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ASTM F881-94(2000)

(Specification)

Standard Specification for Silicone Elastomer Facial Implants

Standard Specification for Silicone Elastomer Facial Implants

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 problems, 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-Dec-1999
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

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

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ASTM F881-94(2000) - Standard Specification for Silicone Elastomer Facial ImplantsASTM F881-94(2000) - Standard Specification for Silicone Elastomer Facial Implants
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ASTM F881-94(2000) - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 881 – 94 (Reapproved 2000)
Standard Specification for
Silicone Elastomer Facial Implants
This standard is issued under the fixed designation F 881; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope Federal Register, Title 21,Part 820
Dow Corning Corporate Test Method— CTM 0930—
1.1 This specification covers the requirements for silicone
Adhesion—OneHundred Eighty Degree Shear—Thin
elastomer implants used in facial surgery (that is, chin, nasal,
Elastometric Substrates
malar, and ear implants).
1.2 Limitations—This specification does not cover implants
3. Terminology
containing silicone gels or other gels or liquids. It does not
3.1 Definitions:
necessarily cover any custom-fabricated prosthesis manufac-
3.1.1 fixation site—an area on the surface of the implant
tured to any other specification.
which has material on it that allows tissue ingrowth.
1.3 The following safety hazards caveat pertains only to the
3.1.2 fused or adhered joints—all junctures of dissimilar
mechanical testing and test methods portion, Section 7, of this
materials; and all junctures of fully or partly formed or
specification: This standard does not purport to address all of
preformed materials bonded or fused together to form a single
the safety problems, if any, associated with its use. It is the
implant unit.
responsibility of the user of this standard to establish appro-
3.1.3 Discussion—Implants made from one material by a
priate safety and health practices and determine the applica-
single charge of unvulcanized elastomer by one-step compres-
bility of regulatory limitations prior to use.
sion, transfer, or reactive injection molding are not considered
2. Referenced Documents to have fused or adhered joints.
3.1.4 orientation means—any locus on the surface of the
2.1 ASTM Standards:
implant that is modified to assist the surgeon to position the
D 412 Test Methods for Rubber Properties in Tension
implant.
D 624 Test Method for Rubber Property—Tear Resistance
D 2240 Test Method for Rubber Property—Durometer
4. Significance and Use
Hardness
4.1 The prostheses described in this specification are in-
F 604 Classification for Silicone Elastomers Used in Medi-
3 tended for implant use in the facial area.
cal Applications
F 748 Practice for Selecting Generic Biological Test Meth-
5. Materials
ods for Materials and Devices
5.1 The primary material of construction shall be fully
F 981 Practice for Assessment of Compatibility of Bioma-
vulcanized silicone elastomer.
terials for Surgical Implants with Respect to Effect of
4 5.1.1 Implants may have orientation means or sites of
Materials on Muscle and Bone
attached fixation materials, or both.
F 1251 Terminology Relating to Polymeric Biomaterials in
4 5.2 Biocompatibility:
Medical and Surgical Devices
5.2.1 Biologicaltestingtoensurethesafetyoffacialimplant
2.2 Other Documents:
5 devices shall be selected and conducted in accordance with
United States Pharmacopeia, Volume XX
Practices F 748 and F 981.
5.2.2 In addition to biological testing as recommended by
Practices F 748 and F 981, other biological testing may be
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
appropriate.
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
Current edition approved May 15, 1994. Published July 1994. Originally
published as F 881 – 84. Last previous edition F 881 – 84.
2 6
Annual Book of ASTM Standards, Vol 09.01. AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
Discontinued; See 2000 Annual Book of ASTM Standards, Vol 13.01. Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
4 7
Annual Book of ASTM Standards, Vol 13.01. Available from Dow Corning Corp., Midland, MI 48686-0994 Phone: (517)
Available from Mack Publishing Co., 1991 N Hampton St. Easton, PA. 18042. 496-5461
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 881 – 94 (2000)
6. Dimensions 8. Sterilization
6.1 The individual shape, range of sizes, and measurements 8.1 The units may be supplied presterilized in accordance
are determined by the manufacturer. with the United States Pharmacopeia and good manufacturing
6.1.1 Define sizing codes by typical dimensions and vol- practices released by the Food and Drug Administration
umes, where applicable. (FDA).
8.2 Instructions for cleaning and sterilization shall be sup-
7. Mechanical Testing and Test Methods
plied with the package insert.
7.1 Typical Physical Properties of Elastomers:
9. Packaging, Labeling, and Package Inserts
7.1.1 Elongation at Failure—The elongation at failure shall
be 200 %, minimum, when tested in accordance with Test 9.1 Packaging (Primary):
Methods D 412. 9.1.1 Packages shall be sealed to prevent contamination and
7.1.2 Durometer—The durometer shall have a maximum of to maintain sterility.
shore A80, depending on application, when tested in accor- 9.1.2 Units shall be packaged with suitable containers that
dance with Test Method D 2240. will prevent damage in transit.
7.1.3 Tensile St
...

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