ASTM F2902-2016e1 Standard Guide for Assessment of Absorbable Polymeric Implants《可吸收聚合物植入物的标准评定指南》.pdf

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1、Designation: F2902 161Standard 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 p

2、arentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEEditorial corrections were made throughout in May 2017.1. Scope1.1 This guide describes general guidelines for thechemical, physical, mechanical, biocomp

3、atibility, and preclini-cal assessments of implantable synthetic 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 manufactur

4、er inestablishing the safety and effectiveness of an absorbableimplant 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 necessaril

5、y reflectthe total needs for any particular implant application (forexample, orthopedic, cardiovascular, sutures, and dermalfillers), which may require additional and potentially essentialapplication-specific evaluations.1.3 This guide is intended to cover all forms of absorbablepolymeric components

6、 and devices, including solid (forexample, injection-molded) and porous (for example, 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 d

7、evices formed from synthetic polymersthat degrade in vivo primarily through hydrolysis (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

8、example, enzymatically in-duced degradation).1.5 This guide references and generally describes 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

9、modification to address the properties ofa particular device, construct, or application.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 Absorbab

10、le polymers used as a matrix to control the invivo release of bioactive agents (drugs, 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 compo

11、sition, loading, release kinetics, safety, andefficacy.1.8 Composites of absorbable polymers 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 c

12、omponent(s).1.9 The values stated in SI units are to be regarded asstandard. No other 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 e

13、stablish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.1.11 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDeve

14、lopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D570 Test Method for Water Absorption of Plastics1This guide is under the jurisdiction of ASTM Committee F04 on

15、 Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric 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/F2902-16E01.2For refer

16、enced ASTM standards, 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.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West

17、Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trad

18、e Organization Technical Barriers to Trade (TBT) Committee.1D638 Test Method for Tensile Properties of PlasticsD695 Test Method for Compressive Properties of RigidPlasticsD732 Test Method for Shear Strength of Plastics by PunchToolD792 Test Methods for Density and Specific Gravity (Rela-tive Density

19、) of Plastics by DisplacementD1042 Test Method for Linear Dimensional Changes ofPlastics Caused by Exposure to Heat and MoistureD1922 Test Method for Propagation Tear Resistance ofPlastic Film and Thin Sheeting by Pendulum MethodD2857 Practice for Dilute Solution Viscosity of PolymersD2990 Test Meth

20、ods for Tensile, Compressive, and FlexuralCreep and Creep-Rupture of PlasticsD3079 Test Method for Water Vapor Transmission of Flex-ible Heat-Sealed Packages for Dry ProductsD3164 Test Method for Strength Properties of AdhesivelyBonded Plastic Lap-Shear Sandwich Joints in Shear byTension LoadingD341

21、8 Test Method for Transition Temperatures and En-thalpies of Fusion and Crystallization of Polymers byDifferential Scanning CalorimetryD3420 Test Method for Pendulum Impact Resistance ofPlastic FilmD3846 Test Method for In-Plane Shear Strength of Rein-forced PlasticsD4404 Test Method for Determinati

22、on of Pore Volume andPore Volume Distribution of Soil and Rock by MercuryIntrusion PorosimetryD4603 Test Method for Determining Inherent Viscosity ofPoly(Ethylene Terephthalate) (PET) by Glass CapillaryViscometerD5225 Test Method for Measuring Solution Viscosity ofPolymers with a Differential Viscom

23、eterD5296 Test Method for Molecular Weight Averages andMolecular Weight Distribution of Polystyrene by HighPerformance Size-Exclusion ChromatographyD5748 Test Method for Protrusion Puncture Resistance ofStretch Wrap FilmE96/E96M Test Methods for Water Vapor Transmission ofMaterialsE128 Test Method f

24、or Maximum Pore Diameter and Perme-ability of Rigid Porous Filters for Laboratory UseE328 Test Methods for Stress Relaxation for Materials andStructuresE398 Test Method for Water Vapor Transmission Rate ofSheet Materials Using Dynamic Relative Humidity Mea-surementE467 Practice for Verification of C

25、onstant 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 Method for Assignment of the Glass Transi

26、tionTemperatures 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 SpecimensF99 Guide for Writing a Specification

27、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 Vapor Transmission RateThrough Plastic Fi

28、lm 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 Resins for Surgical ImplantsF1980 Guide

29、 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 ProductsF2210 Guide for Processing Cells, Ti

30、ssues, 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 Assessing Microstructure of PolymericScaffold

31、s 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 for Sterilizable PeelPouchesF2579 Sp

32、ecification 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 178 Plastics Determination of flexural propertiesISO 180 Plastics Determination of Izod i

33、mpact strengthISO 527-1 Plastics Determination of tensile properties Part 1: General principlesISO 527-2 Plastics Determination of tensile properties Part 2: Test conditions for moulding and extrusion plasticsISO 527-3 Plastics Determination of tensile properties Part 3: Test conditions for films an

34、d sheetsISO 604 Plastics Determination of compressive proper-ties3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.F2902 1612ISO 1628-1 Pla

35、stics Determination of the viscosity ofpolymers in dilute solution using capillary viscometers Part 1: General principlesISO 1628-5 Plastics Determination of the viscosity ofpolymers in dilute solution using capillary viscometers Part 5: Thermoplastic polyester (TP) homopolymers andcopolymersISO 180

36、5 Fishing nets Determination of breaking loadand knot breaking load of netting yarnsISO 2062 Textiles Yarns from packages Determinationof single-end breaking force and elongation at break usingconstant rate of extension (CRE) testerISO 6721-2 Plastics Determination of dynamic mechani-cal properties

37、Part 2: Torsion-pendulum methodISO 9000 Quality Management SystemsFundamentalsand VocabularyISO 9001 Quality Systems ManagementISO 10993 Biological Evaluation of Medical DevicesISO 11135 Sterilization of Health Care ProductsEthyleneOxideISO 11137 Sterilization of Health Care ProductsRadiationISO 116

38、07-1 Packaging for terminally sterilized medicaldevices Part 1: Requirements for materials, sterilebarrier systems and packaging systems.ISO 13485 Medical DevicesQuality ManagementSystemsRequirements for Regulatory PurposesISO 13781 Poly(L-lactide) Resins and Fabricated Forms forSurgical ImplantsIn

39、Vitro Degradation TestingISO 13934-1 Textiles Tensile properties of fabrics Part1: Determination of maximum force and elongation atmaximum force using the strip methodISO 14130 Fibre-reinforced plastic composites Determi-nation of apparent interlaminar shear strength by short-beam methodISO 15814 Im

40、plants for SurgeryCopolymers and BlendsBased on PolylactideIn Vitro Degradation TestingISO/TS 12417 Cardiovascular Implants and ExtracorporealSystemsVascular Device-Drug Combination ProductsISO 800009 Quantities and units Part 9: Physicalchemistry and molecular physics2.3 AAMI Standards:5AAMI STBK91

41、 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 CFR Part 58 Title 21 FoodAn

42、d DrugAdministration, Part58Good Laboratory Practice for Nonclinical LaboratoryStudies21 CFR Part 820 Title 21 Food And Drug Administration,Part 820Quality System Regulation2.5 U. S. Pharmacopeia (USP) Standards:7Elemental Impurities LimitsElemental Impurities ProceduresDrug ReleaseUniformity of Dos

43、age UnitsSterile Product PackagingIntegrity EvaluationSterility TestingValidation of Isolator SystemsSterilizationChemical and Physiochemical Indi-cators and IntegratorsSterilization and Sterility Assurance of CompendialArticles2.6 NIST Document:8NIST SP811 Special Publication SP811: Guide for the U

44、seof the International System of Units (SI)2.7 Other Documents:9ICH Q3C International Conference on Harmonisation ofTechnical Requirements for Registration of Pharmaceuti-cals for Human Use, Quality Guideline: Impurities: Re-sidual Solvents3. Terminology3.1 Definitions:3.1.1 absorbable, adjin the bo

45、dy, 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 discussion regarding the usage ofabsorbable and other related terms.3.1.2 bioactive agent, na

46、ny 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 examples of bioactive agents. Devicestructural components or degradation products that evokelim

47、ited 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 that, uponremoval, produce voids that result in generation of a porousstructure.3.1.4.1 Discus

48、sionThe 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 intentionally orunintentionally added.5Available from Association for the Advancement of Medical I

49、nstrumentation(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. Capitol 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.8Available from National Institute of Standards and Technology (NIST), 100Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http:/www.nis