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  • ASTM F 703 : 2018

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Specification for Implantable Breast Prostheses

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-10-2022

    Language(s):  English

    Published date:  06-03-2018

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2018 Defines the requirements for silicone gel-filled, saline inflatable silicone gel-filled, and saline inflatable, smooth-shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast.

    Scope - (Show below) - (Hide below)

    1.1This 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.

    1.2Limitations—This specification does not cover custom fabricated implantable breast prostheses.

    1.3Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F2051.

    1.4The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

    1.5This 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.

    1.6This 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 Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 1027 : 1986 : R2017 Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023)
    ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
    ASTM F 2051 : 2000 : R2014 Standard Specification for Implantable Saline Filled Breast Prosthesis
    ASTM D 1349 : 2014 : R2019 Standard Practice for Rubber—Standard Conditions for Testing
    ASTM F 2042 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 1349 : 2014 : REDLINE Standard Practice for Rubber—Standard Conditions for Testing
    ASTM F 2042 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 1349 : 1999 Standard Practice for Rubber-Standard Temperatures For Testing
    ASTM D 1349 : 2009 Standard Practice for Rubber-Standard Temperatures for Testing
    ASTM D 1349 : 2014 Standard Practice for Rubber—Standard Conditions for Testing
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 2051 : 2000 Standard Specification for Implantable Saline Filled Breast Prosthesis
    ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 1349 : 2007 Standard Practice for Rubber-Standard Temperatures for Testing
    ASTM F 2038 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    ASTM F 2038 : 2000 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 2038 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
    ASTM F 2042 : 2018 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    ASTM F 2042 : 2000 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM F 2042 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    ASTM F 2051 : 2000 : R2006 Standard Specification for Implantable Saline Filled Breast Prosthesis
    ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
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