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  • ASTM F 2051 : 2000 : R2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Saline Filled Breast Prosthesis

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-10-2022

    Language(s):  English

    Published date:  27-11-2014

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2015 Defines the requirements for single use saline inflatable, smooth and textured silicone 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 single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast.

    1.2Limitations:

    1.2.1This specification does not cover custom fabricated implantable breast prostheses.

    1.2.2This specification does not cover gel/saline type implants, which are within the scope of Specification F703.

    1.3This 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 Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard
    Product Note Reconfirmed 2014
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM G 195 : 2018 Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser
    ASTM F 703 : 2018 Standard Specification for Implantable Breast Prostheses
    ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices
    ASTM F 1441 : 2003 : R2022 Standard Specification for Soft-Tissue Expander Devices
    ASTM F 703 : 2018 : R2022 Standard Specification for Implantable Breast Prostheses
    ASTM G 195 : 2022 Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser

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

    ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
    AAMI ISO 11134 : 1ED 93 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
    ASTM D 1349 : 2014 : R2019 Standard Practice for Rubber—Standard Conditions for Testing
    ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ASTM D 3389 : 2016 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    ASTM D 3389 : 2021 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    ASTM D 3389 : 2010 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    ASTM D 3389 : 2005 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    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 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 3389 : 2015 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    ASTM D 3389 : 2016 : REDLINE Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
    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
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ASTM D 3389 : 1994 : R1999 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform, Double-Head Abrader)
    AAMI ISO 11137 : 94 AMD 1 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
    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 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
    ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
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