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ASTM F703-18(2022)

(Specification)

Standard Specification for Implantable Breast Prostheses

Standard Specification for Implantable Breast Prostheses

ABSTRACT
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 F2051.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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

Status
Published
Publication Date
30-Sep-2022
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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ASTM F703-18(2022) - Standard Specification for Implantable Breast ProsthesesASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
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ASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
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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: F703 −18 (Reapproved 2022)
Standard Specification 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 F1251 Terminology Relating to Polymeric Biomaterials in
3
Medical and Surgical Devices (Withdrawn 2012)
1.1 This specification covers the requirements for silicone
F2038 GuideforSiliconeElastomers,Gels,andFoamsUsed
gel-filled and saline-inflatable silicone gel-filled implantable
in Medical Applications Part I—Formulations and Un-
breast prostheses intended for use in surgical reconstruction,
cured Materials
augmentation, or replacement of the breast.
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
1.2 Limitations—This specification does not cover custom
in Medical Applications Part II—Crosslinking and Fabri-
fabricated implantable breast prostheses.
cation
1.3 Single-use saline-inflatable, smooth and textured sili- F2051 Specification for Implantable Saline Filled Breast
Prosthesis
cone shell implantable breast prostheses are addressed in
Specification F2051. 2.2 Other Documents:
Guidance for Industry and FDA Staff Saline, Silicone Gel,
1.4 The values stated in SI units are to be regarded as the
4
and Alternative Breast Implants, November 17, 2006
standard. The inch-pound units given in parentheses are for
ISO/AAMI/ANSI10993-1 BiologicalEvaluationofMedical
information only.
5
Devices—Part 1: Evaluation and Testing
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3. Terminology
responsibility of the user of this standard to establish appro-
3.1 Definitions:
priate safety, health, and environmental practices and deter-
3.1.1 barrier coat, n—a silicone elastomer layer that is part
mine the applicability of regulatory limitations prior to use.
of the shell of a silicone gel implantable breast prosthesis that
1.6 This international standard was developed in accor-
retards silicone bleed.
dance with internationally recognized principles on standard-
3.1.2 fixation site, n—an area of the shell of an implantable
ization established in the Decision on Principles for the
breast prosthesis containing material that allows tissue in-
Development of International Standards, Guides and Recom-
growth.
mendations issued by the World Trade Organization Technical
3.1.3 fused or adhered joints (seams), n—sitesintheshellor
Barriers to Trade (TBT) Committee.
other parts of an implantable breast prosthesis where materials
2. Referenced Documents
havebeenjoined(fusedorbonded)together,withorwithoutan
2
adhesive, as part of the manufacturing process.
2.1 ASTM Standards:
D412 Test Methods forVulcanized Rubber andThermoplas-
3.1.4 gel bleed, n—diffusion of liquid silicone components
tic Elastomers—Tension
of silicone gel through the shell of an implantable breast
D1349 Practice for Rubber—Standard Conditions for Test-
prosthesis.
ing
3.1.5 gel-filled breast prosthesis, n—implantable breast
F748 PracticeforSelectingGenericBiologicalTestMethods
prosthesis designed and provided with a pre-filled, fixed
for Materials and Devices
volume of silicone gel.
3.1.5.1 Type I breast prosthesis, n—implantable breast pros-
1
This specification is under the jurisdiction of ASTM Committee F04 on
thesis containing a single lumen containing a fixed amount of
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.32 on Plastic and Reconstructive Surgery.
3
Current edition approved Oct. 1, 2022. Published October 2022. Originally The last approved version of this historical standard is referenced on
approved in 1981. Last previous edition approved in 2018 as F703 – 18. DOI: www.astm.org.
4
10.1520/F0703-18R22. Available from U.S. Department of Health and Human Services, Food and
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.fda.gov/cdrh/ode/guidance/1239.
5
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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

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A1.1 Significance and Use
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SCOPE
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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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.  
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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.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
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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Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
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4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
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1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
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 ...

  • Guide
    34 pages
    English language
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  • Guide
    34 pages
    English language
    sale 15% off