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ASTM F703-07

(Specification)

Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)

Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)

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.This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. Breast prosthesis are classified into three types: type I breast prosthesis, n - implantable breast prosthesis containing a single lumen containing a fixed amount of silicone gel, Type II breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other, and type III breast prosthesis, n - implantable breast prosthesis comprised of two complete lumens, one inside the other. Elongation, breaking strength, tensile set, critical fused or adhered joints, shell rupture, and shell leakage shall be tested to meet the requirements prescribed. Gel cohesion, gel bleeding, and gel penetration shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses.
1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F 2051.
1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.
1.5 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.
WITHDRAWN RATIONALE
This specification covered the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2016 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Historical
Publication Date
31-Mar-2007
Withdrawal Date
13-Jan-2016
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 F703-96(2002)e1 - Standard Specification for Implantable Breast Prostheses
Effective Date
01-Apr-2007
Referred By
ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
Effective Date
01-Apr-2007
Referred By
ASTM F2051-00(2022) - Standard Specification for Implantable Saline-Filled Breast Prostheses
Effective Date
01-Apr-2007

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ASTM F703-07 - Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)ASTM F703-07 - Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)
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ASTM F703-07 - Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)
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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:F703 −07
StandardSpecification for
1
Implantable Breast Prostheses
ThisstandardisissuedunderthefixeddesignationF703;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 F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
in Medical Applications Part II—Crosslinking and Fabri-
1.1 This specification covers the requirements for silicone
cation
gel-filled and saline-inflatable silicone gel-filled implantable
F2051 Specification for Implantable Saline Filled Breast
breast prostheses intended for use in surgical reconstruction,
Prosthesis
augmentation, or replacement of the breast.
2.2 Other Documents:
1.2 Limitations—This specification does not cover custom
Saline, Silicone Gel, and Alternative Breast Implants—
fabricated implantable breast prostheses.
Guidance for Industry and FDA Staff, November 17,
4
1.3 Single-use saline-inflatable, smooth, and textured sili- 2006
ISO/AAMI/ANSI10993-1 BiologicalEvaluationofMedical
cone shell implantable breast prostheses are addressed in
5
Specification F2051. Devices—Part 1: Evaluation and Testing
1.4 The values stated in SI units are to be regarded as the
3. Terminology
standard. The inch-pound units given in parentheses are for
3.1 Definitions:
information only.
3.1.1 barrier coat, n—a silicone elastomer layer that is part
1.5 This standard does not purport to address all of the
of the shell of a silicone gel implantable breast prosthesis that
safety concerns, if any, associated with its use. It is the
retards silicone bleed.
responsibility of the user of this standard to establish appro-
3.1.2 fixation site, n—an area of the shell of an implantable
priate safety and health practices and determine the applica-
breast prosthesis containing material that allows tissue in-
bility of regulatory limitations prior to use.
growth.
2. Referenced Documents
3.1.3 fused or adhered joints (seams), n— sites in the shell
2
or other parts of an implantable breast prosthesis where
2.1 ASTM Standards:
materials have been joined (fused or bonded) together, with or
D412 Test Methods forVulcanized Rubber andThermoplas-
without an adhesive, as part of the manufacturing process.
tic Elastomers—Tension
D1349 Practice for Rubber—Standard Conditions for Test-
3.1.4 gel bleed, n—diffusion of liquid silicone components
ing
of silicone gel through the shell of an implantable breast
F748 PracticeforSelectingGenericBiologicalTestMethods
prosthesis.
for Materials and Devices
3.1.5 gel-filled breast prosthesis, n—implantable breast
F1251 Terminology Relating to Polymeric Biomaterials in
prosthesis designed and provided with a pre-filled, fixed
3
Medical and Surgical Devices (Withdrawn 2012)
volume of silicone gel.
F2038 GuideforSiliconeElastomers,Gels,andFoamsUsed
3.1.5.1 Type I breast prosthesis, n—implantable breast pros-
in Medical Applications Part I—Formulations and Un-
thesis containing a single lumen containing a fixed amount of
cured Materials
silicone gel.
(1) Discussion—The lumen of a Type I breast prostheses is
1
This specification is under the jurisdiction of ASTM Committee F04 on
not accessible for volume adjustments of any kind.
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1.5.2 Type II breast prosthesis, n—implantable breast
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
Current edition approved April 1, 2007. Published May 2007. Originally prosthesis comprised of two complete lumens, one inside the
ε1
approved in 1981. Last previous edition approved in 2002 as F703 – 96 (2002) .
other.
DOI: 10.1520/F0703-07.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from U.S. Department of Health and Human Services, Food and
Standards volume information, refer to the standard’s Document Summary page on Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://
the ASTM website. www.fda.gov/cdrh/ode/guidance/1239.
3 5
The last approved version of this historical standard is referenced on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
www.astm.org. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F703−07
(1) Discussion—The inner lumen of a Type II implantable 4.1.1 This specification is not intended to limit the science
breast prosthesis contains a fixed amount of silicone gel and is andtechnologywhichmaybeconsideredandappliedtoen
...

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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. 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.  
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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.  
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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.

  • Technical specification
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  • Technical specification
    22 pages
    English language
    sale 15% off