ASTM F881-94(2022)
(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.
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 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.
General Information
Relations
Standards Content (Sample)
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: F881 −94 (Reapproved 2022)
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 F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.1 This specification covers the requirements for silicone
F981 Practice for Assessment of Compatibility of Biomate-
elastomer implants used in facial surgery (that is, chin, nasal,
rials for Surgical Implants with Respect to Effect of
malar, and ear implants).
Materials on Muscle and Insertion into Bone
1.2 Limitations—This specification does not cover implants
F1251 Terminology Relating to Polymeric Biomaterials in
containing silicone gels or other gels or liquids. It does not 3
Medical and Surgical Devices (Withdrawn 2012)
necessarily cover any custom fabricated prosthesis manufac-
2.2 Other Documents:
tured to any other specification.
United States Pharmacopeia Volume XX
1.3 The following safety hazards caveat pertains only to the
Federal Register Title 21, Part 820
mechanical testing and test methods portion, Section 7, of this
Dow Corning Corporate Test Method CTM 0930 Adhe-
specification: This standard does not purport to address all of
sion—One Hundred Eighty Degree Shear—Thin Elasto-
the safety concerns, if any, associated with its use. It is the 6
metric Substrates
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
3. Terminology
mine the applicability of regulatory limitations prior to use.
3.1 Definitions:
1.4 This international standard was developed in accor-
3.1.1 fixation site—an area on the surface of the implant
dance with internationally recognized principles on standard-
which has material on it that allows tissue ingrowth.
ization established in the Decision on Principles for the
3.1.2 fused or adhered joints—all junctures of dissimilar
Development of International Standards, Guides and Recom-
materials, and all junctures of fully or partly formed or
mendations issued by the World Trade Organization Technical
preformed materials bonded or fused together to form a single
Barriers to Trade (TBT) Committee.
implant unit.
2. Referenced Documents
3.1.2.1 Discussion—Implants made from one material by a
single charge of unvulcanized elastomer by one-step
2.1 ASTM Standards:
compression, transfer, or reactive injection molding are not
D412 Test Methods forVulcanized Rubber andThermoplas-
considered to have fused or adhered joints.
tic Elastomers—Tension
D624 Test Method for Tear Strength of Conventional Vul- 3.1.3 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-
tended for implant use in the facial area.
This specification is under the jurisdiction of ASTM Committee F04 on
5. Materials
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
5.1 The primary material of construction shall be fully
Current edition approved Oct. 1, 2022. Published October 2022. Originally
vulcanized silicone elastomer.
approved in 1984. Last previous edition approved in 2014 as F881 – 94 (2014).
DOI: 10.1520/F0881-94R22.
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 (2022)
5.1.1 Implants may have orientation means or sites of shall demonstrate a strength greater than 20 ppi when test
attached fixation materials, or both. specimens made of the same materials and fabricated by
similar techniques are tested in accordance with Dow Corning
5.2 Biocompatibility:
Corporate Test Method CTM 0930.
5.2.1 Biologicaltestingtoensurethesafetyoffacialimplant
devices shall be selected and conducted in accordance with
8. Sterilization
Practices F748 and F981.
8.1 The units may be supplied presterilized in accordance
5.2.2 In addition to biological testing as recommended by
with the United States Pharmacopeia and good manufacturing
Practices F748 and F981, other biological testing may be
practices released by the Food and Drug Administration
appropriate.
(FDA).
6. Dimensions
8.2 Instructions for cleaning and sterilization shall be sup-
6.1 The individual shape, range of sizes, and measurements
plied with the package insert.
are determined by the manufacturer.
6.1.1 Define sizing codes by typical dimensions and
9. Packaging, Labeling, and Package Inserts
volumes, where applicable.
9.1 Packaging (Primary):
7. Mechanical Testing and Test Methods 9
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