ASTM F2051 - 00(2006)

    Standard Specification for Implantable Saline Filled Breast Prosthesis

    Active Standard ASTM F2051 | Developed by Subcommittee: F04.32

    Book of Standards Volume: 13.01


      Format Pages Price  
    PDF 6 $43.00   ADD TO CART
    Hardcopy (shipping and handling) 6 $43.00   ADD TO CART


    Abstract

    This 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. This specification does not cover custom fabricated implantable breast prostheses and other gel-saline type implants. The silicone elastomer compositions for use as primary material of construction of the shell including the exterior (tissue contact) surface shall include: (1) polymer types MQ or VMQ, (2) fillers A, B, or C, (3) additive J (for radiopacity), and (4) catalysts B, G, J, or K. The requirements for the following are specified: (1) fabrication including vulcanization and postcure, (2) volume and dimension of saline filled prostheses, (3) fixation sites, and (4) orientation means. The following tests shall be performed: (1) physical property tests such as shell leakage and tension tests (2) biocompatibility test, (3) shell rupture or failure test, (4) valve competence, and (5) abrasion test. The physical property requirements are specified for (1) shell percent elongation, breaking strength, and tensile set, and (2) critical and non-critical fused or adhered joints. Illustrations for testing fused or adhered joints are provided. Requirements for sterilization, packaging, labeling, and package inserts are detailed as well.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This 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.

    1.2 Limitations

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

    1.2.2 This specification does not cover gel/saline type implants, which are within the scope of Specification F 703.

    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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension

    D1349 Practice for Rubber--Standard Temperatures for Testing

    D3389 Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)

    F604 Specification for Silicone Elastomers Used in Medical Applications

    F703 Specification for Implantable Breast Prostheses

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

    F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

    Other Documents

    FDA Draft Guidance for Preparation of PMA Applications for Silicone Inflatable (Saline) Breast Prostheses Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857, http://www.fda.gov.


    ICS Code

    ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

    UNSPSC Code

    UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)


    DOI: 10.1520/F2051-00R06

    ASTM International is a member of CrossRef.

    ASTM F2051

    Citing ASTM Standards
    Back to Top