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ASTM F881-94(2006)

(Specification)

Standard Specification for Silicone Elastomer Facial Implants

Standard Specification for Silicone Elastomer Facial Implants

ABSTRACT
This specification covers the requirements for silicone elastomer implants used in facial surgery, that is, chin, nasal, malar, and ear implants. The primary material of construction shall be fully vulcanized silicone elastomer. Implants may have orientation means or sites of attached fixation materials, or both. Different tests shall be conducted in order to determine the following properties of elastomers: elongation at failure, tensile strength, modulus, and tear.
SCOPE
1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).
1.2 Limitations This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom-fabricated prosthesis manufactured to any other specification.
The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7, of this specification: 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.

General Information

Status
Historical
Publication Date
31-Aug-2006
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.32 - Plastic and Reconstructive Surgery
Current Stage
Ref Project

Relations

Replaces
ASTM F881-94(2000) - Standard Specification for Silicone Elastomer Facial Implants
Effective Date
01-Sep-2006

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ASTM F881-94(2006) - Standard Specification for Silicone Elastomer Facial ImplantsASTM F881-94(2006) - Standard Specification for Silicone Elastomer Facial Implants
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ASTM F881-94(2006) - Standard Specification for Silicone Elastomer Facial Implants
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:F881 −94(Reapproved 2006)
Standard Specification for
Silicone Elastomer Facial Implants
ThisstandardisissuedunderthefixeddesignationF881;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
Medical and Surgical Devices (Withdrawn 2012)
1.1 This specification covers the requirements for silicone
2.2 Other Documents:
elastomer implants used in facial surgery (that is, chin, nasal,
United States Pharmacopeia, Volume XX
malar, and ear implants).
Federal Register, Title 21, Part 820
1.2 Limitations—This specification does not cover implants
Dow Corning Corporate Test Method—CTM 0930—
containing silicone gels or other gels or liquids. It does not
Adhesion—OneHundred Eighty Degree Shear—Thin
necessarily cover any custom-fabricated prosthesis manufac- 6
Elastometric Substrates
tured to any other specification.
3. Terminology
1.3 The following safety hazards caveat pertains only to the
mechanical testing and test methods portion, Section 7, of this
3.1 Definitions:
specification: This standard does not purport to address all of
3.1.1 fixation site—an area on the surface of the implant
the safety concerns, if any, associated with its use. It is the
which has material on it that allows tissue ingrowth.
responsibility of the user of this standard to establish appro-
3.1.2 fused or adhered joints—all junctures of dissimilar
priate safety and health practices and determine the applica-
materials; and all junctures of fully or partly formed or
bility of regulatory limitations prior to use.
preformed materials bonded or fused together to form a single
implant unit.
2. Referenced Documents
3.1.3 Discussion—Implants made from one material by a
2.1 ASTM Standards:
single charge of unvulcanized elastomer by one-step
D412 Test Methods forVulcanized Rubber andThermoplas-
compression, transfer, or reactive injection molding are not
tic Elastomers—Tension
considered to have fused or adhered joints.
D624 Test Method for Tear Strength of Conventional Vul-
3.1.4 orientation means—any locus on the surface of the
canized Rubber and Thermoplastic Elastomers
implant that is modified to assist the surgeon to position the
D2240 Test Method for Rubber Property—Durometer Hard-
implant.
ness
F604 Specification for Silicone Elastomers Used in Medical
4. Significance and Use
Applications (Withdrawn 2001)
4.1 The prostheses described in this specification are in-
F748 PracticeforSelectingGenericBiologicalTestMethods
tended for implant use in the facial area.
for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomate-
5. Materials
rials for Surgical Implants with Respect to Effect of
5.1 The primary material of construction shall be fully
Materials on Muscle and Bone
vulcanized silicone elastomer.
5.1.1 Implants may have orientation means or sites of
attached fixation materials, or both.
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of 5.2 Biocompatibility:
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
5.2.1 Biologicaltestingtoensurethesafetyoffacialimplant
Current edition approved Sept. 1, 2006. Published September 2006. Originally
devices shall be selected and conducted in accordance with
approved in 1984. Last previous edition approved in 2000 as F881 – 94 (2000).
Practices F748 and F981.
DOI: 10.1520/F0881-94R06.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on Available from Mack Publishing Co., 1991 N Hampton St. Easton, PA. 18042.
the ASTM website. AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
The last approved version of this historical standard is referenced on Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
www.astm.org. Available from Dow Corning Corp., P.O. Box 994, Midland, MI 48686-0994.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F881−94 (2006)
5.2.2 In addition to biological testing as recommended by similar techniques are tested in accordance with Dow Corning
Practices F748 and F981, other biological testing may be Corporate Test Method-CTM 0930.
appropriate.
8. Sterilization
8.1 The units may be supplied presterilized in accordance
6. Dimensions
with the United States Pharmacopeia and good manufacturing
6.1 The individual shape, range of sizes, and measurements
practices released by the Food and Drug Administration
are determined by the manufacturer.
(FDA).
6.1.1 Define sizing codes by typical dimensions and
8.2 Instructions for cleaning and sterilization shall be sup-
volumes, where applicable.
plied with the package insert.
7. Mechanical Testing and Test Methods
9. Packaging, Labeling, and Package Inserts
7.1 Typical Physical Properties of Elastomers:
9.1 Packaging (Primary):
7.1.1 Elongation at Failure—The elongation at failure shall 9.1.1 Packages shall be sealed to prevent contamination and
be 200 %, minimum, when tested in accordance with Test to maintain sterility.
Methods D412. 9.1.2 Units shall be packaged with suitable containers that
7.1.2 Durometer—The
...

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