ASTM F755-19
(Specification)Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
ABSTRACT
This specification covers the raw material and final product requirements, and the associated test methods for the selection of 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. Physical properties such as pore size and volume, as well as tensile, compressive, flexural, and shear properties shall be determined, but will be specified in the particular device to which its end use shall be applied.
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.
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Standards Content (Sample)
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.
Designation: F755 −19
Standard Specification for
Selection of Porous Polyethylene for Use in Surgical
1
Implants
ThisstandardisissuedunderthefixeddesignationF755;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 Thisspecificationcoversthepropertiesandtestmethods
for porous high-density-polyethylene (HDPE) and porous
2. Referenced Documents
ultra-high-molecular-weight-polyethylene (UHMWPE) in-
2
2.1 ASTM Standards:
tended for use in surgical implants. The porous polyethylene
may be used as a free-standing product or as a coating on a D638Test Method for Tensile Properties of Plastics
D732Test Method for Shear Strength of Plastics by Punch
substrate in non-loaded applications.
Tool
1.2 Materials covered by this standard can have a broad
D790Test Methods for Flexural Properties of Unreinforced
range of mechanical and morphological properties depending
and Reinforced Plastics and Electrical Insulating Materi-
onthestartingmaterialandfabricationprocesses.Thereforeno
als
attempt has been made to standardize the properties, and the
D883Terminology Relating to Plastics
requirementsforaspecificapplicationarenotwithinthescope
D1238Test Method for Melt Flow Rates of Thermoplastics
of this standard.
by Extrusion Plastometer
1.3 Evaluation of the tissue response to a porous polyeth-
D1505Test Method for Density of Plastics by the Density-
ylenemustbecompleted.Guidanceinestablishingbiocompat-
Gradient Technique
ibility may be found in the list of references.
D1621Test Method for Compressive Properties of Rigid
Cellular Plastics
1.4 Clinical experience and animal studies have shown that
D1623Test Method for Tensile and TensileAdhesion Prop-
tissue will grow into the open pores of porous polyethylene.
The tissue ingrowth into the pores may facilitate the establish- erties of Rigid Cellular Plastics
3
D1898Practice for Sampling of Plastics (Withdrawn 1998)
ment of implant fixation.
D2238TestMethodsforAbsorbanceofPolyethyleneDueto
1.5 The values stated in SI units are to be regarded as
−1
Methyl Groups at 1378 cm
standard. No other units of measurement are included in this
E562Test Method for Determining Volume Fraction by
standard.
Systematic Manual Point Count
1.6 This standard does not purport to address all of the
F648Specification for Ultra-High-Molecular-Weight Poly-
safety concerns, if any, associated with its use. It is the
ethylene Powder and Fabricated Form for Surgical Im-
responsibility of the user of this standard to establish appro-
plants
priate safety, health, and environmental practices and deter-
F748PracticeforSelectingGenericBiologicalTestMethods
mine the applicability of regulatory limitations prior to use.
for Materials and Devices
1.7 This international standard was developed in accor-
F981Practice for Assessment of Compatibility of Biomate-
dance with internationally recognized principles on standard-
rials for Surgical Implants with Respect to Effect of
ization established in the Decision on Principles for the
Materials on Muscle and Insertion into Bone
Development of International Standards, Guides and Recom-
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Dec. 1, 2019. Published January 2020. Originally the ASTM website.
3
approved in 1982. Last previous edition approved in 2011 as F755 –99 (2011). The last approved version of this historical standard is referenced on
DOI: 10.1520/F0755-19. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F755 − 19
F2450Guide for Assessing Microstructure of Polymeric 4.7 The polymer shall be characterized by one or more of
Scaffolds for Use in Tissue-Engineered Medical Products the following test methods:
4
4.7.1 Thepolymershallbecharacterizedbydeterminingthe
2.2 ISO Standards:
melt point range and rate of melt by thermal analysis.
ISO 10993-1Biological Evaluation of Medical Devices—
4.7.2 Thecompositional
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F755 − 99 (Reapproved 2011) F755 − 19
Standard Specification for
Selection of Porous Polyethylene for Use in Surgical
1
Implants
This standard is issued under the fixed designation F755; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification covers the properties and test methods for porous high density and ultra high molecular weight
polyethylenes 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 free-standing product or as a coating on a
substrate in nonloadednon-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 allow for 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 sectionstandard 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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D638 Test Method for Tensile Properties of Plastics
D732 Test Method for Shear Strength of Plastics by Punch Tool
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D883 Terminology Relating to Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1621 Test Method for Compressive Properties of Rigid Cellular Plastics
D1623 Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
−1
D2238 Test Methods for Absorbance of Polyethylene Due to Methyl Groups at 1378 cm
D2873 Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry (Withdrawn
3
2003)
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Dec. 1, 2011Dec. 1, 2019. Published January 2012January 2020. Originally approved in 1982. Last previous edition approved in 20052011 as
F755 – 99 (2005).(2011). DOI: 10.1520/F0755-99R11. 10.1520/F0755-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F755 − 19
E562 Test Method for Determining Volume Fraction by Systematic Manual Point Count
F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748 Prac
...
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