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ASTM F881-94(2014)

(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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
30-Sep-2014
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

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 2014)
Standard Specification for
1
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
3
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,
4
United States Pharmacopeia, Volume XX
malar, and ear implants).
5
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
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
3
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.
1
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 Oct. 1, 2014. Published November 2014. Originally
devices shall be selected and conducted in accordance with
approved in 1984. Last previous edition approved in 2006 as F881 – 94 (2006).
Practices F748 and F981.
DOI: 10.1520/F0881-94R14.
2
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
4
Standards volume information, refer to the standard’s Document Summary page on Available from Mack Publishing Co., 1991 N Hampton St. Easton, PA. 18042.
5
the ASTM website. AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
3
The last approved version of this historical standard is referenced on Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
6
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
1

---------------------- Page: 1 ----------------------
F881−94 (2014)
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
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F881 − 94 (Reapproved 2006) F881 − 94 (Reapproved 2014)
Standard Specification for
1
Silicone Elastomer Facial Implants
This standard is issued under the fixed designation F881; 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 (´) indicates an editorial change since the last revision or reapproval.
1. 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 and health practices and determine the applicability of
regulatory limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D2240 Test Method for Rubber Property—Durometer Hardness
3
F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
3
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
2.2 Other Documents:
4
United States Pharmacopeia, Volume XX
5
Federal Register, Title 21, Part 820
Dow Corning Corporate Test Method—CTM 0930—Adhesion—OneHundred Eighty Degree Shear—Thin Elastometric
6
Substrates
3. Terminology
3.1 Definitions:
3.1.1 fixation site—an area on the surface of the implant which has material on it that allows tissue ingrowth.
3.1.2 fused or adhered joints—all junctures of dissimilar materials; and all junctures of fully or partly formed or preformed
materials bonded or fused together to form a single implant unit.
3.1.3 Discussion—Implants made from one material by a single charge of unvulcanized elastomer by one-step compression,
transfer, or reactive injection molding are not considered to have fused or adhered joints.
3.1.4 orientation means—any locus on the surface of the implant that is modified to assist the surgeon to position the implant.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.32 on Plastic and Reconstructive Surgery.
Current edition approved Sept. 1, 2006Oct. 1, 2014. Published September 2006November 2014. Originally approved in 1984. Last previous edition approved in 20002006
as F881 – 94 (2000).(2006). DOI: 10.1520/F0881-94R06.10.1520/F0881-94R14.
2
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 the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
4
Available from Mack Publishing Co., 1991 N Hampton St. Easton, PA. 18042.
5
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
6
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
1

---------------------- Page: 1 ----------------------
F881 − 94 (2014)
4. Significance and Use
4.1 The prostheses described in this specification are intended for implant use in the facial area.
5. Materials
5.1 The primary material of construction shall be fully vulcanized silicone elastomer.
5.1.1 Implants may have orientation means or sites of attached fixation materials, or both.
5.2 Biocompatibility:
5.2.1 Biological testing to ensure the safety of facial implant devices shall be selected and conduct
...

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5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.  
1.7 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.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.  
1.7 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.

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