ASTM F2150-2013 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products《用于组织功能医学产品的生物材料骨骼测试和描述的标准指南》.pdf

1、Designation: F2150 07F2150 13Standard Guide forCharacterization and Testing of Biomaterial Scaffolds Usedin Tissue-Engineered Medical Products1This standard is issued under the fixed designation F2150; the number immediately following the designation indicates the year oforiginal adoption or, in the

2、 case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide is a resource of currently available test methods for the characterization o

3、f the compositional and structuralaspects of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).1.2 The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface propertiesof a scaffold construct. Such p

4、roperties may be important for the success of a TEMP, especially if they affect cell retention, activityand organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.1.3 This guide may be used in the selection of appropriate test methods for the

5、 generation of an original equipment manufacture(OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.1.4 This guide is intended to be utilized in conjunction with appropriate characterization(s) and evaluation(s) of any raw orstarting

6、material(s) utilized in the fabrication of the scaffold, such as described in Guide F2027.1.5 This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biologicalactivity. This guide does not address the characterization or release profiles of any

7、 biomolecules, cells, drugs, or bioactive agentsthat are used in combination with the scaffold. A determination of the suitability of a particular starting material and/or finishedscaffold structure to a specific cell type and/or tissue engineering application is essential, but will require addition

8、al in vitro and/orin vivo evaluations considered to be outside the scope of this guide.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices

9、and determine the applicability of regulatoryrequirements prior to use.2. Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTensionD570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test M

10、ethod for Deflection Temperature of Plastics Under Flexural Load in the Edgewise PositionD671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)3D695 Test Method for Compressive Properties of Rigid PlasticsD747 Test Method for Apparent Bending Modulus of Pla

11、stics by Means of a Cantilever BeamD790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating MaterialsD792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementD882 Test Method for Tensile Properties of Thin Pla

12、stic SheetingD1042 Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and MoistureD1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion PlastometerD1388 Test Method for Stiffness of Fabrics1 This guide is under the jurisdiction of ASTM Committee F04 on M

13、edical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42on Biomaterials and Biomolecules for TEMPs.Current edition approved Dec. 1, 2007Oct. 1, 2013. Published January 2008December 2013. Originally approved in 2002. Last previous edition approved in 20022007a

14、s F2150 02F2150 07.1. DOI: 10.1520/F2150-07.10.1520/F2150-13.2 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 the standards Document Summary page on the ASTM website.

15、3 The last approved version of this historical standard is referenced on www.astm.org.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

16、adequately depict all changes accurately, 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 Consh

17、ohocken, PA 19428-2959. United States1D1621 Test Method for Compressive Properties of Rigid Cellular PlasticsD1623 Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular PlasticsD1708 Test Method for Tensile Properties of Plastics by Use of Microtensile SpecimensD2857 Practice for

18、 Dilute Solution Viscosity of PolymersD2873 Test Method for 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

19、Chromatography Terms and RelationshipsD3039/D3039M Test Method for Tensile Properties of Polymer Matrix Composite MaterialsD3417 Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC)(Withdrawn 2004)3D3418 Test Method for Transition Temperatur

20、es and Enthalpies of Fusion and Crystallization of Polymers by DifferentialScanning CalorimetryD4001 Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light ScatteringD4404 Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mer

21、cury IntrusionPorosimetryD4603 Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary ViscometerD5226 Practice for Dissolving Polymer MaterialsD5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Per

22、formanceSize-Exclusion ChromatographyD5732 Test Method for Stiffness of Nonwoven Fabrics Using the Cantilever Test (Withdrawn 2008)3D6125 Test Method for Bending Resistance of Paper and Paperboard (Gurley Type Tester) (Withdrawn 2010)3D6420 Test Method for Determination of Gaseous Organic Compounds

23、by Direct Interface Gas Chromatography-MassSpectrometryD6474 Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by HighTemperature Gel Permeation ChromatographyD6539 Test Method for Measurement of the Permeability of Unsaturated Porous Materials by

24、 Flowing AirD6579 Practice for Molecular Weight Averages and Molecular Weight Distribution of Hydrocarbon, Rosin and Terpene Resinsby Size-Exclusion ChromatographyE128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory UseE177 Practice for Use of the Terms

25、Precision and Bias in ASTM Test MethodsE456 Terminology Relating to Quality and StatisticsE473 Terminology Relating to Thermal Analysis and RheologyE691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test MethodE793 Test Method for Enthalpies of Fusion and Crystalli

26、zation by Differential Scanning CalorimetryE794 Test Method for Melting And Crystallization Temperatures By Thermal AnalysisE967 Test Method for Temperature Calibration of Differential Scanning Calorimeters and Differential Thermal AnalyzersE968 Practice for Heat Flow Calibration of Differential Sca

27、nning CalorimetersE996 Practice for Reporting Data in Auger Electron Spectroscopy and X-ray Photoelectron SpectroscopyE1078 Guide for Specimen Preparation and Mounting in Surface AnalysisE1142 Terminology Relating to Thermophysical PropertiesE1294 Test Method for Pore Size Characteristics of Membran

28、e Filters UsingAutomated Liquid Porosimeter (Withdrawn 2008)3E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug ProductsE1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning CalorimetryE1642 Practice for General Technique

29、s of Gas Chromatography Infrared (GC/IR) AnalysisE1829 Guide for Handling Specimens Prior to Surface AnalysisE1994 Practice for Use of Process Oriented AOQL and LTPD Sampling PlansF151 Test Method for Residual Solvents in Flexible Barrier Materials (Withdrawn 2004)3F316 Test Methods for Pore Size Ch

30、aracteristics of Membrane Filters by Bubble Point and Mean Flow Pore TestF748 Practice for Selecting Generic Biological Test Methods for Materials and DevicesF1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared SensorF1251 Terminology Relat

31、ing to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)3F1634 Practice forIn-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant DevicesF1635 Test Method forin vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated F

32、orms forSurgical ImplantsF1884 Test Methods for Determining Residual Solvents in Packaging MaterialsF1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesF1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationsF2150 132F2

33、025 Practice for Gravimetric Measurement of Polymeric Components for Wear AssessmentF2027 Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical ProductsF2212 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Su

34、bstrates for TissueEngineered Medical Products (TEMPs)F2312 Terminology Relating to Tissue Engineered Medical ProductsF2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical ProductsF2603 Guide for Interpreting Images of Polymeric Tissue ScaffoldsF2791 Gu

35、ide for Assessment of Surface Texture of Non-Porous Biomaterials in Two DimensionsF2809 Terminology Relating to Medical and Surgical Materials and DevicesF2883 Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products(TEMPs) and as Device for Surgi

36、cal Implant ApplicationsF2900 Guide for Characterization of Hydrogels used in Regenerative MedicineF2902 Guide for Assessment of Absorbable Polymeric ImplantsG120 Practice for Determination of Soluble Residual Contamination by Soxhlet Extraction2.2 AAMI Standards:4AAMI STBK9-1STBK-1 SterilizationPar

37、t 1: Sterilization in Health Care FacilitiesAAMI STBK9-2STBK-2 SterilizationPart 2: Sterilization EquipmentAAMI STBK9-3STBK-3 SterilizationPart 3: Industrial Process Control2.3 ANSI Standards:5ANSI/ISO/ASQ Q9000-2000:Q9000: Quality Management SystemsFundamentals and VocabularyANSI/ISO/ASQ Q9001-2000

38、:Q9001: Quality Management Systems: Requirements2.4 British Standards Institute:5EN 12441BSI BS EN 124411 British StandardAnimal Tissues and Their Derivatives Utilized in the Manufacture ofMedical DevicesPart 1: Analysis and Management of RiskBSI BS EN 124422 British StandardAnimal Tissues and Their

39、 Derivatives Utilized in the Manufacture of MedicalDevicesPart 2: Controls on Sourcing, Collection, and HandlingBSI BS EN 124423 British StandardAnimal Tissues and Their Derivatives Utilized in the Manufacture of MedicalDevicesPart 3: Validation of the Elimination and/or Inactivation of Viruses and

40、Transmissible Agents2.5 ISO Standards:5ISO 31-8 Physical Chemistry and Molecular PhysicsPart 8: Quantities and UnitsISO 113311331 Determination of the Melt-Mass Flow Rate (MFR) and the Melt Volume-Flow Rate (MVR) of ThermoplasticsISO 10993-9 Biological Evaluation of Medical DevicesPart 9: Degradatio

41、n of Materials Related to Biological TestingISO 10993-13 Biological Evaluation of Medical DevicesPart 13: Identification and Quantification of Degradation Productsfrom PolymersISO 10993-14 Biological Evaluation of Medical DevicesPart 14: Identification and Quantification of Degradation Productsfrom

42、CeramicsISO 10993-15 Biological Evaluation of Medical DevicesPart 15: Identification and Quantification of Degradation Productsfrom Coated and Uncoated Metals and AlloysISO 11357-1 PlasticsDifferential Scanning Calorimetry (DSC)Part 1: General PrinciplesISO 11357-2 PlasticsDifferential Scanning Calo

43、rimetry (DSC)Part 2: Determination of Glass Transition Temperature andGlass Transition Step HeightISO 800009 Quantities and UnitsPart 9: Physical Chemistry and Molecular Physics2.6 U.S. Code of Federal Regulations:621 CFR Part 58 Title 21Food And Drug Administration, Part 58Good Laboratory Practice

44、For Nonclinical LaboratoryStudies21 CFR Part 820 Title 21Food and Drugs Services, Part 820Quality System Regulation2.7 U.S. Pharmacopeia (USP) Standards:7Antimicrobial Effectiveness TestingSterility TestsBiological Reactivity Tests, in vitroBiological Reactivity Tests, in vivoPyrogen Test4 Available

45、 from the Association for the Advancement of Medical Instrumentation, 1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795.5 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.6 Available from U.S. Government Printing Offi

46、ce Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.7 Available from U.S. Pharmacopeia, 12601 Twinbrook Pkwy., Rockville, MD 20852, or through http:/www.usp.org/products/USPNF/. The standards will be are listedby appropriate USP cita

47、tion number. Succeeding USP editions alternately may be referenced.F2150 133Spectrophotometric Identification TestHeavy MetalsElemental ImpuritiesLimitsElemental ImpuritiesProceduresElastomeric Closures for InjectionsBulk Density and Tapped DensitySource: General Tests and AssaysUSP30/NF25, May 1, 2

48、007 ContainersPlasticsDensity of SolidsDisintegrationLoss on DryingMass SpectrometryMelting Range or TemperatureNuclear Magnetic ResonanceOptical MicroscopyParticle Size Distribution Estimation by Analytical SievingSpecific Surface AreaSpectrophotometry and Light-ScatteringTensile StrengthThermal An

49、alysisViscosityWater DeterminationX-Ray DiffractionBiotechnology Derived ArticlesScanning Electron MicroscopySterilization and Sterility Assurance of Compendial ArticlesValidation of Compendial Procedures2.8 NIST Document:8NIST SP811 Special Publication SP811: Guide for the Use of the International System of Units (SI)2.9 Other Documents/Web Sites:U.S. Food Final.5.4.3 FDA-CDRH Premarket Approval (PMA) Database:5.4.3.1 http:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm5.4.4 FDA-CDRH 510(k) (Premarket Notification) Database:5.