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  • ASTM
    F754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes
    Edition: 2000
    $91.10
    Unlimited Users per year

Description of ASTM-F754 2000

ASTM F754-00

Historical Standard: ASTM F754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes

SUPERSEDED (see Active link, below)




ASTM F754

1. Scope

1.1 This specification describes the performance of polytetrafluoroethylene (PTFE) fabricated in sheet, tube, and rod shapes which may be used for surgical implants. PTFE is a member of the generic class of perfluorocarbon (containing only the elements fluorine and carbon) polymers.

1.2 Perfluorocarbon high polymers are solids exhibiting extraordinary thermal and chemical stability. They do not require stabilizing additives of any kind.

1.3 The biological response to PTFE in soft tissue and bone has been well characterized by a history of clinical use and animal studies (1-9).

1.4 This specification does not apply to specific surgical implants. Such implants would be subject to appropriate end-use performance standards.


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

D1710 Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes

D3294 Specification for Polytetrafluoroethylene (PTFE) Resin Molded Sheet and Molded Basic Shapes

D4894 Specification for Polytetrafluoroethylene (PTFE) Granular Molding and Ram Extrusion Materials

E1994 Practice for Use of Process Oriented AOQL and LTPD Sampling Plans

AAMI Standards

AAMISTBK93 Sterilization--Part 3: Industrial Process Control

ANSI Standards

ANSI/ISO/ASQQ9001 Quality Management Systems--Requirements

ISO Standards

ISO10993 Biological Evaluation of Medical Devices

U. S. Code of Federal Regulations

21CFR820 Quality System Regulation

Keywords

perfluorocarbon; polytetrafluoroethylene; PTFE; surgical implant; Implantable surgical materials/applications; Plastic surgical devices/applications--specifications; Polymers--surgical applications (specifications); PTFE (polytetrafluoroethylene)--surgical implant specifications; Surgical implants--specifications ;


ICS Code

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


DOI: 10.1520/F0754-00

ASTM International is a member of CrossRef.


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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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