ASTM F561-2013 Standard Practice for Retrieval and Analysis of Medical Devices and Associated Tissues and Fluids《对医疗器械及相关职责和液体进行回收和分析的标准实施规程》.pdf

《ASTM F561-2013 Standard Practice for Retrieval and Analysis of Medical Devices and Associated Tissues and Fluids《对医疗器械及相关职责和液体进行回收和分析的标准实施规程》.pdf》由会员分享，可在线阅读，更多相关《ASTM F561-2013 Standard Practice for Retrieval and Analysis of Medical Devices and Associated Tissues and Fluids《对医疗器械及相关职责和液体进行回收和分析的标准实施规程》.pdf（28页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F561 05a (Reapproved 2010)F561 13Standard 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

2、case of 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

3、medical devices and associatedspecimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies. This practice canalso be used for analysis of specimens and lubrication fluids from in vitro wear tests and joint simulators. The aim is to provideguidance in

4、preventing damage to the associated specimens which could obscure the investigational results, and in gathering dataat 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 comparisonsbe

5、tween investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimumnon-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standardprotocols for the examination and collection of

6、data are provided for specific types of materials in relation to their typicalapplications. For particular investigational programs, additional, more specific, protocols may be required. If special analyticaltechniques are employed, the appropriate handling procedures must be specified.1.3 This prac

7、tice recommendation should be applied in accordance with national regulations or legal requirements regarding thehandling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may becomeinvolved in litigation, as per Practice E860.1.4 A significant

8、portion of the information associated with a retrieved implant device is often at the device-tissue interface orin 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 th

9、e adjacent tissue, a chemical analysis for the byproducts of degradation ofthe implant, or a study of the cellular response to the implant.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 hazar

10、dous materials, operations, and equipment. As a precautionary measure, explanted devicesshould be sterilized or minimally disinfected by an appropriate means that does not adversely affect the implant or the associatedtissue that may be subject to subsequent analysis. A detailed discussion of precau

11、tions to be used in handling of human tissues canbe found in ISO 12891-1. This standard does not purport to address all of the safety concerns, if any, associated with its use. Itis the responsibility of the user of this standard to establish appropriate safety and health practices and determine the

12、 applicabilityof regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless SteelsA751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel ProductsC20 Test Methods for

13、Apparent Porosity, Water Absorption, Apparent Specific Gravity, and Bulk Density of Burned RefractoryBrick and Shapes by Boiling WaterC158 Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)C169 Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass1 T

14、his practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15on Material Test Methods.Current edition approved Sept. 1, 2010Sept. 1, 2013. Published November 2010October 2013. Originally approved 197

15、8. Last previous edition approved in 20052010 asF561 05a.F561 05a (2010). DOI: 10.1520/F0561-05AR10.10.1520/F0561-132 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to t

16、he standards Document Summary page on the ASTM website.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. Becauseit may not be technically possible to adequately depict all changes a

17、ccurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United

18、States1C573 Methods for Chemical Analysis of Fireclay and High-Alumina Refractories (Withdrawn 1995)3C623 Test Method for Youngs Modulus, Shear Modulus, and Poissons Ratio for Glass and Glass-Ceramics by ResonanceC633 Test Method for Adhesion or Cohesion Strength of Thermal Spray CoatingsC674 Test M

19、ethods for Flexural Properties of Ceramic Whiteware MaterialsC730 Test Method for Knoop Indentation Hardness of GlassC1069 Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen AdsorptionC1161 Test Method for Flexural Strength of Advanced Ceramics at Ambient TemperatureC1198 Test Me

20、thod for Dynamic Youngs Modulus, Shear Modulus, and Poissons Ratio for Advanced Ceramics by SonicResonanceC1322 Practice for Fractography and Characterization of Fracture Origins in Advanced CeramicsC1326 Test Method for Knoop Indentation Hardness of Advanced CeramicsC1327 Test Method for Vickers In

21、dentation Hardness of Advanced CeramicsD256 Test Methods for Determining the Izod Pendulum Impact Resistance of PlasticsD412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTensionD570 Test Method for Water Absorption of PlasticsD621 Specification for Jute Rove and Plied Yarn for Elec

22、trical and Packing Purposes (Withdrawn 2000)3D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic ElastomersD638 Test Method for Tensile Properties of PlasticsD671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)3D695 Test

23、 Method for Compressive Properties of Rigid PlasticsD732 Test Method for Shear Strength of Plastics by Punch ToolD747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever BeamD785 Test Method for Rockwell Hardness of Plastics and Electrical Insulating MaterialsD790 Test Meth

24、ods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating MaterialsD792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementD1004 Test Method for Tear Resistance (Graves Tear) of Plastic Film and SheetingD1042 Test Method fo

25、r Linear Dimensional Changes of Plastics Caused by Exposure to Heat and MoistureD1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion PlastometerD1239 Test Method for Resistance of Plastic Films to Extraction by ChemicalsD1242 Test Methods for Resistance of Plastic Materials to Abrasi

26、on (Withdrawn 2003)3D1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1621 Test Method for Compressive Properties of Rigid Cellular PlasticsD1622 Test Method for Apparent Density of Rigid Cellular PlasticsD1623 Test Method for Tensile and Tensile Adhesion Properties of Rigi

27、d Cellular PlasticsD1708 Test Method for Tensile Properties of Plastics by Use of Microtensile SpecimensD2240 Test Method for Rubber PropertyDurometer HardnessD2842 Test Method for Water Absorption of Rigid Cellular PlasticsD2857 Practice for Dilute Solution Viscosity of PolymersD2873 Test Method fo

28、r Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry (Withdrawn2003)3D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of PlasticsD3016 Practice for Use of Liquid Exclusion Chromatography Terms and RelationshipsD3417 Test Method fo

29、r Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)(Withdrawn 2004)3D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by DifferentialScanning CalorimetryD3835 Test Method for Determination of Propertie

30、s of Polymeric Materials by Means of a Capillary RheometerD3919 Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption SpectrophotometryD4000 Classification System for Specifying Plastic MaterialsD4001 Test Method for Determination of Weight-Average Molecular Weight of

31、Polymers By Light ScatteringD4065 Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of ProceduresD4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration CellD5152 Practice for Water Extraction of Residual Solids from Degraded Plastics f

32、or Toxicity Testing (Withdrawn 1998)3D5227 Test Method for Measurement of Hexane Extractable Content of PolyolefinsD5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High PerformanceSize-Exclusion Chromatography3 The last approved version of this hist

33、orical standard is referenced on www.astm.org.F561 132E3 Guide for Preparation of Metallographic SpecimensE7 Terminology Relating to MetallographyE8 Test Methods for Tension Testing of Metallic MaterialsE10 Test Method for Brinell Hardness of Metallic MaterialsE18 Test Methods for Rockwell Hardness

34、of Metallic MaterialsE45 Test Methods for Determining the Inclusion Content of SteelE92 Test Method for Vickers Hardness of Metallic Materials (Withdrawn 2010)3E112 Test Methods for Determining Average Grain SizeE120 Test Methods for Chemical Analysis of Titanium and Titanium Alloys (Withdrawn 2003)

35、3E135 Terminology Relating to Analytical Chemistry for Metals, Ores, and Related MaterialsE168 Practices for General Techniques of Infrared Quantitative AnalysisE204 Practices for Identification of Material by InfraredAbsorption Spectroscopy, Using theASTM Coded Band and ChemicalClassification Index

36、E290 Test Methods for Bend Testing of Material for DuctilityE353 Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-IronAlloysE354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, a

37、ndCobalt AlloysE386 Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) SpectroscopyE407 Practice for Microetching Metals and AlloysE562 Test Method for Determining Volume Fraction by Systematic Manual Point CountE663 Practice for Flame Atomic Absorption Analy

38、sis (Withdrawn 1997)3E860 Practice for Examining And Preparing Items That Are Or May Become Involved In Criminal or Civil LitigationE883 Guide for ReflectedLight PhotomicrographyE986 Practice for Scanning Electron Microscope Beam Size CharacterizationE1188 Practice for Collection and Preservation of

39、 Information and Physical Items by a Technical InvestigatorE1479 Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission SpectrometersF316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore TestF619 Practice for Extraction of M

40、edical PlasticsF981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and BoneF1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsF1147 Test Method for Tension Testing of Calcium Phosphate an

41、d Metallic CoatingsF1854 Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsF1877 Practice for Characterization of ParticlesF2102 Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intendedfor Surgical ImplantsF2182 T

42、est Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During MagneticResonance ImagingF2214 Test Method forIn Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene(UHMWPE)F2995 Guide for Shipping Possibly Infectious Mater

43、ials, Tissues, and FluidsF561 1332.2 Other Document:4ISO 12891-1, Retrieval and Analysis of Implantable Medical Devices, Part 1: Standard Practice for Retrieval and Handling3. Terminology3.1 Definition of Terms Specific to Issues of Microbial Contamination:3.1.1 antiseptica germicide that is used on

44、 skin or living tissue for the purposes of inhibiting or destroying microorganisms.3.1.2 decontaminationa process or treatment that renders a medical device, instrument, or environmental surface safe tohandle. Ranges from sterilization to cleaning with soap and water.3.1.3 disinfectanta germicide th

45、at is used solely for destroying microorganisms on inanimate objects.3.1.4 disinfectiongenerally less lethal than sterilization. It eliminates virtually all recognized pathogenic microorganisms butnot necessarily all microbial forms (for example, bacterial endospores) on inanimate objects. It does n

46、ot ensure overkill.3.1.5 sterilizationuse of a physical or chemical procedure to destroy all microbial life; including large numbers of highlyresistant bacterial endospores.4. Summary of Practice4.1 This practice provides recommendations for collection of clinical data, analysis of adjacent tissues,

47、 and the materialcharacterizations to be performed when an implant is retrieved as part of a clinical or an animal study. It also provides for analysisof specimens and lubrication fluids from in vitro wear tests.4.2 The clinical data to be recorded include a case history review, roentgenogram review

48、s, tissue culture, and observations ofthe implant site.4.3 Protocols are provided for the handling of the implant tissue interface, and adjacent tissues and fluids for subsequentanalysis.These protocols are intended to facilitate (a) histologic and immunohistochemical examination of the tissues, (b)

49、 chemicalanalysis of the tissues for identification and quantification of implant corrosion or degradation products, and (c) digestion of tissuesand 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. Theguidelines are separated in three stages. Stage I is considered to comprise an essential minimum analysis for routi