1、Designation: F3225 17Standard Guide forCharacterization and Assessment of Vascular Graft TissueEngineered Medical Products (TEMPs)1This standard is issued under the fixed designation F3225; the number immediately following the designation indicates the year oforiginal adoption or, in the case of rev
2、ision, 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 intended as a resource for individuals andorganizations involved in the development,
3、production,delivery, and regulation of tissue engineered medical products(TEMPs) intended for use in the surgical repair, replacement,shunting and/or bypass of blood vessels. This guide is intendedfor use related to the in vitro assessment of TEMP vasculargrafts. In vitro cellular characterization a
4、nd in vivo testing arenot within scope for this standard guide.1.2 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, health, and environmental practices and dete
5、r-mine the applicability of regulatory limitations prior to use.1.3 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendat
6、ions issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F1635 Test Method for in vitro Degradation Testing ofHydrolytically Degradable Polymer Resins and FabricatedForms for Surgical ImplantsF2150 Guide for Characterization an
7、d Testing of Biomate-rial Scaffolds Used in Tissue-Engineered Medical Prod-uctsF2210 Guide for Processing Cells, Tissues, and Organs forUse in Tissue Engineered Medical Products (Withdrawn2015)3F2211 Classification for Tissue Engineered Medical Prod-ucts (TEMPs)F2212 Guide for Characterization of Ty
8、pe I Collagen asStarting Material for Surgical Implants and Substrates forTissue Engineered Medical Products (TEMPs)F2312 Terminology Relating to Tissue Engineered MedicalProductsF2382 Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Throm-boplastin Time
9、 (PTT)F2739 Guide for Quantifying Cell Viability within Bioma-terial ScaffoldsSTP 997-EB Compositional Analysis by Thermogravimetry2.2 US FDA Regulations and Guidance Documents:421 CFR 610.12 General Biological Products StandardsSterility21 CFR 1270 Human Tissue Intended for Transplantation21 CFR 12
10、71 Human Cells, Tissues, and Cellular andTissue-Based ProductsFDA Guidance for Industry: Pyrogen and Endotoxins Test-ing: Questions and AnswersGuidance for Industry: Eligibility Determination for Donorsof Human Cells, Tissues, and Cellular and Tissue-BasedProducts (HCT/Ps)FDA Guidance for Industry:
11、Container and Closure SystemIntegrity Testing in Lieu of Sterility Testing as a Compo-nent of the Stability Protocol for Sterile ProductsGuidance for Industry and Food and Drug AdministrationStaff: Use of International Standard ISO-10993-1, Bio-logical Evaluation of Medical DevicesPart 1: Evalua-tio
12、n and testing within a risk management process2.3 ISO Standards:5ISO 7198 Cardiovascular implants and extracorporealsystemsVascular prosthesesTubular vascular graftsand vascular patchesISO 10993 Biological evaluation of medical devices1This guide is under the jurisdiction of ASTM Committee F04 on Me
13、dical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.44 on Assessment for TEMPs.Current edition approved Nov. 15, 2017. Published December 2017. DOI:10.1520/F322517.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Se
14、rvice at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from U.S. Government Printing Office, Superintendent ofDocumen
15、ts, 732 N. Capitol St., NW, Washington, DC 20401-0001, http:/www.access.gpo.gov.5Available from International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.Copyright ASTM International, 100
16、 Barr Harbor Drive, PO Box C700, West 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 Re
17、commendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1ISO 11135 Sterilization of health-care productsEthyleneoxideRequirements for the development, validation androutine control of a sterilization process for medicaldevicesISO 11137 (Parts 1, 2 and 3) Ster
18、ilization of health careproducts RadiationISO 11737-1 Sterilization of medical devicesMicrobiological methodsPart 1: Determination of apopulation of microorganisms on productsISO 11737-2 Sterilization of medical devicesMicrobiological methodsPart 2: Tests of sterility per-formed in the definition, v
19、alidation and maintenance of asterilization processISO 22442-1 Medical devices utilizing animal tissues andtheir derivativesPart 1:Application of risk managementISO 22442-3 Medical devices utilizing animal tissues andtheir derivativesPart 3: Validation of the eliminationand/or inactivation of viruse
20、s and transmissible spongi-form encephalopathy (TSE) agents2.4 Other Documents:United States Pharmacopeia XXVII Sterility TestsICH Harmonized Tripartite Guideline Viral Safety Evalua-tion of Biotechnology Products Derived from Cell Linesof Human or Animal Origin, Q5A(R1)AmericanAssociation of Tissue
21、 Banks (AATB) AATB Stan-dards for Tissue BankingANSI/AAMI ST72 Bacterial EndotoxinsTest Methods,Routine Monitoring, and Alternative to Batch Testing3. Summary of Guide3.1 It is the intent of this guide to provide a compendium ofinformation that may be related to the functional characteristicsof vasc
22、ular graft TEMPs intended to surgically replace, bypassor form shunts between sections of the vascular system.Examples of functional characteristics include vasoactivity andmechanical properties (e.g., burst pressure, tensile strength,creep) suitable for implantation. TEMPs may be composed ofbiologi
23、cal products (e.g., cells, organs, tissues, and processedbiologics), biomaterials (e.g., substrates and scaffolds com-posed of polymers or extracellular matrix (ECM) componentssuch as collagen), and/or biomolecules (e.g., recombinantproteins) (see Terminology F2312). Examples of TEMPs arelisted in C
24、lassification F2211.3.2 ISO 7198 provides basic requirements for sterile vascu-lar prostheses and the methods of testing which will enableevaluation of vascular prostheses. The degree of sterility(sterility assurance level of 1 10-3vs110-6) will bedetermined by the materials of construction and thei
25、r ability tobe sterilized without compromising their function once im-planted.3.3 Throughout this guide, the reader is referred to otherdocuments that may provide specific information that can beapplied in the manufacture and testing of TEMPs. Althoughmany of these documents were not written with TE
26、MPs inmind, parts are often applicable. Most of the potentiallyapplicable position papers and guidance documents from manyregions of the world can be accessed via the internet. Newdocuments are continually produced, and existing documentsare continually updated.3.4 The application of this guide does
27、 not guarantee clinicalsuccess of a finished product but will help develop andcharacterize a given vascular graft TEMP developed for thepurpose of surgically replacing, bypassing or forming shuntsbetween sections of the vascular system.3.5 This guide does not suggest that all listed tests beconducte
28、d. The decision regarding applicability or suitabilityof any particular test method remains the responsibility of thesupplier, user, or regulator of the material based on risk,applicable regulations, characterizations, and preclinical/clinical testing.4. Significance and Use4.1 A common therapy to m
29、itigate the pathological effectsof blood vessel occlusion or aneurysm-related vascular wallweakening is to reroute blood flow around the diseasedvascular regions. Autologous and non-autologous grafts areoften used as vascular substitutes surgically to achieve thistherapeutic intervention. Vascular g
30、raft TEMPs may also beused for these purposes. They may also be used to create orrevise arteriovenous shunts.4.2 Coronary, carotid, renal, common iliac, external iliac,superficial femoral, and popliteal arteries are examples ofvascular sites commonly requiring bypass surgery.4.3 TEMPs may be compose
31、d of biological products (forexample, cells, organs, and tissues), biomaterials (for example,substrates and scaffolds composed of polymers or collagen),biomolecules (for example, recombinant proteins, native/biological proteins, amino acids, peptides, fatty acids, sugarsand other macromolecules) and
32、 various combinations thereof(see Terminology F2312). Examples of TEMPs are listed inClassification F2211.4.4 TEMPs may be used with the intent of facilitating thesurgical outcome by improving the biological repair and/orreconstruction, by accommodating the mechanical loads at therepair site, or by
33、a combination of these mechanisms.4.5 Clinical evidence of improved surgical outcomes mayinclude patency, reduced incidence of revision surgery, reducedrate of implant infection, and improved functionality aftersurgery.5. Synthetic Biomaterials5.1 Polymer TypesThe biomaterial used may be formedfrom
34、synthetic polymers, should elicit an acceptable biologicalresponse with minimal toxicity, and may be degradable ornon-degradable. Examples of degradable polymers areglycolide, lactide, trimethylene carbonate, dioxanone,caprolactone, ortho esters, and polymers and copolymers ofsome of these. Other ex
35、amples of degradable polymers, inorder of fast to slow degradation time, include polyglycolicacid, poly-lactic acid, and polycaprolactone. Non-absorbablematerials include polypropylene, polyethylene, polyamide,polyalkylene terephthalate, polyvinylidene fluoride,polytetrafluoroethylene, and blends an
36、d copolymers of these.Non-synthetic polymers, such as silk, may also be used.F3225 1725.2 StructureThe biomaterial is typically manufacturedinto a structural material appropriate for a vascular TEMPsuchas a sheet or strip or tube, by weaving or knitting using a fiberas a base material, or a felt wit
37、h random fiber orientation, as amembrane, or by using a different technique such as electro-spinning. The structure of the material is selected based on itsrequired function, for example to support cells and matrixdeposition, to provide mechanical support for certain loadingconditions, and/or to int
38、egrate into the surrounding tissues. Forexample, multi-layered biomaterials may be used to conferdesired properties by using layers with distinct capabilities.Two-dimensional structures, such as sheets, may be renderedtubular by suturing while three-dimensional structures may bemanufactured in tubul
39、ar form by casting. Geometries otherthan tubes may be appropriate depending on the implantationanatomic site. Additive manufacturing can be used to createmore complex geometries.5.3 DegradationThe biomaterial may be selected to benon-degradable, or to exhibit specific degradation characteris-tics (e
40、.g., rapidly or slowly degrading) based on the timenecessary for the TEMP to perform its desired function. If thefunction of the material is primarily to support cell attachmentand matrix deposition, the biomaterial may be relativelyrapidly degrading. If the function is to provide mechanicalsupport
41、in vivo, the biomaterial should degrade at a rate thatallows natural repair to occur to a level that enables the newtissue ingrowth to accommodate the mechanical loading at therepair site.6. Extracellular Matrices6.1 Native MatricesHuman- and animal-derived tissuesmay be used to provide an ECM with
42、an appropriate form.Tissues that may be appropriate include, but are not limited to,skin, submucosa, arteries, and veins. The tissue should beprocessed to ensure that cell debris and other immunogenicprocessing reagents are minimized. For human-derived tissues,aseptic processing techniques should be
43、 employed as describedby Freshney (1)6to prevent the introduction or transmission ofcommunicable diseases (also see 21 CFR 1271). For animal-derived tissues or ECM, herd information should be providedand testing should be conducted to confirm that there are nopotential transmissible diseases. Human-
44、 or animal-derivedproteins and glycoproteins such as collagen, elastin,proteoglycans, and hyaluronan may be used. Collagen may bepurified from native tissues (for example, skin, tendon, orligament).The collagen should be made into a biomaterial witha specific shape (for example, tube), and may be cr
45、oss-linkedto maintain its shape and to reduce degradation rates.6.2 Plant-derived biomaterials such as starch and cellulosemay also be used.6.3 Cell culture-derived components: Cells may be main-tained in culture to synthesize ECM components that aresecreted into the tissue culture media. These comp
46、onents mayinclude collagen, elastin, proteoglycans, hyaluronan and otherproteins, and glycoproteins. These components may then beisolated, purified if necessary, and used to develop a biomate-rial with a specific shape (for example, tube), and may becross-linked to maintain its shape and to modulate
47、 degradationrates. Alternatively, cells may be seeded onto a biomaterial,cultured in vitro to synthesize an ECM and then be decellular-ized.6.4 Biomaterials fabricated from combinations of nativematrices, plant-derived matrices, and cell culture-derived pro-teins may be considered. An adverse immuno
48、logic responsemay occur due to the presence of cells or cellular debris.7. Biomaterial Characterization7.1 Biomaterials may be synthetic, non-synthetic or ECM.While biomaterial characterization is beyond the scope of thisdocument, there are several applicable reference documents,including the follow
49、ing: Guide F2210, Guide F2150, andGuide F2212 (also see 21 CFR 1270).8. Cells8.1 Cell TypesThe cell population used may be of one ormultiple cell types such as (a) arterial, venous, or dermalfibroblasts; (b) arterial or venous smooth muscle cells; (c)arterial or venous endothelial cells; (d) stromal cells; or (e)other progenitor cells and may be derived from various tissuesources. These cells are likely to have undergone expansionprior to being seeded into theTEMP, and the cell karyotype andphenotype should be characterized and compared to a popula-tion of fr
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