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Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants (Includes all amendments And changes 12/31/2010).
Automatische name übersetzung:
Standard-Spezifikation für ultra-hochmolekulares Polyethylen Pulver und Zeugform für chirurgische Implantate
NORM herausgegeben am 1.2.2007
Bezeichnung normen: ASTM F648-07e1
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 1.2.2007
SKU: NS-56005
Zahl der Seiten: 8
Gewicht ca.: 24 g (0.05 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Keywords:
fabricated forms, powdered form, ultra-high molecular weight polyethylene, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics), 83.080.20 (Thermoplastic materials)
1. Scope | ||||||||||||||||||||||||||||||||
1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants. 1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. 1.3 The provisions of Specification D 4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants. 1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3) and by laboratory studies (4,5 6, ). The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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.<> |
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2. Referenced Documents | ||||||||||||||||||||||||||||||||
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