ASTM F561-05a(2010)
(Practice)Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
SIGNIFICANCE AND USE
The investigation of retrieved implantable medical devices and adjacent tissues can be of value in the assessment of clinical complications associated with the use of a specific prosthetic device design; can expand the knowledge of clinical implant performance and interactions between implants and the body; provide information on implant performance and safety; and thus further the development of biocompatible implant materials and devices with improved performance. Comparison of wear patterns and wear particle morphology observed with retrievals and those observed with in vitro joint simulator tests can provide valuable insight into the validity of the in vitro simulation.
A significant portion of the information associated with a retrieved implant is obtained with detailed studies of the device-tissue interface. Appropriate methods are provided to facilitate a study of the particles in the tissues, and chemical analysis for the byproducts of degradation of the implant, and histologic evaluation of the cellular response to the implant.
For the analysis to be accurate, it is essential that the device and associated tissues be removed without alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial contamination of the work place or the investigator. Standard protocols for the examination and collection of data are provided for retrieval and handling of implantable medical devices, as well as for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate procedures must be specified.
In order to interpret the analysis of materials and tissues, it is also essential to capture a minimum data set regarding the clinical findings and laboratory studies documenting device performance and reasons for removal.
Any destructive analysi...
SCOPE
1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies. This practice can also be used for analysis of specimens and lubrication fluids from in vitro wear tests and joint simulators. The aim is to provide guidance in preventing damage to the associated specimens which could obscure the investigational results, and in gathering data at the proper time and circumstance to validate the study.
1.2 This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard protocols for the examination and collection of data are provided for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate handling procedures must be specified.
1.3 This practice recommendation should be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as per Practice E860.
1.4 A significant portion of the information associated with a retrieved implant device is often at the device-tissue interface or in the tissues associated with the implant and related organ systems. Attention should be given to the handling of adjacent tissues, so as not to interfere with study of the particles in the adjacent tissue, a chemical analys...
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Designation: F561 − 05a(Reapproved 2010)
Standard Practice for
Retrieval and Analysis of Medical Devices, and Associated
Tissues and Fluids
ThisstandardisissuedunderthefixeddesignationF561;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope adjacent tissue, a chemical analysis for the byproducts of
degradation of the implant, or a study of the cellular response
1.1 This practice covers recommendations for the retrieval,
to the implant.
handling, and analysis of implanted medical devices and
1.5 The values stated in SI units are to be regarded as
associated specimens that are removed from patients during
standard. No other units of measurement are included in this
revision surgery, at postmortem, or as part of animal studies.
standard.
This practice can also be used for analysis of specimens and
lubrication fluids from in vitro wear tests and joint simulators. 1.6 This standard may involve hazardous materials,
operations, and equipment. As a precautionary measure, ex-
The aim is to provide guidance in preventing damage to the
associated specimens which could obscure the investigational planteddevicesshouldbesterilizedorminimallydisinfectedby
an appropriate means that does not adversely affect the
results, and in gathering data at the proper time and circum-
implant or the associated tissue that may be subject to
stance to validate the study.
subsequent analysis. A detailed discussion of precautions to be
1.2 This practice offers guidelines for the analysis of re-
used in handling of human tissues can be found in ISO
trieved implants to limit damage to them, and to allow
12891-1. This standard does not purport to address all of the
comparisons between investigational results from different
safety concerns, if any, associated with its use. It is the
studies. The protocols are divided into three stages, where
responsibility of the user of this standard to establish appro-
Stage I is the minimum non-destructive analysis, Stage II is
priate safety and health practices and determine the applica-
more complete non-destructive analysis, and Stage III is
bility of regulatory limitations prior to use.
destructive analysis. Standard protocols for the examination
and collection of data are provided for specific types of
2. Referenced Documents
materialsinrelationtotheirtypicalapplications.Forparticular
2.1 ASTM Standards:
investigational programs, additional, more specific, protocols
A262Practices for Detecting Susceptibility to Intergranular
mayberequired.Ifspecialanalyticaltechniquesareemployed,
Attack in Austenitic Stainless Steels
the appropriate handling procedures must be specified.
A751Test Methods, Practices, and Terminology for Chemi-
1.3 This practice recommendation should be applied in cal Analysis of Steel Products
C20Test Methods forApparent Porosity, WaterAbsorption,
accordance with national regulations or legal requirements
Apparent Specific Gravity, and Bulk Density of Burned
regarding the handling and analysis of retrieved implants and
Refractory Brick and Shapes by Boiling Water
excised tissues, especially with regard to handling devices
C158Test Methods for Strength of Glass by Flexure (De-
whichmaybecomeinvolvedinlitigation,asperPracticeE860.
termination of Modulus of Rupture)
1.4 Asignificant portion of the information associated with
C169Test Methods for Chemical Analysis of Soda-Lime
aretrievedimplantdeviceisoftenatthedevice-tissueinterface
and Borosilicate Glass
or in the tissues associated with the implant and related organ
C573Methods for ChemicalAnalysis of Fireclay and High-
systems.Attention should be given to the handling of adjacent
Alumina Refractories (Withdrawn 1995)
tissues, so as not to interfere with study of the particles in the
C623Test Method for Young’s Modulus, Shear Modulus,
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2010. Published November 2010. Originally the ASTM website.
approved 1978. Last previous edition approved in 2005 as F561–05a. DOI: The last approved version of this historical standard is referenced on
10.1520/F0561-05AR10. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F561 − 05a (2010)
and Poisson’s Ratio for Glass and Glass-Ceramics by D1621Test Method for Compressive Properties of Rigid
Resonance Cellular Plastics
C633Test Method for Adhesion or Cohesion Strength of D1622Test Method for Apparent Density of Rigid Cellular
Plastics
Thermal Spray Coatings
D1623Test Method for Tensile and TensileAdhesion Prop-
C674Test Methods for Flexural Properties of Ceramic
erties of Rigid Cellular Plastics
Whiteware Materials
D1708TestMethodforTensilePropertiesofPlasticsbyUse
C730Test Method for Knoop Indentation Hardness of Glass
of Microtensile Specimens
C1069Test Method for Specific SurfaceArea ofAlumina or
D2240TestMethodforRubberProperty—DurometerHard-
Quartz by Nitrogen Adsorption
ness
C1161Test Method for Flexural Strength of Advanced
D2842Test Method for Water Absorption of Rigid Cellular
Ceramics at Ambient Temperature
Plastics
C1198Test Method for Dynamic Young’s Modulus, Shear
D2857Practice for Dilute Solution Viscosity of Polymers
Modulus, and Poisson’s Ratio forAdvanced Ceramics by
D2873Test Method for Interior Porosity of Poly(Vinyl
Sonic Resonance
Chloride) (PVC) Resins by Mercury Intrusion Porosim-
C1322Practice for Fractography and Characterization of
etry (Withdrawn 2003)
Fracture Origins in Advanced Ceramics
D2990Test Methods forTensile, Compressive, and Flexural
C1326Test Method for Knoop Indentation Hardness of
Creep and Creep-Rupture of Plastics
Advanced Ceramics
D3016Practice for Use of Liquid Exclusion Chromatogra-
C1327Test Method for Vickers Indentation Hardness of
phy Terms and Relationships
Advanced Ceramics
D3417Test Method for Enthalpies of Fusion and Crystalli-
D256Test Methods for Determining the Izod Pendulum
zation of Polymers by Differential Scanning Calorimetry
Impact Resistance of Plastics
(DSC) (Withdrawn 2004)
D412TestMethodsforVulcanizedRubberandThermoplas-
D3418Test Method for Transition Temperatures and En-
tic Elastomers—Tension
thalpies of Fusion and Crystallization of Polymers by
D570Test Method for Water Absorption of Plastics
Differential Scanning Calorimetry
D621Specification for Jute Rove and Plied Yarn for Elec-
D3835Test Method for Determination of Properties of
trical and Packing Purposes (Withdrawn 2000)
Polymeric Materials by Means of a Capillary Rheometer
D624Test Method for Tear Strength of Conventional Vul-
D3919Practice for Measuring Trace Elements in Water by
canized Rubber and Thermoplastic Elastomers
Graphite Furnace Atomic Absorption Spectrophotometry
D638Test Method for Tensile Properties of Plastics
D4000Classification System for Specifying Plastic Materi-
D671Test Method for Flexural Fatigue of Plastics by
als
Constant-Amplitude-of-Force (Withdrawn 2002)
D4001Test Method for Determination of Weight-Average
D695Test Method for Compressive Properties of Rigid
Molecular Weight of Polymers By Light Scattering
Plastics
D4065Practice for Plastics: Dynamic Mechanical Proper-
D732Test Method for Shear Strength of Plastics by Punch
ties: Determination and Report of Procedures
Tool
D4754Test Method for Two-Sided Liquid Extraction of
D747Test Method for Apparent Bending Modulus of Plas-
Plastic Materials Using FDA Migration Cell
tics by Means of a Cantilever Beam
D5152PracticeforWaterExtractionofResidualSolidsfrom
D785Test Method for Rockwell Hardness of Plastics and 3
DegradedPlasticsforToxicityTesting(Withdrawn1998)
Electrical Insulating Materials
D5227TestMethodforMeasurementofHexaneExtractable
D790Test Methods for Flexural Properties of Unreinforced
Content of Polyolefins
and Reinforced Plastics and Electrical Insulating Materi-
D5296Test Method for Molecular Weight Averages and
als
Molecular Weight Distribution of Polystyrene by High
D792Test Methods for Density and Specific Gravity (Rela-
Performance Size-Exclusion Chromatography
tive Density) of Plastics by Displacement
E3Guide for Preparation of Metallographic Specimens
D1004Test Method for Tear Resistance (Graves Tear) of
E7Terminology Relating to Metallography
Plastic Film and Sheeting
E8Test Methods for Tension Testing of Metallic Materials
D1042Test Method for Linear Dimensional Changes of
E10Test Method for Brinell Hardness of Metallic Materials
Plastics Under Accelerated Service Conditions
E18Test Methods for Rockwell Hardness of Metallic Ma-
D1238Test Method for Melt Flow Rates of Thermoplastics
terials
by Extrusion Plastometer
E45Test Methods for Determining the Inclusion Content of
D1239Test Method for Resistance of Plastic Films to
Steel
Extraction by Chemicals
E92TestMethodforVickersHardnessofMetallicMaterials
D1242Test Methods for Resistance of Plastic Materials to (Withdrawn 2010)
Abrasion (Withdrawn 2003) E112Test Methods for Determining Average Grain Size
D1505Test Method for Density of Plastics by the Density-
E120Test Methods for Chemical Analysis of Titanium and
Gradient Technique Titanium Alloys (Withdrawn 2003)
F561 − 05a (2010)
E135Terminology Relating to Analytical Chemistry for 2.2 Other Document:
Metals, Ores, and Related Materials ISO12891-1,RetrievalandAnalysisofImplantableMedical
Devices, Part 1: Standard Practice for Retrieval and
E168Practices for General Techniques of Infrared Quanti-
Handling
tative Analysis
E204Practices for Identification of Material by Infrared
3. Terminology
Absorption Spectroscopy, Using the ASTM Coded Band
and Chemical Classification Index 3.1 Definition of Terms Specific to Issues of Microbial
Contamination:
E290Test Methods for Bend Testing of Material for Ductil-
3.1.1 antiseptic—a germicide that is used on skin or living
ity
tissue for the purposes of inhibiting or destroying microorgan-
E353Test Methods for Chemical Analysis of Stainless,
isms.
Heat-Resisting, Maraging, and Other Similar Chromium-
Nickel-Iron Alloys 3.1.2 decontamination—a process or treatment that renders
a medical device, instrument, or environmental surface safe to
E354 Test Methods for Chemical Analysis of High-
handle. Ranges from sterilization to cleaning with soap and
Temperature,Electrical,Magnetic,andOtherSimilarIron,
water.
Nickel, and Cobalt Alloys
E386Practice for Data Presentation Relating to High-
3.1.3 disinfectant—a germicide that is used solely for de-
Resolution Nuclear Magnetic Resonance (NMR) Spec- stroying microorganisms on inanimate objects.
troscopy
3.1.4 disinfection—generally less lethal than sterilization. It
E407Practice for Microetching Metals and Alloys
eliminates virtually all recognized pathogenic microorganisms
E562Test Method for Determining Volume Fraction by
but not necessarily all microbial forms (for example, bacterial
Systematic Manual Point Count
endospores) on inanimate objects. It does not ensure overkill.
E663PracticeforFlameAtomicAbsorptionAnalysis(With-
3.1.5 sterilization—use of a physical or chemical procedure
drawn 1997)
to destroy all microbial life; including large numbers of highly
E860Practice for ExaminingAnd Preparing Items ThatAre
resistant bacterial endospores.
Or May Become Involved In Criminal or Civil Litigation
E883Guide for Reflected–Light Photomicrography 4. Summary of Practice
E986Practice for Scanning Electron Microscope Beam Size
4.1 This practice provides recommendations for collection
Characterization
of clinical data, analysis of adjacent tissues, and the material
E1188Practice for Collection and Preservation of Informa-
characterizations to be performed when an implant is retrieved
tion and Physical Items by a Technical Investigator
as part of a clinical or an animal study. It also provides for
E1479Practice for Describing and Specifying Inductively-
analysis of specimens and lubrication fluids from in vitro wear
Coupled Plasma Atomic Emission Spectrometers
tests.
F316Test Methods for Pore Size Characteristics of Mem-
4.2 The clinical data to be recorded include a case history
brane Filters by Bubble Point and Mean Flow Pore Test
review, roentgenogram reviews, tissue culture, and observa-
F619Practice for Extraction of Medical Plastics
tions of the implant site.
F981Practice for Assessment of Compatibility of Biomate-
4.3 Protocols are provided for the handling of the implant
rials for Surgical Implants with Respect to Effect of
tissue interface, and adjacent tissues and fluids for subsequent
Materials on Muscle and Bone
analysis. These protocols are intended to facilitate (a) histo-
F1044Test Method for Shear Testing of Calcium Phosphate
logicandimmunohistochemicalexaminationofthetissues, (b)
Coatings and Metallic Coatings
chemical analysis of the tissues for identification and quanti-
F1147Test Method for Tension Testing of Calcium Phos-
fication of implant corrosion or degradation products, and (c)
phate and Metallic Coatings
digestion of tissues and fluids for subsequent harvesting and
F1854Test Method for Stereological Evaluation of Porous
analysis of particulate debris.
Coatings on Medical Implants
4.4 The material characterizations include observation and
F1877Practice for Characterization of Particles
description of the retrieved device and adjacent tissues, deter-
F2102Guide for Evaluating the Extent of Oxidation in
mination of chemical composition, macroscopic and micro-
Ultra-High-Molecular-Weight Polyethylene Fabricated
scopic examinations and mechanical property determinations.
Forms Intended for Surgical Implants
The guidelines are separated in three stages. Stage I is
F2182Test Method for Measurement of Radio Frequency
considered to comprise an essential minimum analysis for
Induced Heating On or Near Passive Implants During
routine examination of all types of materials. Stage II is
Magnetic Resonance Imaging
F2214Test Method forIn Situ Determination of Network
Parameters of Crosslinked Ultra High Molecular Weight 4
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Polyethylene (UHMWPE) 4th Floor, New York, NY 10036, http://www.ansi.org.
F561 − 05a (2010)
nondestructive but provides more detail and is
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F561–05a Designation: F561 – 05a (Reapproved 2010)
Standard Practice for
Retrieval and Analysis of Medical Devices, and Associated
Tissues and Fluids
ThisstandardisissuedunderthefixeddesignationF561;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 Thispracticecoversrecommendationsfortheretrieval,handling,andanalysisofimplantedmedicaldevicesandassociated
specimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies. This practice can
also be used for analysis of specimens and lubrication fluids from in vitro wear tests and joint simulators. The aim is to provide
guidance in preventing damage to the associated specimens which could obscure the investigational results, and in gathering data
at the proper time and circumstance to validate the study.
1.2 This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons
between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum
non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard
protocols for the examination and collection of data are provided for specific types of materials in relation to their typical
applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical
techniques are employed, the appropriate handling procedures must be specified.
1.3 Thispracticerecommendationshouldbeappliedinaccordancewithnationalregulationsorlegalrequirementsregardingthe
handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become
involved in litigation, as per Practice E860.
1.4 Asignificant portion of the information associated with a retrieved implant device is often at the device-tissue interface or
in the tissues associated with the implant and related organ systems.Attention should be given to the handling of adjacent tissues,
so as not to interfere with study of the particles in the adjacent tissue, a chemical analysis for the byproducts of degradation of
the implant, or a study of the cellular response to the implant.
1.5
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 may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices
should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the implant or the associated
tissue that may be subject to subsequent analysis. A detailed discussion of precautions to be used in handling of human tissues can
be found in ISO 12891-1. 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.
2. Referenced Documents
2.1 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
C20 TestMethodsforApparentPorosity,WaterAbsorption,ApparentSpecificGravity,andBulkDensityofBurnedRefractory
Brick and Shapes by Boiling Water
C158 Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
C169 Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
C573 Test Methods for Chemical Analysis of Fireclay and High-Alumina Refractories
This practice is under the jurisdiction ofASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.18
F04.15 on Device Retrieval Analysis.Material Test Methods.
Current edition approved Oct.Sept. 1, 2005.2010. Published October 2005.November 2010. Originally approved 1978. Last previous edition approved in 2005 as
F561–05a. DOI: 10.1520/F0561-05AR10.
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,orcontactASTMCustomerServiceatservice@astm.org.For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F561 – 05a (2010)
C623 Test Method for Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Glass and Glass-Ceramics by Resonance
C633 Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings
C674 Test Methods for Flexural Properties of Ceramic Whiteware Materials
C730 Test Method for Knoop Indentation Hardness of Glass
C1069 Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
C1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
C1198 Test Method for Dynamic Young’s Modulus, Shear Modulus, and Poisson’s Ratio for Advanced Ceramics by Sonic
Resonance
C1322 Practice for Fractography and Characterization of Fracture Origins in Advanced Ceramics
C1326 Test Method for Knoop Indentation Hardness of Advanced Ceramics
C1327 Test Method for Vickers Indentation Hardness of Advanced Ceramics
D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D570 Test Method for Water Absorption of Plastics
D621 Test Methods for Deformation of Plastics Under Load
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D638 Test Method for Tensile Properties of Plastics
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D695 Test Method for Compressive Properties of Rigid Plastics
D732 Test Method for Shear Strength of Plastics by Punch Tool
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D785 Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1004 Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
D1042 Test Method for Linear Dimensional Changes of Plastics Under Accelerated Service Conditions
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
D1242 Test Methods for Resistance of Plastic Materials to Abrasion
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1621 Test Method for Compressive Properties of Rigid Cellular Plastics
D1622 Test Method for Apparent Density of Rigid Cellular Plastics
D1623 Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
D1708 Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
D2240 Test Method for Rubber PropertyDurometer Hardness
D2842 Test Method for Water Absorption of Rigid Cellular Plastics
D2857 Practice for Dilute Solution Viscosity of Polymers
D2873 Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry
D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D3016 Practice for Use of Liquid Exclusion Chromatography Terms and Relationships
D3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)
D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential
Scanning Calorimetry
D3835 Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
D3919 Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
D4000 Classification System for Specifying Plastic Materials
D4001 Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering
D4065 Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures
D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
D5152 Practice for Water Extraction of Residual Solids from Degraded Plastics for Toxicity Testing
D5227 Test Method for Measurement of Hexane Extractable Content of Polyolefins
D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance
Size-Exclusion Chromatography
E3 Guide for Preparation of Metallographic Specimens
E7 Terminology Relating to Metallography
E8 Test Methods for Tension Testing of Metallic Materials
E10 Test Method for Brinell Hardness of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
F561 – 05a (2010)
E45 Test Methods for Determining the Inclusion Content of Steel
E92 Test Method for Vickers Hardness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
E120 Test Methods for Chemical Analysis of Titanium and Titanium Alloys
E135 Terminology Relating to Analytical Chemistry for Metals, Ores, and Related Materials
E168 Practices for General Techniques of Infrared Quantitative Analysis
E204 PracticesforIdentificationofMaterialbyInfraredAbsorptionSpectroscopy,UsingtheASTMCodedBandandChemical
Classification Index
E290 Test Methods for Bend Testing of Material for Ductility
E353 Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron
Alloys
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
E386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy
E407 Practice for Microetching Metals and Alloys
E562 Test Method for Determining Volume Fraction by Systematic Manual Point Count
E663 Practice for Flame Atomic Absorption Spectroscopy
E860 Practice for Examining And Preparing Items That Are Or May Become Involved In Criminal or Civil Litigation
E883 Guide for ReflectedLight Photomicrography
E986 Practice for Scanning Electron Microscope Beam Size Characterization
E1188 Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator
E1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
F619 Practice for Extraction of Medical Plastics
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1854 Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F1877 Practice for Characterization of Particles
F2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended
for Surgical Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging
F2214 Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight
Polyethylene (UHMWPE)
F561 – 05a (2010)
2.2 Other Document:
ISO 12891-1, Retrieval and Analysis of Implantable Medical Devices, Part 1: Standard Practice for Retrieval and Handling
3. Terminology
3.1 Definition of Terms Specific to Issues of Microbial Contamination:
3.1.1 antiseptic—a germicide that is used on skin or living tissue for the purposes of inhibiting or destroying microorganisms.
3.1.2 decontamination—a process or treatment that renders a medical device, instrument, or environmental surface safe to
handle. Ranges from sterilization to cleaning with soap and water.
3.1.3 disinfectant—a germicide that is used solely for destroying microorganisms on inanimate objects.
3.1.4 disinfection—generally less lethal than sterilization. It eliminates virtually all recognized pathogenic microorganisms but
not necessarily all microbial forms (for example, bacterial endospores) on inanimate objects. It does not ensure overkill.
3.1.5 sterilization—use of a physical or chemical procedure to destroy all microbial life; including large numbers of highly
resistant bacterial endospores.
4. Summary of Practice
4.1 This practice provides recommendations for collection of clinical data, analysis of adjacent tissues, and the material
characterizationstobeperformedwhenanimplantisretrievedaspartofaclinicalorananimalstudy.Italsoprovidesforanalysis
of specimens and lubrication fluids from in vitro wear tests.
4.2 The clinical data to be recorded include a case history review, roentgenogram reviews, tissue culture, and observations of
the implant site.
4.3 Protocols are provided for the handling of the implant tissue interface, and adjacent tissues and fluids for subsequent
analysis.Theseprotocolsareintendedtofacilitate(a)histologicandimmunohistochemicalexaminationofthetissues,(b)chemical
analysisofthetissuesforidentificationandquantificationofimplantcorrosionordegradationproducts,and (c)digestionoftissues
and fluids for subsequent harvesting and analysis of particulate debris.
4.4 The material characterizations include observation and description of the retrieved device and adjacent tissues,
determination of chemical composition, macroscopic and microscopic examinations and mechanical property determinations.The
guidelines are separated in three stages. Stage I is considered to comprise an essential minimum analysis for routine examination
of all types of materials. Stage II is nondestructive but provides more detail and is intended for special studies of
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