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

12-05-2015

Publisher

American Society for Testing and Materials

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.

1.1 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.

Committee	F 04
DocumentType	Standard
Pages	4
ProductNote	Reconfirmed 2015
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM F 754 : 2008

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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
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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
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ASTM D 3294 : 2003	Standard Specification for PTFE Resin Molded Sheet and Molded Basic Shapes
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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