ASTM F2051-00(2014)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2051 −00 (Reapproved 2014)
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 Conditions for Test-
for Silicone Inflatable (Saline) Breast Prostheses
ing
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 Oct. 1, 2014. Published November 2014. Originally Available from Association for the Advancement of Medical Instrumentation
approved in 2000. Last previous edition approved in 2006 as F2051–00 (2006). (AAMI), 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201–4795. http://
DOI: 10.1520/F2051-00R14. 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 (2014)
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 (2014)
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 prostheses envelope shall not
recommended techniques for use shall be clearly described in
fail when the shell adjacent to the joint stressed to 200 %
instructions for use.
elongation for 10s (see Fig. 1).
(2) Non-Critical 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
PracticeF748includeCellCultureCytotoxicityAssays,Short-
assessingshellrupturehasyetbeendeveloped.Whensuchtest
Term Intramuscular Implantation Assay, Short-Term Subcuta-
method has been developed it will be added to this specifica-
neous Assay, Carcinogenicity, Long-Term Implant Test, Sys-
tion.
temic Injection (Acute Toxicity) Assay, Sensitization Assay,
Mutagenicity, 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 (carcnogenciity 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 clinical
immersevalveopeninginwatertocheckforleakage(bubbles).
use in breast implants, even if not done by the exact protocols
With water or isotonic saline check for droplets at the valve
described in more standards, such data may satisfy all or part
opening.
of the specific biocompatibility requirements of Practice F748
9.4.2 Test Requirements—No observable or detectable leak-
or equivalent methodology.
age.
9.2 Physical Properties:
9.5 Abrasion Testing—The criteria for shell abrasion in this
9.2.1 Unless otherwise specified, the standard temperature testing have not been established.
for testing shall be 23 6 2°C (73.4 6 3.6°F). When testing at 9.5.1 Abrasion Testing—Wet method—See A1.1.
any other temperature is required, use one of temperatures
9.5.2 Abrasion Testing—Dry method—See A1.2.
specified in Practice D1349. Tests are as follows:
9.5.3 Particlesizesgeneratedbythesetestmethodsmaynot
9.2.2 Shell Leakage Testing—Filla5to8qt stainless steel
beabletobecorrelatedwithparticulatesresultingfromclinical
bowl with 70 % isopropyl alcohol. Submerge patched shell in use, and therefore, has questionable meaning.
bowl and gently apply pressure to the shell assembly. Visually
inspect for any bubbles. Reposition shell in hand until entire
10. Sterilization
surface of shell has been tested while exposed. Reject shells
10.1 Implantable breast prostheses may be supplied pre-
whenever any bubbles are seen.
sterilizedinaccordancewithcurrentAMIandPDAprocedures
9.2.3 Shell—Cut the test specimens from units made by
and
...