ASTM F561-2005a Standard Practice for Retrieval and Analysis of Medical Devices and Associated Tissues and Fluids《医疗器件和相关组织及液体的修复和分析的标准实施规程》.pdf

1、Designation: F 561 05aStandard Practice forRetrieval and Analysis of Medical Devices, and AssociatedTissues and Fluids1This standard is issued under the fixed designation F 561; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 devices and

3、associated 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 damage to

4、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 investigationa

5、l 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 provided for s

6、pecific 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 recommendation shoul

7、d 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 PracticeE 860.1.4 A significant portion of the information

8、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, a chemical

9、analysis for the byproducts ofdegradation of the implant, or a study of the cellular responseto the implant.1.5 This standard may involve hazardous materials, opera-tions, and equipment. As a precautionary measure, explanteddevices should be sterilized or minimally disinfected by anappropriate means

10、 that does not adversely affect the implant orthe associated tissue that may be subject to subsequentanalysis. A detailed discussion of precautions to be used inhandling of human tissues can be found in ISO 12891-1. Thisstandard does not purport to address all of the safety concerns,if any, associat

11、ed with its use. It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2. Referenced Documents2.1 ASTM Standards:2A 262 Practices for Detecting Susceptibility to Intergranu-lar

12、Attack in Austenitic Stainless SteelsA 751 Test Methods, Practices, and Terminology forChemical Analysis of Steel ProductsC20 Test Methods for Apparent Porosity, Water Absorp-tion, Apparent Specific Gravity and Bulk Density ofBurned Refractory Brick and Shapes by Boiling WaterC 158 Test Methods for

13、Strength of Glass Flexure (Deter-mination of Modulus of Rupture)C 169 Test Methods for Chemical Analysis of Soda-Limeand Borosilicate GlassC 573 Test Methods for Chemical Analysis of Fireclay andHigh-Alumina Refractories3C 623 Test Method for Youngs Modulus, Shear Modulus,and Poissons Ratio for Glas

14、s and Glass-Ceramics byResonanceC 633 Test Method for Adhesion or Cohesion Strength ofThermal Sprayed CoatingsC 674 Test Methods for Flexural Properties of CeramicWhiteware MaterialsC 730 Test Method for Knoop Indentation Hardness ofGlass1This practice is under the jurisdiction ofASTM Committee F04

15、on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.18 on Device Retrieval Analysis.Current edition approved Oct. 1, 2005. Published October 2005. Originallyapproved 1978. Last previous edition approved in 2005 as F 561 05.2For referenced ASTM standards,

16、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.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohock

17、en, PA 19428-2959, United States.C 1069 Test Method for Specific Surface Area of Aluminaor Quartz by Nitrogen AdsorptionC 1161 Test Method for Flexural StrengthAdvanced Ce-ramics at Ambient TemperaturesC 1198 Test Method for Dynamic Youngs Modulus, ShearModulus, and Poissons Ratio for Advanced Ceram

18、ics bySonic ResonanceC 1322 Practice for Fractography and Characterization ofFracture Origins in Advanced CeramicsC 1326 Test Method for Knoop Indentation Hardness ofAdvanced CeramicsC 1327 Test Method for Vickers Indentation Hardness ofAdvanced CeramicsD 256 Test Methods for Determining the Izod Pe

19、ndulumImpact Resistance of PlasticsD 412 Test Methods for Vulcanized Rubber and Thermo-plastic Elastomers-TensionD 570 Test Method for Water Absorption of PlasticsD 621 Test Methods for Deformation of Plastics UnderLoad3D 624 Test Method for Tear Strength of ConventionalVulcanized Rubber and Thermop

20、lastic ElastomersD 638 Test Method for Tensile Properties of PlasticsD 671 Test Method for Flexural Fatigue of Plastics byConstant Amplitude of Force3D 695 Test Method for Compressive Properties of RigidPlasticsD 732 Test Method for Shear Strength of Plastics by PunchToolD 747 Test Method for Appare

21、nt Bending Modulus ofPlastics by Means of a Cantilever BeamD 785 Test Method for Rockwell Hardness of Plastics andElectrical Insulating MaterialsD 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsD 792 Test Methods for Density and Spe

22、cific Gravity (Rela-tive Density) of Plastics by DisplacementD 1004 Test Method for Initial Tear Resistance of PlasticFilm and SheetingD 1042 Test Method for Linear Dimensional Changes ofPlastics Under Accelerated Service ConditionsD 1238 Test Method for Flow Rates of Thermoplastics byExtrusion Plas

23、tometerD 1239 Test Method for Resistance of Plastic Films toExtraction by ChemicalsD 1242 Test Methods for Resistance of Plastic Materials toAbrasion3D 1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD 1621 Test Method for Compressive Properties of RigidCellular PlasticsD 1

24、622 Test Method forApparent Density of Rigid CellularPlasticsD 1623 Test Method for Tensile and Tensile AdhesionProperties of Rigid Cellular PlasticsD 1708 Test Method for Tensile Properties of Plastics byUse of Microtensile SpecimensD 2240 Test Method for Rubber PropertyDurometerHardnessD 2842 Test

25、 Method for WaterAbsorbtion of Rigid CellularPlasticsD 2857 Test Method for Dilute Solution Viscosity of Poly-mersD 2873 Test Method for Interior Porosity of Poly(VinylChloride) (PVC) Resins by Mercury Intrusion Porosim-etry3D 2990 Test Methods for Tensile, Compressive, and Flex-ural Creep and Creep

26、-Rupture of PlasticsD 3016 Practice for Use of Liquid Exclusion Chromatogra-phy Terms and RelationshipsD 3417 Test Methods for Enthalpies of Fusion and Crystal-lization of Polymers by Differential Scanning Calorimetry(DSC)D 3418 Test Method for Transition Temperatures of Poly-mers by Differential Sc

27、anning CalorimetryD 3835 Test Method for Determination of Properties ofPolymeric Materials by Means of a Capillary RheometerD 3919 Practice for Measuring Trace Elements in Water byGraphite Furnace Atomic Absorption SpectrophotometryD 4000 Classification System for Specifying Plastic Mate-rialsD 4001

28、 Test Method for Determination of Weight-AverageMolecular Weight by Light ScatteringD 4065 Practice for Plastics: Dynamic Mechanical Proper-ties: Determination and Report of ProceduresD 4754 Test Method for Two-Sided Liquid Extraction ofPlastic Materials Using FDA Migration CellD 5152 Practice for W

29、ater Extraction of Residual Solidsfrom Degraded Plastics for Toxicity Testing3D 5227 Test Method for Measurement of Hexane Extract-able Content of PolyolefinsD 5296 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Polystyrene by HighPerformance Size-Exclusion Chromatogra

30、phyE3 Practice for Preparation of Metallographic SpecimensE7 Terminology Relating to MetallographyE 8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic Materi-alsE18 Test Methods for Rockwell Hardness and RockwellSuperficial Hardness of Metallic M

31、aterialsE45 Test Methods for Determining the Inclusion Contentof SteelE92 Test Method for Vickers Hardness of Metallic Mate-rialsE112 Test Methods for Determining the Average GrainSizeE 120 Test Methods for ChemicalAnalysis of Titanium andTitanium AlloysE 135 Terminology Relating to Analytical Chemi

32、stry forMetals, Ores, and Related MaterialsE 168 Practices for General Techniques of Infrared Quanti-tative AnalysisF 561 05a2E 204 Practices for Identification of Materials by InfraredAbsorption Spectroscopy Using the ASTM Coded Bandand Chemical Classification IndexE 290 Test Method for Bend Testin

33、g of Material for Duc-tilityE 353 Test Methods for Chemical Analysis of Stainless,Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron AlloysE 354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron,Nickel, and Cobalt AlloysE 386 Practice

34、for Data Presentation Relating to HighResolution Nuclear Magnetic Resonance (NMR) Spectros-copyE 407 Practice for Microetching Metals and AlloysE 562 Practice for Determining Volume Fraction by Sys-tematic Manual Point CountE 663 Practice for FlameAtomicAbsorption Spectroscopy3E 860 Practice for Exa

35、mining and Testing Items that are orMay Become Involved in Products Liability LitigationE 883 Guide for Reflected-Light PhotomicrographyE 986 Practice for Scanning Electron Microscope BeamSize CharacterizationE 1188 Practice for Collection and Preservation of Informa-tion and Physical Items by a Tec

36、hnical InvestigatorE 1479 Practice for Describing and Specifying Inductively-Coupled Plasma Optical Emission SpectrophotometersF 316 Test Method for Pore Size Characteristics of Mem-brane Filters by Bubble Point and Mean Flow Pore TestF 619 Practice for Extraction of Medical PlasticsF 981 Practice f

37、or Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 1044 Test Method for Shear Testing of Calcium Phos-phate Coatings and Metallic CoatingsF 1147 Test Method for Tension Testing of Calcium Phos-phate and Metallic CoatingsF 1854

38、 Test Method for Stereological Evaluation of PorousCoatings on Medical ImplantsF 1877 Practice of Characterization of ParticlesF 2102 Guide for Evaluating the Extent of Oxidation inUltra-High-Molecular-Weight Polyethylene FabricatedForms Intended for Surgical ImplantsF 2182 Test Method for Measureme

39、nt of Radio FrequencyInduced Heating Near Passive Implants During MagneticResonance ImagingF 2214 Test Method for in situ Determination of NetworkParameters of Crosslinked Ultra High Molecular WeightPolyethylene (UHMWPE)2.2 Other Document:4ISO 12891-1, Retrieval and Analysis of Implantable Medi-cal

40、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 used on skin or livingtissue for the purposes of inhibiting or destroying microorgan-isms.3.1.2 decontaminationa process

41、or treatment that rendersa medical device, instrument, or environmental surface safe tohandle. Ranges from sterilization to cleaning with soap andwater.3.1.3 disinfectanta germicide that is used solely for de-stroying microorganisms on inanimate objects.3.1.4 disinfectiongenerally less lethal than s

42、terilization. Iteliminates virtually all recognized pathogenic microorganismsbut not necessarily all microbial forms (for example, bacterialendospores) on inanimate objects. It does not ensure overkill.3.1.5 sterilizationuse of a physical or chemical procedureto destroy all microbial life; including

43、 large numbers of highlyresistant bacterial endospores.4. Summary of Practice4.1 This practice provides recommendations for collectionof clinical data, analysis of adjacent tissues, and the materialcharacterizations to be performed when an implant is retrievedas part of a clinical or an animal study

44、. 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, tissue culture, and observa-tions of the implant site.4.3 Protocols are provided for the handling of the implanttissue

45、interface, and adjacent tissues and fluids for subsequentanalysis. These protocols are intended to facilitate (a) histo-logic and immunohistochemical examination of the tissues, (b)chemical analysis of the tissues for identification and quanti-fication of implant corrosion or degradation products, a

46、nd (c)digestion of tissues and fluids for subsequent harvesting andanalysis of particulate debris.4.4 The material characterizations include observation anddescription of the retrieved device and adjacent tissues, deter-mination of chemical composition, macroscopic and micro-scopic examinations and

47、mechanical property determinations.The guidelines are separated in three stages. Stage I isconsidered to comprise an essential minimum analysis forroutine examination of all types of materials. Stage II isnondestructive but provides more detail and is intended for4Available from American National St

48、andards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.F 561 05a3special studies of devices with or without impaired function,made of all types of materials. Stage III includes destructivemethods for and material-specific protocols for detailed failure,microstructural, and chemical a

49、nalysis 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 implant performance and safety;and thus further the development of biocompatible implantmaterials and devices with improved performance. Compari-son of