ASTM F2902-2016 Standard Guide for Assessment of Absorbable Polymeric Implants《可吸收聚合物植入物评定指南》.pdf

1、Designation: F2902 16Standard 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, enzymatically in-duced degradation).1.5 This guide references and generally d

8、escribes variousmeans 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 applicatio

9、n.1.6 Adherence to 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,

10、 antimicrobials, and 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 po

11、lymers with ceramicsand/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

12、units of measurement 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

13、regulatory limitations 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

14、 Density) of Plastics by DisplacementD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and Moisture1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on P

15、olymeric Materials.Current edition approved Dec. 1, 2016. Published January 2017. Originallyapproved in 2012. Last previous edition approved in 2012 as F2902 - 12. DOI:10.1520/F2902-16.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceast

16、m.org. For 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 StatesThis international standard was developed in accordance with in

17、ternationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1D2990 Test Methods for Tensile, Compressive,

18、and FlexuralCreep and Creep-Rupture of PlasticsD2991 Test Method for Stress-Relaxation of Plastics (With-drawn 1990)3D3079 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 Crystalliz

19、ation of Polymers byDifferential Scanning CalorimetryD4404 Test Method for Determination of Pore Volume andPore Volume Distribution of Soil and Rock by MercuryIntrusion PorosimetryD5296 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Polystyrene by HighPerformance Size-

20、Exclusion ChromatographyE96/E96M Test Methods for Water Vapor Transmission ofMaterialsE128 Test Method for Maximum Pore 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-sureme

21、ntE467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing SystemE793 Test Method for Enthalpies of Fusion and Crystalliza-tion by Differential Scanning CalorimetryE794 Test Method for MeltingAnd Crystallization Tempera-tures By Thermal AnalysisE1356 Test Meth

22、od for Assignment of the Glass TransitionTemperatures by Differential Scanning CalorimetryE1441 Guide for Computed Tomography (CT) ImagingE1570 Practice for Computed Tomographic (CT) Examina-tionE2207 Practice for Strain-Controlled Axial-Torsional Fa-tigue Testing with Thin-Walled Tubular SpecimensF

23、99 Guide for Writing a Specification for Flexible BarrierRollstock MaterialsF316 Test Methods for Pore Size Characteristics 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 Vapo

24、r Transmission RateThrough Plastic Film and Sheeting Using a ModulatedInfrared SensorF1635 Test Method for in vitro Degradation Testing ofHydrolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF1925 Specification for Semi-Crystalline Poly(lactide) Poly-mer and Copolymer Re

25、sins for Surgical ImplantsF1980 Guide for Accelerated Aging of Sterile Barrier Sys-tems for Medical DevicesF1983 Practice for Assessment of Selected Tissue Effects ofAbsorbable Biomaterials for Implant ApplicationsF2097 Guide for Design and Evaluation of Primary FlexiblePackaging for Medical Product

26、sF2210 Guide for Processing Cells, Tissues, and Organs forUse in Tissue Engineered Medical Products (Withdrawn2015)3F2313 Specification 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 Assessin

27、g Microstructure of PolymericScaffolds for Use in Tissue-Engineered Medical ProductsF2477 Test Methods for in vitro Pulsatile Durability Testingof Vascular StentsF2502 Specification and Test Methods for Absorbable Platesand Screws for Internal Fixation ImplantsF2559 Guide for Writing a Specification

28、 for Sterilizable PeelPouchesF2579 Specification for Amorphous Poly(lactide) andPoly(lactide-co-glycolide) Resins for Surgical ImplantsF2791 Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions2.2 ISO Standards:4ISO 10993 Biological Evaluation of Medical DevicesISO 11

29、135 Sterilization of Health Care ProductsEthyleneOxideISO 11137 Sterilization of Health Care ProductsRadiationISO 13485 Medical DevicesQuality ManagementSystemsRequirements for Regulatory PurposesISO 13781 Poly(L-lactide) Resins and Fabricated Forms forSurgical ImplantsIn Vitro Degradation TestingIS

30、O 15814 Implants for SurgeryCopolymers and BlendsBased on PolylactideIn Vitro Degradation TestingISO/TS 12417 Cardiovascular Implants and ExtracorporealSystemsVascular Device-Drug Combination ProductsISO 9000 Quality Management SystemsFundamentalsand VocabularyISO 9001 Quality Systems Management2.3

31、AAMI Standards:5AAMI STBK91 SterilizationPart 1: Sterilization inHealth Care FacilitiesAAMI STBK92 SterilizationPart 2: Sterilization Equip-mentAAMI STBK93 SterilizationPart 3: Industrial ProcessAAMI TIR17 Compatibility of Materials Subject to Steril-ization2.4 U. S. Code of Federal Regulations:621

32、CFR Part 58 Title 21 FoodAnd DrugAdministration, Part58Good Laboratory Practice for Nonclinical LaboratoryStudies21 CFR Part 820 Title 21 Food And Drug Administration,Part 820Quality System Regulation3The last approved version of this historical standard is referenced onwww.astm.org.4Available from

33、American National Standards Institute (ANSI), 25 W. 43rd St.,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. Governmen

34、t Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:/www.access.gpo.gov.F2902 1622.5 U. S. Pharmacopeia (USP) Standards:7Heavy MetalsMethod IIDrug ReleaseUniformity of Dosage UnitsSterile Product PackagingIntegrity EvaluationSterility Test

35、ingValidation of Isolator 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 Hum

36、an Use, Quality Guideline: 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

37、 1See Appendix X4 for a discussion 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

38、-crobials are typical examples 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

39、 or more added materials 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 sol

40、id and can be either intentionally 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 va

41、rious in-tended uses, processing 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 precli

42、nical tests on absorbable 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 signi

43、ficantly from the base polymer. 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

44、 provisions of the FDA GoodLaboratories 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 exam

45、ple, CE approval;US-FDAInvestigational 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 relev

46、ance of each assessment needs 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 fabric

47、ated through thermal means, 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 inclu

48、des screws, tacks, barbs, 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 temperatur

49、es. Consequently, the impact 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 form. 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