ASTM-F755 2011

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F755-99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

Published By	Publication Date	Number of Pages
ASTM	2011	3

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications.

1.2 Evaluation of tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.

1.3 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may allow for the establishment of implant fixation.

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

1.5 This section 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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PDF Pages	PDF Title
1	Scope Referenced Documents Significance and Use
2	Raw Material Requirements Product Requirements Test Methods Certification Keywords
3	X1. RATIONALE X1.1 X1.2 X1.3 X2. BIOCOMPATIBILITY X2.1 X2.2

Additional information

Standard Title	F755-99(2011) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Published Code	ASTM
Publication Date	2011
Pages Count	3
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F755 2011

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