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ASTM F755-99e1

(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

SCOPE
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 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.

General Information

Status
Historical
Publication Date
09-Aug-1999
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F755-99 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Effective Date
10-Aug-1999
Replaced By
ASTM F755-99(2005) - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Effective Date
01-Mar-2005
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-Aug-1999

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ASTM F755-99e1 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical ImplantsASTM F755-99e1 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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ASTM F755-99e1 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation: F 755 – 99
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Editorial corrections were made in 2.2 and 5.1 in May 2001.
1. Scope D1623 Test Method for Tensile and Tensile Adhesion
2
Properties of Rigid Cellular Plastics
1.1 This specification covers the properties and test meth-
2
D1898 Practice for Sampling of Plastics
ods for porous high density and ultra high molecular weight
D2238 Test Methods for Absorbance of Polyethylene Due
polyethylenesintendedforuseinsurgicalimplants.Theporous
−1 2
to Methyl Groups at 1378 cm
polyethylene may be used as a free standing product or as a
D2873 Test Method for Interior Porosity of Poly(Vinyl
coating on a substrate in nonloaded applications.
Chloride) (PVC) Resins by Mercury Intrusion Porosim-
1.2 Evaluation of tissue response to a porous polyethylene
3
etry
must be completed. Guidance in establishing biocompatibility
E562 Practice for Determining Volume Fraction by Sys-
may be found in the list of references.
4
tematic Manual Point Count
1.3 Clinicalexperienceandanimalstudieshaveshownthat
F316 Test Method for Pore Size Characteristics of Mem-
tissue will grow into the open pores of porous polyethylene.
5
brane Filters for Use with Aerospace Fluids
The tissue ingrowth into the pores may allow for the establish-
F469 Practice for Assessment of Compatibility of Nonpo-
ment of implant fixation.
rous Polymeric Materials for Surgical Implants With Re-
1.4 This section does not purport to address all of the safety
6
gard to Effect of Materials on Tissue
concerns, if any, associated with its use. It is the responsibility
F648 Specification for Ultra-High-Molecular-Weight Poly-
of the user of this standard to establish appropriate safety and
ethylene Powder and Fabricated Form for Surgical Im-
health practices and determine the applicability of regulatory
7
plants
limitations prior to use.
F748 Practice for Selecting Generic Biological Test Meth-
7
2. Referenced Documents ods for Materials and Devices
F763 Practice for Short-Term Screening of Implant Mate-
2.1 ASTM Standards:
7
2
rials
D638 Test Method for Tensile Properties of Plastics
F981 Practice for Assessment of Compatibility of Bioma-
D732 Test Method for Shear Strength of Plastics by Punch
2
terials (Non-porous) for Surgical Implants with Respect to
Tool
7
Effect of Materials on Muscle and Bone
D790 TestMethodsforFlexuralPropertiesofUnreinforced
2.2 Other Documents:
and Reinforced Plastics and Electrical Insulating Materi-
2
Code of Federal Regulations Title 21, Paragraph 177.1520
als
2
U.S. Pharmacopeia, Vol 23, 1995
D883 Definitions of Terms Relating to Plastics
D1238 Test Method for Flow Rates of Thermoplastics by
3. Significance and Use
2
Extrusion Plastometer
3.1 Porous polyethylene is a matrix of substantially open
D1505 Test Method for Density of Plastics by the Density-
2
cells, interconnected to form multidirectional paths. Perfor-
Gradient Technique
mance of these structures, including tissue ingrowth, depends
D1621 Test Method for Compressive Properties of Rigid
2
upon the biocompatibility of the polymer, average pore and
Cellular Plastics
interstitial opening diameters (ordinarily referred to as average
1
This specification is under the jurisdiction of ASTM Committee F04 on
3
Medical and Surgical Materials and Devices and is the direct responsibility of Annual Book of ASTM Standards, Vol 08.02.
4
Subcommittee F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 03.01.
5
Current edition approved August 10, 1999. Published September 1999. Origi- Discontinued—See 1995 Annual Book of Standards, Vol 11.02.
6
nally published as F755–82. Last previous edition F755 –98. Discontinued; See 1985 Annual Book of ASTM Standards, Vol 13.01.
2 7
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
e1
F755–99
poresize)inconjunctionwithvoidvolume(referredtoaspore 5.5 The average pore size shall be specified by vendor-user
volume or percent porosity). agreement and shall be held to within 20% of the nominal
value unless the end-use application requires less deviation.
3.2 Thisspecificationisapplicabletoalldevicestandardsin
5.6 Porous product quality and uniformity shall be assured
which a porous polyethylene is used. A complete list of end
b
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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1.5 The values stated in SI units are to be regarded as the standard.  
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Standard Specification and Test Methods for Metallic Medical Bone Screws

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This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
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SCOPE
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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 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off