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This specification describes the physical and chemical property, biocompatibility, and sterility requirements for polytetrafluoroethylene (PTFE) polymers fabricated in sheet, tube, and rod shapes that may be used for surgical implants. It ensures the absence of adulterants, additives, processing aids, or extractable organic contaminants from fabricated configurations. It does not apply to specific surgical implants, would instead be subjected to appropriate end-use performance standards.
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.
Significance and Use
Fabricated PTFE meeting the requirements of this specification can be expected to exhibit consistent and reproducible chemical, physical, and biological properties.
This specification provides an analytic method to extract organic contaminants from fabricated configurations, which includes a limit to the presence of residual adulterants, additives, or processing aids.
This specification addresses the characteristics of virgin raw granular molding powders obtained from resin manufacturers and used for producing implant configurations.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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 StandardsAAMISTBK9–3 Sterilization--Part 3: Industrial Process Control
ANSI StandardsANSI/ISO/ASQQ9001 Quality Management Systems--Requirements
ISO StandardsISO10993 Biological Evaluation of Medical Devices
U. S. Code of Federal Regulations21CFR820 Quality System Regulation
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products); 13102008(Fluoropolymers PTFE)