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Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes
STANDARD published on 10.5.2000
Designation standards: ASTM F754-00
Note: WITHDRAWN
Publication date standards: 10.5.2000
SKU: NS-56348
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
Fluoropolymers-PTFE (polytetrafluoroethylene), Implants, Plastic surgical devices/applications, Polymers-surgical applications, implantable polytetrafluoroethylene (PTFE) polymer (in sheet/tube/rod, shapes), spec, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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. |
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2. Referenced Documents | ||||||||||||||||||||||
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