1、Designation: F 2027 00e1Standard Guide forCharacterization and Testing of Substrate Materials forTissue-Engineered Medical Products1This standard is issued under the fixed designation F 2027; the number immediately following the designation indicates the year oforiginal adoption or, in the case of r
2、evision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.e1NOTETable 1 was editorially corrected in June 2001.1. Scope1.1 This guide addresses material characteristi
3、cs of raw orvirgin materials in a nonfabricated form that will ultimatelyundergo additional processing into growth, support, or deliveryvehicles for cells or biomolecules. This guide does not apply topackaged, sterilized, and finished tissue-engineered medicalproducts.1.2 The purpose of the guide is
4、 to assist the developer oftissue-engineered medical products to locate relevant existingstandards and test methods and to provide guidance for interimuse of materials for which a standard does not exist.2. Referenced Documents2.1 ASTM Standards:D 1763 Specification for Epoxy Resins2D 1898 Practice
5、for Sampling of Plastics3E 1298 Guide for Determination of Purity, Impurities, andContaminants in Biological Drug Products4F 67 Specification for Unalloyed Titanium for SurgicalImplant Applications5F 451 Specification for Acrylic Bone Cement5F 560 Specification for Unalloyed Tantalum for SurgicalImp
6、lant Applications5F 603 Specification for High-Purity Dense Aluminum Ox-ide for Surgical Implant Application5F 604 Specification for Silicone Elastomers Used in Medi-cal Applications5F 624 Guide for Evaluation of Thermoplastic PolyurethaneSolids and Solutions for Biomedical Applications5F 641 Specif
7、ication for Implantable Epoxy Electronic En-capsulants5F 665 Classification for Vinyl Chloride Plastics Used inBiomedical Application5F 702 Specification for Polysulfone Resin for Medical Ap-plications5F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices5F 749 Prac
8、tice for Evaluating Material Extracts by Intracu-taneous Injection in the Rabbit5F 755 Specification for Selection of Porous Polyethylenefor Use in Surgical Implants5F 756 Practice for Assessment of Hemolytic Properties ofMaterials5F 763 Practice for Short-Term Screening of Implant Mate-rials5F 813
9、Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical Devices5F 895 Test Method for Agar Diffusion Cell Culture Screen-ing for Cytotoxicity5F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bon
10、e5F 997 Specification for Polycarbonate Resin for MedicalApplications3F 1088 Specification for Beta-Tricalcium Phosphate forSurgical Implantation5F 1185 Specification for Composition of Ceramic Hydroxy-lapatite for Surgical Implants5F 1251 Terminology Relating to Polymeric Biomaterials inMedical and
11、 Surgical Devices5F 1425 Specification for Virgin Poly (L-lactic Acid) Resinfor Surgical Implants3F 1439 Guide for Performance of Lifetime Bioassay for theTumorigenic Potential of Implant Materials5F 1472 Specification for Wrought Ti-6Al-4V Alloy for Sur-gical Implant Applications5F 1579 Specificati
12、on for Polyaryletherketone (PAEK) Res-ins for Surgical Implant Applications5F 1581 Specification for Composition of Anorganic Bonefor Surgical Implants5F 1634 Practice for In Vitro Environmental Conditioning ofPolymer Matrix Composite Materials and Implant De-vices51This guide is under the jurisdict
13、ion of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.42 on Tissue Characterization.Current edition approved May 10, 2000. Published August 2000.2Annual Book of ASTM Standards, Vol 08.01.3Discontinued; see 1997 Annual Book of ASTM
14、Standards, Vol 08.01.4Annual Book of ASTM Standards, Vol 11.05.5Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.F 1635 Test Method for In Vitro Degradation testing of Poly(L-Lactic Acid) Resin
15、 and Fabricated Forms for SurgicalImplants5F 1855 Specification for Polyoxymethylene Acetal forMedical Applications5F 1876 Standard Specification for Polyetherketoneetherke-toneketone (PEKEKK) Resins for Surgical Implant Appli-cations5F 1926 Test Method for Evaluation of the EnvironmentalStability o
16、f Calcium Phosphate Coatings52.2 Other Document:U.S. Pharmacopeia, Edition XXIII62.3 ISO Standards:7ISO 6474:1994 Implants for Surgery - Ceramic MaterialsBased on AluminaISO 10993-1, Biological Evaluation of Medical DevicesPart 1: Evaluation and testingISO 10993-9Part 9: Framework for identification
17、 andquantification of potential degradation productsISO 10993-12 - Part 12: Sample preparation and referencematerialsISO/DIS 10993-13 - Part 13: Identification and quantifica-tion of potential degradation products from polymericmedical devicesISO/DIS 10993-14 - Part 14: Identification and quantifica
18、-tion of potential degradation products from ceramicsISO/DIS 10993-15Part 15: Identification and quantifica-tion of potential degradation products from metals andalloysISO/DIS 10993-17Part 17: Methods for the establishmentof allowable limits for leachable substances using health-based risk assessmen
19、tISO/CD 10993-18Part 18: Chemical characterization ofmaterialsISO/NWI 10993-19Part 19: Physico-chemical, mechani-cal and morphological characterization of materialsprEN 12442-1 Animal tissues and their derivatives utilizedin the manufacture of medical devicesPart 1: Analysisand management of riskprE
20、N 12442-2Part 2: Controls on sourcing, collection andhandlingprEN 12442-3Part 3: Validation of the elimination and/orinactivation of virus and transmissible agentsISO 111607 Product packaging2.4 Code of Federal Regulations, Title 21, Part 820. FederalRegister Vol. 43, No 141. July 21, 197883. Termin
21、ology3.1 Definitions:3.1.1 natural materials, nsynthesized or produced byliving cells.3.1.2 substrates, nraw or virgin materials that will ulti-mately be used in tissue-engineered medical products forgrowth, support, or delivery of cells or biomolecules.4. Descriptive Chemical and Physical Informati
22、on4.1 The substrate material shall have specifications for anextensive set of chemical and physical properties such as, butnot limited to, those listed in Table 1.4.2 The necessary chemical and physical tests are a functionof the class of material (for example, ceramic, polymer, metal,composite, or
23、natural material). Each type of material hasspecific sets of properties to be specified. Natural polymerssuch as collagen or demineralized bone, and natural ceramicssuch as anorganic bone, are considered a subset of thepolymers and ceramics categories respectively. The followingAAMI, ISO, ASTM, and
24、other recognized voluntary standardscommittee standards, include specific techniques for determin-ing the chemical and physical properties listed in Table 1 andare suggested as guides for new standards development or forinterim use for those materials without existing standards.4.2.1 MetalsSpecifica
25、tion F 1472, Specification F 560,Specification F 67, and ISO/DIS 10993-15 - Part 15.4.2.2 Ceramics, (for example, calcium phosphate, calciumcarbonate, aluminum oxide, glasses) Specification F 603,Specification F 1088, Specification F 1185, SpecificationF 1581, Test Method F 1926, ISO 6474:1994, and
26、ISO/DIS10993-14 - Part 14.4.2.3 PolymersSpecification D 1763, Practice D 1898,Specification F 451, Specification F 604, Guide F 624, Speci-fication F 641, Classification F 665, Specification F 702,Specification F 755, Specification F 997, Terminology F 1251,Specification F 1425, Specification F 1579
27、, Practice F 1634,Test Method F 1635, Specification F 1855, SpecificationF 1876, and ISO/DIS 10993-13 - Part 13.4.2.4 Other General Test MethodsISO/CD 10993-18Part 18, ISO/NWI 10993-19Part 19.4.3 The following web site is suggested as an additionalresource for relevant existing standards: www.fda.go
28、v/cdrh/modact/recstand.html.5. Sampling5.1 It is suggested that the requirements shall be determinedfor each lot of the substrate material by sampling sizes andprocedures in accordance with Practice D 1898 or some otherequivalent.6Available from US Pharmacopia, Vol. 23 Mack Publishing Co., Easton, P
29、A,1995.7Available from the American National Standards Institute, 25 W. 43rd St., 4thFloor, New York, NY 10036.8National Archives and Records Administration, 700 Pennsylvania Ave, NW,Washington, DC 20408.TABLE 1Chemical PhysicalComposition densityPurity molecular weightStability during storage visco
30、sityAdditives compresseion strengthTrace elements tension strengthExtractables (metals orsolvents)elastic modulusDegradation kinetics fatigue strengthResorption kinetics yield strengthResorption kinetics hardnessDegradation products foreign particlesstructure - long range- short rangeF 202726. Handl
31、ing, Packaging, and Labeling6.1 The product should be handled and packaged as speci-fied in USP 661 or ISO 111607 and prEN 12442-2 Part 2,and ISO 111607.7. Quality Program Requirements7.1 The manufacturer should conform to Quality SystemsRegulations (see CFR 21, Part 820) or its equivalent.8. Biocom
32、patibility8.1 Many materials have been shown to produce a well-characterized level of biological response following long-termclinical use in laboratory animals. When new applications of amaterial, or modifications to the material or physical forms ofthe material, are being considered, then the recom
33、mendationsand test methods of the following standards should be consid-ered: Practice F 748, F 619, Practice F 749, Practice F 756,Practice F 763, Practice F 813, Practice F 981, and GuideF 1439-92 as well as Test Method F 895, ISO 10993-1,ISO/DIS 10993-9, Part 9, ISO/DIS 10993-17 - Part 17, prEN124
34、42-1 Part 1, and prEN 12442-3 Part 3.9. Keywords9.1 biomaterials; ceramics; composites; materials; metals;polymers; substrates; tissue-engineered medical productsASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this st
35、andard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be rev
36、iewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsi
37、ble technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 20273
