• ASTM F 754 : 2008 : R2015

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    Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  05-12-2015

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This specification describes the physical, chemical, and mechanical performance requirements for polytetrafluoroethylene (PTFE) pre-fabricated by compression molding or extrusion into sheet, tube, and rod shapes which may be used for implant products.

    Scope - (Show below) - (Hide below)

    1.1 This specification describes the physical, chemical, and mechanical performance requirements for polytetrafluoroethylene (PTFE) pre-fabricated by compression molding or extrusion into sheet, tube, and rod shapes which may be used for implant products.

    1.2PTFE is a high molecular weight straight chain member of the generic class of perfluorocarbon (containing only the elements fluorine and carbon) polymers.

    1.3 Perfluorocarbon high polymers exhibit extraordinary thermal and chemical stability and do not require stabilizing additives of any kind.

    1.4This specification applies to primarily void-free molded or extruded PTFE shapes formed from granular molding powders. This specification does not apply to shapes formed from “fine powder” resins by lubricated paste extrusion, which includes expanded PTFE.

    1.5This specification does not apply to specific surgical implant products, including their packaging, sterilization, or material boicompatibility and/or suitability for a particular end-use application.

    1.6The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.7This 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 2015
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

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

    ASTM E 1994 : 2009R Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM E 1994 : 2008 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASQ Q9000:2005 Quality Management Systems - Fundamentals And Vocabulary
    ASTM D 4894 : 1998 : REV A Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
    ASTM D 4894 : 2007 Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
    AAMI STBK9 3 : 2001 STERILIZATION - PART 3: INDUSTRIAL PROCESS CONTROL
    ASTM D 3294 : 2015 Standard Specification for Polytetrafluoroethylene (PTFE) Resin Molded Sheet and Molded Basic Shapes
    ASTM D 3294 : 2015 : REDLINE Standard Specification for Polytetrafluoroethylene (PTFE) Resin Molded Sheet and Molded Basic Shapes
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI STBK9 1 : 2001 STERILIZATION - PART 1: STERILIZATION IN HEALTH CARE FACILITIES
    ASTM D 4894 : 2004 Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
    ASTM E 1994 : 1998 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM D 3294 : 1997 Standard Specification for PTFE Resin Molded Sheet and Molded Basic Shapes
    ASTM D 1710 : 2015 : REDLINE Standard Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
    ASTM D 1710 : 2015 Standard Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
    ASTM D 3294 : 2003 Standard Specification for PTFE Resin Molded Sheet and Molded Basic Shapes
    ASTM D 3294 : 2009 Standard Specification for PTFE Resin Molded Sheet and Molded Basic Shapes
    ASTM E 1994 : 2009 : R2013 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM E 1994 : 2009 : R2018 Standard Practice for Use of Process Oriented AOQL and LTPD Sampling Plans
    ASTM D 1710 : 2008 Standard Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
    ANSI/ISO/ASQ Q9001:2008 Quality Management Systems - Requirements
    ASTM D 4894 : 2015 Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
    AAMI STBK9 2 : 2001 STERILIZATION - PART 2: STERILIZATION EQUIPMENT
    ASTM D 4894 : 2019 Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
    ASTM D 4894 : 2007 : R2012 Standard Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials
    ASTM D 1710 : 2002 Standard Specification for Extruded and Compression Molded Polytetrafluoroethylene (PTFE) Rod and Heavy-Walled Tubing
    ASTM D 1710 : 2015 : R2021 Standard Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
    ASTM D 1710 : 1999 Standard Specification for Extruded and Compression Molded Polytetrafluoroethylene (PTFE) Rod and Heavy-Walled Tubing
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