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ASTM F 754 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-10-2008

CONTAINED IN VOL. 13.01, 2015 Specifies 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.

1.2 PTFE 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.

1.4 This 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.

1.5 This 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.

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

1.7 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.

Committee
F 04
DocumentType
Standard
Pages
4
ProductNote
Reconfirmed 2008
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASQ Q9000:2005 Quality Management Systems - Fundamentals And Vocabulary
AAMI STBK9 3 : 2001 STERILIZATION - PART 3: INDUSTRIAL PROCESS CONTROL
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 1710 : 2015 : REDLINE Standard Specification for Extruded Polytetrafluoroethylene (PTFE) Rod, Heavy Walled Tubing and Basic Shapes
ANSI/ISO/ASQ Q9001:2008 Quality Management Systems - Requirements
AAMI STBK9 2 : 2001 STERILIZATION - PART 2: STERILIZATION EQUIPMENT

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