1、Designation: F561 05a (Reapproved 2010)Standard Practice forRetrieval and Analysis of Medical Devices, and AssociatedTissues and Fluids1This standard is issued under the fixed designation F561; the number immediately following the designation indicates the year of originaladoption or, in the case of
2、 revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers recommendations for the retrieval,handling, and analysis of implanted medical
3、devices andassociated specimens that are removed from patients duringrevision surgery, at postmortem, or as part of animal studies.This practice can also be used for analysis of specimens andlubrication fluids from in vitro wear tests and joint simulators.The aim is to provide guidance in preventing
4、 damage to theassociated specimens which could obscure the investigationalresults, and in gathering data at the proper time and circum-stance to validate the study.1.2 This practice offers guidelines for the analysis of re-trieved implants to limit damage to them, and to allowcomparisons between inv
5、estigational results from differentstudies. The protocols are divided into three stages, whereStage I is the minimum non-destructive analysis, Stage II ismore complete non-destructive analysis, and Stage III isdestructive analysis. Standard protocols for the examinationand collection of data are pro
6、vided for specific types ofmaterials in relation to their typical applications. For particularinvestigational programs, additional, more specific, protocolsmay be required. If special analytical techniques are employed,the appropriate handling procedures must be specified.1.3 This practice recommend
7、ation should be applied inaccordance with national regulations or legal requirementsregarding the handling and analysis of retrieved implants andexcised tissues, especially with regard to handling deviceswhich may become involved in litigation, as per Practice E860.1.4 A significant portion of the i
8、nformation associated witha retrieved implant device is often at the device-tissue interfaceor in the tissues associated with the implant and related organsystems. Attention should be given to the handling of adjacenttissues, so as not to interfere with study of the particles in theadjacent tissue,
9、a chemical analysis for the byproducts ofdegradation of the implant, or a study of the cellular responseto the implant.1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 This standard may involve hazardous materials, opera-
10、tions, and equipment. As a precautionary measure, explanteddevices should be sterilized or minimally disinfected by anappropriate means that does not adversely affect the implant orthe associated tissue that may be subject to subsequentanalysis. A detailed discussion of precautions to be used inhand
11、ling of human tissues can be found in ISO 12891-1. Thisstandard does not purport to address all of the safety concerns,if any, associated with its use. It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulato
12、ry limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA751 Test Methods, Practices, and Terminology for Chemi-cal Analysis of Steel ProductsC20 Test Methods forApparent Porosity, WaterA
13、bsorption,Apparent Specific Gravity, and Bulk Density of BurnedRefractory Brick and Shapes by Boiling WaterC158 Test Methods for Strength of Glass by Flexure (De-termination of Modulus of Rupture)C169 Test Methods for Chemical Analysis of Soda-Limeand Borosilicate GlassC573 Test Methods for Chemical
14、 Analysis of Fireclay andHigh-Alumina Refractories3C623 Test Method for Youngs Modulus, Shear Modulus,and Poissons Ratio for Glass and Glass-Ceramics byResonanceC633 Test Method for Adhesion or Cohesion Strength ofThermal Spray CoatingsC674 Test Methods for Flexural Properties of CeramicWhiteware Ma
15、terials1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Sept. 1, 2010. Published November 2010. Originallyapproved 1978. Last previous ed
16、ition approved in 2005 as F561 05a. DOI:10.1520/F0561-05AR10.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.
17、3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.C730 Test Method for Knoop Indentation Hardness of GlassC1069 Test Method for Specific SurfaceArea ofAlumina orQuartz by Nitrogen AdsorptionC1161 Test Method for Flexural Str
18、ength of AdvancedCeramics at Ambient TemperatureC1198 Test Method for Dynamic Youngs Modulus, ShearModulus, and Poissons Ratio for Advanced Ceramics bySonic ResonanceC1322 Practice for Fractography and Characterization ofFracture Origins in Advanced CeramicsC1326 Test Method for Knoop Indentation Ha
19、rdness ofAdvanced CeramicsC1327 Test Method for Vickers Indentation Hardness ofAdvanced CeramicsD256 Test Methods for Determining the Izod PendulumImpact Resistance of PlasticsD412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD570 Test Method for Water Absorption of Plastic
20、sD621 Test Methods for Deformation of Plastics UnderLoad3D624 Test Method for Tear Strength of Conventional Vul-canized Rubber and Thermoplastic ElastomersD638 Test Method for Tensile Properties of Plastics3D671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force3D695 Test Met
21、hod for Compressive Properties of RigidPlasticsD732 Test Method for Shear Strength of Plastics by PunchToolD747 Test Method for Apparent Bending Modulus of Plas-tics by Means of a Cantilever BeamD785 Test Method for Rockwell Hardness of Plastics andElectrical Insulating MaterialsD790 Test Methods fo
22、r Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsD792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD1004 Test Method for Tear Resistance (Graves Tear) ofPlastic Film and SheetingD1042 Test Method for Linea
23、r Dimensional Changes ofPlastics Under Accelerated Service ConditionsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1239 Test Method for Resistance of Plastic Films toExtraction by Chemicals3D1242 Test Methods for Resistance of Plastic Materials toAbrasion3D1505 Test
24、 Method for Density of Plastics by the Density-Gradient TechniqueD1621 Test Method for Compressive Properties of RigidCellular PlasticsD1622 Test Method for Apparent Density of Rigid CellularPlasticsD1623 Test Method for Tensile and Tensile Adhesion Prop-erties of Rigid Cellular PlasticsD1708 Test M
25、ethod for Tensile Properties of Plastics byUse of Microtensile SpecimensD2240 Test Method for Rubber PropertyDurometerHardnessD2842 Test Method for Water Absorption of Rigid CellularPlasticsD2857 Practice for Dilute Solution Viscosity of Polymers3D2873 Test Method for Interior Porosity of Poly(Vinyl
26、Chloride) (PVC) Resins by Mercury Intrusion Porosim-etry3D2990 Test Methods for Tensile, Compressive, and Flex-ural Creep and Creep-Rupture of PlasticsD3016 Practice for Use of Liquid Exclusion Chromatogra-phy Terms and RelationshipsD3417 Test Method for Enthalpies of Fusion and Crystal-lization of
27、Polymers by Differential Scanning Calorimetry(DSC)3D3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD3835 Test Method for Determination of Properties ofPolymeric Materials by Means of a Capillary RheometerD3919
28、 Practice for Measuring Trace Elements in Water byGraphite Furnace Atomic Absorption SpectrophotometryD4000 Classification System for Specifying Plastic Materi-alsD4001 Test Method for Determination of Weight-AverageMolecular Weight of Polymers By Light ScatteringD4065 Practice for Plastics: Dynamic
29、 Mechanical Proper-ties: Determination and Report of ProceduresD4754 Test Method for Two-Sided Liquid Extraction ofPlastic Materials Using FDA Migration CellD5152 Practice for Water Extraction of Residual Solidsfrom Degraded Plastics for Toxicity Testing3D5227 Test Method for Measurement of Hexane E
30、xtract-able Content of PolyolefinsD5296 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Polystyrene by HighPerformance Size-Exclusion ChromatographyE3 Guide for Preparation of Metallographic SpecimensE7 Terminology Relating to MetallographyE8 Test Methods for Tension Te
31、sting of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness of Metallic Ma-terialsE45 Test Methods for Determining the Inclusion Content ofSteelE92 Test Method for Vickers Hardness of Metallic Materi-als3E112 Test Methods for Determinin
32、g Average Grain SizeE120 Test Methods for Chemical Analysis of Titanium andTitanium Alloys3E135 Terminology Relating to Analytical Chemistry forMetals, Ores, and Related MaterialsE168 Practices for General Techniques of Infrared Quanti-tative AnalysisE204 Practices for Identification of Material by
33、InfraredAbsorption Spectroscopy, Using the ASTM Coded Bandand Chemical Classification IndexF561 05a (2010)2E290 Test Methods for Bend Testing of Material for Duc-tilityE353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron AlloysE354 Tes
34、t Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectros-copyE407 Practice for Microetching Metals and AlloysE562 Test Method fo
35、r Determining Volume Fraction bySystematic Manual Point CountE663 Practice for Flame Atomic Absorption Spectroscopy3E860 Practice for ExaminingAnd Preparing Items ThatAreOr May Become Involved In Criminal or Civil LitigationE883 Guide for ReflectedLight PhotomicrographyE986 Practice for Scanning Ele
36、ctron Microscope Beam SizeCharacterizationE1188 Practice for Collection and Preservation of Informa-tion and Physical Items by a Technical InvestigatorE1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission SpectrometersF316 Test Methods for Pore Size Characteristics
37、of Mem-brane Filters by Bubble Point and Mean Flow Pore TestF619 Practice for Extraction of Medical PlasticsF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1044 Test Method for Shear Testing of Calcium Phospha
38、teCoatings and Metallic CoatingsF1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF1854 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF1877 Practice for Characterization of ParticlesF2102 Guide for Evaluating the Extent of Oxidation inUl
39、tra-High-Molecular-Weight Polyethylene FabricatedForms Intended for Surgical ImplantsF2182 Test Method for Measurement of Radio FrequencyInduced Heating On or Near Passive Implants DuringMagnetic Resonance ImagingF2214 Test Method for In Situ Determination of NetworkParameters of Crosslinked Ultra H
40、igh Molecular WeightPolyethylene (UHMWPE)2.2 Other Document:4ISO 12891-1, Retrieval and Analysis of Implantable Medi-cal Devices, Part 1: Standard Practice for Retrieval andHandling3. Terminology3.1 Definition of Terms Specific to Issues of MicrobialContamination:3.1.1 antiseptica germicide that is
41、used on skin or livingtissue for the purposes of inhibiting or destroying microorgan-isms.3.1.2 decontaminationa process or treatment that rendersa medical device, instrument, or environmental surface safe tohandle. Ranges from sterilization to cleaning with soap andwater.3.1.3 disinfectanta germici
42、de that is used solely for de-stroying microorganisms on inanimate objects.3.1.4 disinfectiongenerally less lethal than sterilization. Iteliminates virtually all recognized pathogenic microorganismsbut not necessarily all microbial forms (for example, bacterialendospores) on inanimate objects. It do
43、es not ensure overkill.3.1.5 sterilizationuse of a physical or chemical procedureto destroy all microbial life; including large numbers of highlyresistant bacterial endospores.4. Summary of Practice4.1 This practice provides recommendations for collectionof clinical data, analysis of adjacent tissue
44、s, and the materialcharacterizations to be performed when an implant is retrievedas part of a clinical or an animal study. It also provides foranalysis of specimens and lubrication fluids from in vitro weartests.4.2 The clinical data to be recorded include a case historyreview, roentgenogram reviews
45、, tissue culture, and observa-tions of the implant site.4.3 Protocols are provided for the handling of the implanttissue interface, and adjacent tissues and fluids for subsequentanalysis. These protocols are intended to facilitate (a) histo-logic and immunohistochemical examination of the tissues, (
46、b)chemical analysis of the tissues for identification and quanti-fication of implant corrosion or degradation products, and (c)digestion of tissues and fluids for subsequent harvesting andanalysis of particulate debris.4.4 The material characterizations include observation anddescription of the retr
47、ieved device and adjacent tissues, deter-mination of chemical composition, macroscopic and micro-scopic examinations and mechanical property determinations.The guidelines are separated in three stages. Stage I is4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor,
48、New York, NY 10036, http:/www.ansi.org.F561 05a (2010)3considered to comprise an essential minimum analysis forroutine examination of all types of materials. Stage II isnondestructive but provides more detail and is intended forspecial studies of devices with or without impaired function,made of all
49、 types of materials. Stage III includes destructivemethods for and material-specific protocols for detailed failure,microstructural, and chemical analysis as well as determinationof physical and mechanical properties.5. Significance and Use5.1 The investigation of retrieved implantable medical de-vices and adjacent tissues can be of value in the assessment ofclinical complications associated with the use of a specificprosthetic device design; can expand the knowledge of clinicalimplant performance and interactions between implants and thebody; provide information on i
