ASTM-F755 2019

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F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

Published By	Publication Date	Number of Pages
ASTM	2019	4

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

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Description

ASTM F755-19

Active Standard: Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

ASTM F755

Scope

1.1 This specification covers the properties and test methods for porous high-density-polyethylene (HDPE) and porous ultra-high-molecular-weight-polyethylene (UHMWPE) 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 non-loaded applications.

1.2 Materials covered by this standard can have a broad range of mechanical and morphological properties depending on the starting material and fabrication processes. Therefore no attempt has been made to standardize the properties, and the requirements for a specific application are not within the scope of this standard.

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

1.4 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 facilitate the establishment of implant fixation.

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

1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

plastic surgical devices/applications; polyethylene (PE) plastics/surgical implant applications; polymers-surgical applicant;

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F0755-19

Additional information

Standard Title	F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Published Code	ASTM
Publication Date	2019
Pages Count	4
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics