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 (2006)
3.1.2 inflatable breast prosthesis—implantable breast pros- valid science, it is intended that this specification will be
theses not containing silicone gel— implantable breast pros- revised in accordance with ASTM guidelines.
thesesdesignedandprovidedprefilledwithsalineoremptyand
to be filled with saline at the time of use to adjust the volume 5. Materials
of the prosthesis.
5.1 Silicone Elastomer—Select and specify elastomers for
3.1.2.1 type 1—fixed volume inflatable breast
use in implantable breast prostheses in keeping with Specifi-
prosthesis—an implantable breast prosthesis composed of a
cation F604.
single lumen, empty when supplied and having a valve to
5.1.1 Shell—The following describes suitable silicone elas-
facilitate filling the lumen with saline at the time of use.
tomer compositions for use as the primary material of con-
3.1.2.2 type 2—variable volume inflatable breast
struction of the shell including the exterior (tissue contact)
prosthesis—an implantable breast prosthesis composed of a
surface:
single lumen, empty when supplied and having a valve to
polymer types MQ or VMQ
facilitate filling the lumen with a portion of the volume of
fillers A, B or C
saline at the time of use. The valve system is designed to additive J (for radiopacity)
catalysts B, G, J or K
facilitate further post-operative adjustment with saline as
instructed in product literature.
NOTE1—Thecompositionlistedinthissectionarenotintendedtolimit
thecompositionsthatmaybeusedprovidingallotherrequirementsofthis
3.1.2.3 type 3—fixed volume inflatable breast
specification are satisfied.
prosthesis—an implantable breast prosthesis composed of a
singlelumen,prefilledwithsalinebythemanufacturerpriorto 5.1.2 Fabrication—Fabrication techniques must necessarily
time of use.
be dependent on the type of elastomer, the portion of an
implantablebreastprosthesisfabricated,itsshape,locationand
3.1.3 lumen—a cavity within a shell of an implantable
function on the prosthesis.
breast prosthesis. Inflatable lumens are accessible by valve to
5.1.3 Vulcanization and Postcure—Timeandtemperatureof
facilitate the addition of saline to adjust the volume of the
prosthesis at the time of use. vulcanizationandpostcuremustbeadjustedwithconsideration
of the elastomer type and the multi-step fabrication require-
3.1.4 orientation means—any mark or palpable portion of
ments of specific prostheses. Final postcure is typically done
an implantable breast prosthesis to assist the surgeon in
only after the shell or shells and all other portions have been
positioning the implant.
completely assembled. Time and temperature of final postcure
3.1.5 saline—only sodium chloride for injection (USP) is
shall be adequate to drive the chemistry of vulcanization of all
recommended for filling lumens of inflatable breast prosthesis.
elastomertocompletionandremoveby-productsofthecurein
3.1.6 shell—a silicone elastomer continuous layer or mem-
keeping with the chemical stoichiometry of the specific cure
branecontainer(sac)whichenclosesalumenofanimplantable
system (e.g., after postcure no additional vulcanization should
breast prosthesis.
occurwhenheatedadditionallyatrecommendedcuretempera-
3.1.7 silicone elastomer—an elastomer containing cross- ture).
linked silicone polymer and fumed amorphous (non-
5.1.4 Physical Property Testing and Requirements—
crystalline) silica as a reinforcing filler.
Silicone elastomer shells shall demonstrate an acceptable
response in physical property tests. Prostheses for testing
3.1.8 valve—sealableorselfsealingopeninginaninflatable
should be selected from standard production batches which
prosthesis,extendingfromtheexteriorsurfaceoftheshellinto
have gone through all manufacturing processes, including
a lumen, designed to facilitate addition of saline at the time of
sterilization.
use or postoperatively to adjust prosthesis volume.
5.1.4.1 Specimen Preparation—Cut required tests speci-
3.1.9 patch—apieceofsiliconeelastomerwhichcoversand
mens from shells with Test Method D412 Dies. Devices or
seals the hole which results from the manufacturing process of
specimensshallbeconditionedbeforetestingforatleast1hat
shell fabrication.
23 6 2°C (73.4 6 3.6°F).
4. Significance and Use
5.1.4.2 Dimension—The individual shape, range of volume
(displacement), base size, and anterior projection are deter-
4.1 This specification contains requirements based on state-
mined by the manufacturer.
of-art science and technology as applicable to various consid-
erations that have been identified as important to ensure
6. Volume and Dimensions
reasonable safety and efficacy as it relates to the biocompat-
ibility and the mechanical integrity of the device components
6.1 Volumes of Prostheses:
in implantable breast prostheses.
6.1.1 Saline Inflatable Prostheses—The designed or mini-
4.1.1 This specification is not intended to limit the science
mum and maximum recommended volume of saline fill shall
and technology that may be considered and applied to assure
be listed in instructions for use.
performance characteristics of subject breast prostheses in
intended applications. When new information becomes avail- 6.2 Dimensions—Therangesofshapes,volumes,basesizes,
able or changes in state-of-art science and technology occur and anterior projections are determined by the manufacturer.
and relevance to subject prostheses has been established by Pertinent information shall be contained in the package insert.
F2051−00 (2006)
7. Fixation Sites of the specific biocompatibility requirements of Practice F748
or equivalent methodology.
7.1 Thepresenceoffixationsitesonanytypeofimplantable
breastprosthesisisoptional.Whenused,thesizeandlocations
9.2 Physical Properties:
of fixation sites shall be clearly stated in instructions for use.
9.2.1 Unless otherwise specified, the standard temperature
for testing shall be 23 6 2°C (73.4 6 3.6°F). When testing at
8. Orientation Means
any other temperature is required, use one of temperatures
8.1 Orientation means are optional features of subject pros-
specified in Practice D1349. Tests are as follows:
theses. When orientation means are claimed, the location and
9.2.2 Shell Leakage Testing—Filla5to8qt stainless steel
recommended techniques for use shall be clearly described in
bowl with 70 % isopropyl alcohol. Submerge patched shell in
instructions for use.
bowl and gently apply pressure to the shell assembly. Visually
inspect for any bubbles. Reposition shell in hand until entire
9. Test Methods and Requirements
surface of shell has been tested while exposed. Reject shells
9.1 Biocompatibility:
whenever any bubbles are seen.
9.1.1 Practice F748—New or existing materials shall be in
9.2.3 Shell—Cut the test specimens from units made by
compliance with Practice F748 or other accepted standards
standard production processes including sterilization. Clean
such as ISO/AAMI/ANSI 10993-1. Assays recommended by
with appropriate (polar, for example, 2-propanol, or non polar,
PracticeF748includeCellCultureCytotoxicityAssays,Short-
for example, 1,1,1-trichloroethane) solvent if necessary.
Term Intramuscular Implantation Assay, Short-Term Subcuta-
9.2.3.1 Percent Elongation—Three thickness measurements
neous Assay, Carcinogenicity, Long-Term Implant Test, Sys-
shall be taken prior to test, percentage elongation shall be 350
temic Injection (Acute Toxicity) Assay, Sensitization Assay,
% minimum when tested in accordance with Test Method
Mutagenicity, and Pyrogenicity.
D412, Die C.
9.1.2 Silicone Saline Filled Prostheses—Test specimens for
9.2.3.2 Breaking Strength—UltimateBreakingForceinTen-
chronic implantation assays (carcnogenciity and long term
sion shall be no less when 2.5 lb (11.12 N) when tested in
implanttests)shallbefabricatedfromthesamecombinationof
accordance with Test Method D412, Die C.
silicone elastomer and by the same or similar procedures and
9.2.3.3 Tensile Set—The tensile set shall be <10%, deter-
conditions used in fabricating prostheses. The thickness of
mine in accordance withTest MethodD412. Determine tensile
shell in specimens shall be typical of thickness used in
at 300 % elongation, stress the specimen for 3 min, then allow
prostheses.
3 min for relaxation.
9.1.3 Prior Biocompatibility Assays—When prior biocom-
patibility data are available for silicone elastomer in clinical 9.2.3.4 Fused or Adhered Joined—Requirements for ad-
use in breast implants, even if not done by the exact protocols heredorfusedsiliconerubbermaterialsshallbecriticaltotheir
described in more standards, such data may satisfy all or part integrity.
FIG. 1Testing Fused or Adhered Joints
F2051−00 (2006)
(1) Critical Fused or Adhered Joints—Joints or seams that 10.2 If user sterilization or re-sterilization of prostheses are
are critical to the integrity of the prostheses envelope shall not intended, validated instructions for cleaning and sterilization
fail when the shell adjacent to the joint stressed to 200 % shall be supplied with package insert.
elongation for 10s (see Fig. 1).
11. Packaging, Labelling, and Package Inserts
(2) Non-Critical Fused or Adhered Joints—Fused joints or
seams that are bonded to the prosthesis envelope but are not 11.1 Packaging—Prostheses shall be packaged to protect
critical to the envelope integrity (fixation sites, orientation
against damage and maintain cleanliness and sterility during
means, valve covers, and so forth) shall not fail when the shell the customary conditions of processing, storage, handling and
adjacent to the joint is stressed to 100 % elongation for 10s
distribution.
(see Fig. 1).
11.2 Labeling—Each package shall be labelled in a manner
9.3 Shell Rupture/Failure Testing—No standard test for
that ensures the labelling arrives at the point of use with the
assessingshellrupturehasyetbeendeveloped.Whensuchtest prostheses. The package labelling shall include the following
method has bee
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