ASTM F2902-2012 Standard Guide for Assessment of Absorbable Polymeric Implants《可吸收聚合植入物评估的标准指南》.pdf

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1、Designation: F2902 12Standard Guide forAssessment of Absorbable Polymeric Implants1This standard is issued under the fixed designation F2902; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in pa

2、rentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide describes general guidelines for thechemical, physical, mechanical, biocompatibility, and preclini-cal assessments of implantable synthe

3、tic polymeric absorbabledevices. This guide also describes evaluation methods that arepotentially useful and should be considered when assessingabsorbable implants or implant components.1.2 The described evaluations may assist a manufacturer inestablishing the safety and effectiveness of an absorbab

4、leimplant device. This listing of assessment methods may also beutilized to assist in establishing substantial equivalence to anexisting commercially marketed device. However, these poly-meric material-oriented guidelines do not necessarily reflectthe total needs for any particular implant applicati

5、on (forexample, orthopedic, cardiovascular), which may require ad-ditional and potentially essential application-specific evalua-tions.1.3 This guide is intended to cover all forms of absorbablepolymeric components and devices, including solid (forexample, injection-molded) and porous (for example,

6、fibrous)forms. This guide is also intended to cover devices fabricatedfrom amorphous and/or semi-crystalline absorbable polymersystems.1.4 This guide has been generated with principal emphasison the evaluation of devices formed from synthetic polymersthat degrade in vivo primarily through hydrolysis

7、 (for example,-hydroxy-polyesters). Evaluation methods suggested hereinmay or may not be applicable to implants formed frommaterials that, upon implantation, are substantially degradedthrough other mechanisms (for example, enzymatic action).1.5 This guide references and generally describes variousme

8、ans to assess absorbable materials, components, and de-vices. The user needs to refer to specific test methods foradditional details. Additionally, some of the recommended testmethods may require modification to address the properties ofa particular device, construct, or application.1.6 Adherence to

9、 all aspects of these guidelines is notmandatory, in that assessments and tests listed within this guideare not necessarily relevant for all absorbable implant systemsand applications.1.7 Absorbable polymers used as a matrix to control the invivo release of bioactive agents (drugs, antimicrobials, a

10、nd soforth) may be evaluated according to many of the methodsdescribed herein. However, additional test methods not cov-ered by this guide will likely be needed to evaluate a bioactiveagents composition, loading, release kinetics, safety, andefficacy.1.8 Composites of absorbable polymers with cerami

11、csand/or metals may be evaluated according to many of themethods described herein. However, additional test methodsnot covered by this guide will likely be needed to evaluate thecomposites other component(s).1.9 The values stated in SI units are to be regarded asstandard. No other units of measureme

12、nt are included in thisstandard.1.10 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitat

13、ions prior to use.2. Referenced Documents2.1 ASTM Standards:2D570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plast

14、ics by DisplacementD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and MoistureD2990 Test Methods for Tensile, Compressive, and FlexuralCreep and Creep-Rupture of Plastics1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materia

15、ls and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Dec. 1, 2012. Published January 2013. DOI: 10.1520/F290212.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. F

16、or Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1D2991 Test Method for Stress-Relaxation of Plastics (With-drawn 1990)3

17、D3079 Test Method for Water Vapor Transmission of Flex-ible Heat-Sealed Packages for Dry ProductsD3418 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD4404 Test Method for Determination of Pore Volume andPore Volum

18、e Distribution of Soil and Rock by MercuryIntrusion PorosimetryD5296 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Polystyrene by HighPerformance Size-Exclusion ChromatographyE96/E96M Test Methods for Water Vapor Transmission ofMaterialsE128 Test Method for Maximum Po

19、re Diameter and Perme-ability of Rigid Porous Filters for Laboratory UseE398 Test Method for Water Vapor Transmission Rate ofSheet Materials Using Dynamic Relative Humidity Mea-surementE467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing SystemE793 Test Me

20、thod for Enthalpies of Fusion and Crystalliza-tion by Differential Scanning CalorimetryE794 Test Method for MeltingAnd Crystallization Tempera-tures By Thermal AnalysisE1356 Test Method for Assignment of the Glass TransitionTemperatures by Differential Scanning CalorimetryE1441 Guide for Computed To

21、mography (CT) ImagingE1570 Practice for Computed Tomographic (CT) Examina-tionE2207 Practice for Strain-Controlled Axial-Torsional Fa-tigue Testing with Thin-Walled Tubular SpecimensF99 Guide for Writing a Specification for Flexible BarrierRollstock MaterialsF316 Test Methods for Pore Size Character

22、istics of Mem-brane Filters by Bubble Point and Mean Flow Pore TestF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1249 Test Method for Water Vapor Transmission RateThrough Plastic Film and Sheeting Using a ModulatedInfrared SensorF1635 Test Method for in vitro D

23、egradation Testing ofHydrolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF1925 Specification for Semi-Crystalline Poly(lactide) Poly-mer and Copolymer Resins for Surgical ImplantsF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical DevicesF1983 Prac

24、tice for Assessment of Compatibility ofAbsorbable/Resorbable Biomaterials for Implant Applica-tionsF2097 Guide for Design and Evaluation of Primary FlexiblePackaging for Medical ProductsF2210 Guide for Processing Cells, Tissues, and Organs forUse in Tissue Engineered Medical ProductsF2313 Specificat

25、ion for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Frac-tions Greater Than or Equal to 70 % GlycolideF2450 Guide for Assessing Microstructure of PolymericScaffolds for Use in Tissue-Engineered Medical ProductsF2477 Test Methods for in vitro Pulsatile Durabi

26、lity Testingof Vascular StentsF2502 Specification and Test Methods for Absorbable Platesand Screws for Internal Fixation ImplantsF2559 Guide for Writing a Specification for Sterilizable PeelPouchesF2579 Specification for Amorphous Poly(lactide) andPoly(lactide-co-glycolide) Resins for Surgical Impla

27、ntsF2791 Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions2.2 ISO Standards:4ISO 10993 Biological Evaluation of Medical DevicesISO 11135 Sterilization of Health Care ProductsEthyleneOxideISO 11137 Sterilization of Health Care ProductsRadiationISO 13485 Medical Devi

28、cesQuality ManagementSystemsRequirements for Regulatory PurposesISO 13781 Poly(L-lactide) Resins and Fabricated Forms forSurgical ImplantsIn Vitro Degradation TestingISO 15814 Implants for SurgeryCopolymers and BlendsBased on PolylactideIn Vitro Degradation TestingISO/TS 12417 Cardiovascular Implant

29、s and ExtracorporealSystemsVascular Device-Drug Combination ProductsISO 9000 Quality Management SystemsFundamentalsand VocabularyISO 9001 Quality Systems Management2.3 AAMI Standards:5AAMI STBK91 SterilizationPart 1: Sterilization inHealth Care FacilitiesAAMI STBK92 SterilizationPart 2: Sterilizatio

30、n Equip-mentAAMI STBK93 SterilizationPart 3: Industrial ProcessAAMI TIR17 Compatibility of Materials Subject to Steril-ization2.4 U. S. Code of Federal Regulations:621 CFR Part 58 Title 21 FoodAnd DrugAdministration, Part58Good Laboratory Practice for Nonclinical LaboratoryStudies21 CFR Part 820 Tit

31、le 21 Food And Drug Administration,Part 820Quality System Regulation2.5 U. S. Pharmacopeia (USP) Standards:7Heavy MetalsMethod IIDrug Release3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St

32、.,4th Floor, New York, NY 10036, http:/www.ansi.org.5Available from Association for the Advancement of Medical Instrumentation(AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http:/www.aami.org.6Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capito

33、l St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.7Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD 20852-1790, http:/www.usp.org.F2902 122Uniformity of Dosage UnitsSterile Product PackagingIntegrity EvaluationSterility TestingValidation of Isolator

34、 SystemsSterilizationChemical and Physiochemical Indi-cators and IntegratorsSterilization and Sterility Assurance of CompendialArticles2.6 Other Documents:8ICH Q3C International Conference on Harmonisation ofTechnical Requirements for Registration of Pharmaceuti-cals for Human Use, Quality Guideline

35、: Impurities: Re-sidual Solvents3. Terminology3.1 Definitions:3.1.1 absorbable, adjin the body, an initially distinctforeign material or substance that either directly or throughintended degradation can pass through or be metabolized orassimilated by cells and/or tissue.NOTE 1See Appendix X4 for a d

36、iscussion regarding the usage ofabsorbable and other related terms.3.1.2 bioactive agent, nany molecular component in, on,or with the interstices of a device that is intended to elicit adesired tissue or cell response.3.1.2.1 DiscussionGrowth factors, antibiotics, and antimi-crobials are typical exa

37、mples of bioactive agents. Devicestructural components or degradation byproducts that evokelimited localized bioactivity are not included.3.1.3 plasticizer, nsubstance incorporated into a materialto increase its workability, flexibility, or distensibility.3.1.4 porogen, none or more added materials

38、that, uponremoval, produce voids that result in generation of a porousstructure.3.1.4.1 DiscussionThe need for inclusion of a porogen isprocess dependent, with many porous structures able to begenerated without the utilization of porogens.Aporogen can bea gas, liquid, or solid and can be either inte

39、ntionally orunintentionally added.4. Significance and Use4.1 This guide is aimed at providing guidance for assess-ments and evaluations to aid in preclinical research anddevelopment of various absorbable components and devices.4.2 This guide includes brief descriptions of various in-tended uses, pro

40、cessing conditions, assessments, and bothqualitative and quantitative analyses for raw materials tofinished product components.4.3 The user is encouraged to utilize appropriate ASTM andother standards to conduct the physical, chemical, mechanical,biocompatibility, and preclinical tests on absorbable

41、 materials,device components, or devices prior to assessment in an in vivomodel.4.4 Whenever an absorbable material is mixed or coatedwith other substances (bioactive, polymeric, or otherwise), thephysical and degradation properties of the resulting compositemay differ significantly from the base po

42、lymer. Thus, unlessprior experience can justify otherwise, performance character-izations described herein should be conducted on the compos-ite construct rather than on individual components.4.5 Assessments of absorbable materials should be per-formed in accordance with the provisions of the FDA Go

43、odLaboratories Practices Regulations 21 CFR 58, where feasible.4.6 Studies to support regulatory approval for clinical orcommercial use, or both, should conform to appropriatenationally adopted directives or guidelines, or both, for thedevelopment of medical devices for example, CE approval;US-FDAIn

44、vestigational Device Exemption (IDE), Pre- MarketApproval (PMA), or 510K submission.4.7 Assessments based upon data from physical, chemical,mechanical, biocompatibility, and preclinical testing modelsare highly valuable but carry inherent limitations. Thus, theclinical relevance of each assessment n

45、eeds to be carefullyconsidered and the user is cautioned that pre-clinical evalua-tions may not be predictive of human clinical performance.5. Fabrication and Processing Related Features andConsiderations5.1 Thermal ProcessingSynthetic absorbable implants areroutinely fabricated through thermal mean

46、s, with typical ex-amples including extrusion and injection molding. Extrusion istypically used to manufacture fibrous forms (for example,woven or knitted meshes, monofilament or braided sutures,fibrous nonwovens), as well as films and tubes. Injectionmolding typically includes screws, tacks, barbs,

47、 pins, and boneanchors.5.1.1 Thermal Degradation ControlThe act of thermalprocessing can potentially degrade absorbable polymers. Inaddition, any presence of moisture will introduce an additionaldegradation mechanism, which will occur rapidly at elevatedprocessing temperatures. Consequently, the imp

48、act of actualprocessing conditionsincluding temperature, moisture, andtheir variationson the resulting product should be bothunderstood and appropriately controlled.5.2 Solvent CastingSynthetic absorbable implants can befabricated through dissolution in a solvent followed by castinginto a desired fo

49、rm. This process is typically utilized in theformation of films, but other forms are possible.5.2.1 Compositional PurityThe purity of the solvent(s)utilized in the casting process must be known and of a gradesuitable for the intended application. The overall system (thatis, incoming raw materials and all device fabrication processes)needs to maintain a level of particle control appropriate for theintended application. It is important to note that the act ofsolvating a hydrolysable polymer inherently increases its chainmotion, thereby increas