ASTM F1185-2003 Standard Specification for Composition of Hydroxylapatite for Surgical Implants《外科植入物用羟基磷灰石构成的标准规范》.pdf

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1、Designation: F 1185 03Standard Specification forComposition of Hydroxylapatite for Surgical Implants1This standard is issued under the fixed designation F 1185; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revis

2、ion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers chemical and crystallographicrequirements for hydroxylapatite intended for surgical im-plants. For a

3、material to be called hydroxylapatite, it mustconform to this specification. (See Appendix X1.)1.2 The biological response to hydroxylapatite in soft tissueand bone has been characterized by a history of clinical use(1-3)2and by laboratory studies (4-6).1.3 This specification includes powder, partic

4、ulate, andforms intended for use as surgical implants, components ofsurgical implants, or as raw materials for manufacturingprocesses such as thermal spray coating, electrophoretic depo-sition, physical vapor deposition, and so forth.1.4 This specification specifically excludes hydroxylapatitecoatin

5、gs, amorphous calcium phosphate, ceramic-glasses,tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.)2. Referenced Documents2.1 ASTM Standards:F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices3F 981 Pract

6、ice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone3F 1088 Specification for Beta-Tricalcium Phosphate forSurgical Implantation3F 2024 Practice for X-Ray Diffraction Determination ofPhase Content of Plasma-Sprayed Hydroxyap

7、atite Coat-ings32.2 Code of Federal Regulations:4Title 21, Part 820.2.3 National Formulary:5Tribasic Calcium Phosphate2.4 United States Pharmacopeia:6Identification Tests for Calcium and Phosphate Lead Mercury Arsenic Heavy Metals Method 12.5 U. S. Geological Survey Method:7Cadmium2.6 American Socie

8、ty for Quality:8C1 Specification of General Requirements for a QualityProgram3. Terminology3.1 Descriptions of Terms Specific to This Standard:3.1.1 hydroxylapatitethe chemical substance having theempirical formula Ca5(PO4)3OH.94. Chemical Requirements4.1 Elemental analysis for calcium and phosphoru

9、s will beconsistent with the expected stoichiometry of hydroxylapatite.The calcium and phosphorus contents shall be determinedusing a suitable method such as ion chromatography.4.2 A quantitative X-ray diffraction analysis shall indicate aminimum hydroxylapatite content of 95 % as determined inaccor

10、dance with Practice F 2024. Analysis of relative peakintensities shall be consistent with published data.101This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Curr

11、ent edition approved Apr. 10, 2003. Published May 2003. Originallyapproved in 1988. Last previous edition approved in 1993 as F 4485 88 (1993)e1.2The boldface numbers in parentheses refer to the list of references at the end ofthis specification.3Annual Book of ASTM Standards, Vol 13.01.4Available f

12、rom U.S. Government Printing Office, N. Capitol and H St., NW,Washington, DC 20402.5National Formulary XVI. Available from U.S. Pharmacopeia Convention, Inc.,12601 Twinbrook Parkway, Rockville, MD 20852.6United States Pharmacopeia XXI. Available from U.S. Pharmacopeia Conven-tion, Inc., 12601 Twinbr

13、ook Parkway, Rockville, MD 20852.7Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements inNational Bureau of Standards Geological Reference Materials SRM 278 Obsidianand SRM 688 Basalt by Inductively Coupled Argon PlasmaAtomic EmissionSpectrometry,” Geostandards Newsletter, Vo

14、l 7, 1983, pp. 335-340.8Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203.9Chemical Abstracts Service Registry Number 1306-06-5.10The Joint Committee on Powdered Diffraction Standards has established aPowder Diffraction File. The Committee operates on an i

15、nternational basis andcooperates closely with the Data Commission of the International Union ofCrystallography and ASTM (American Society for Testing and Materials). Hy-droxylapatite data can be found on file card number 9-432 and is available from theJoint Committee on Powder Diffraction Standards,

16、 1600 Park Lane, Swarthmore,PA 19081.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.3 For hydroxylapatite derived from natural sources, theconcentration of trace elements shall be limited as follows:Element ppm, maxAs 3Cd 5Hg 5Pb

17、30Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods listed in 2.4 and2.5 shall be used.4.3.1 The analysis of other trace elements may be required,based on the conditions, apparatus, or environments specific tothe manufacturing techniques and raw ma

18、terials.4.4 The maximum allowable limit of all heavy metalsdetermined as lead will be 50 ppm as described in 2.4 orequivalent. Sample preparation will be identical to that fortribasic calcium phosphate as specified in the National Formu-lary (2.3) except that approximately1gofmaterial will bedissolv

19、ed in approximately 30 mL of 5 % HCl and boiled.4.5 It is recommended that all metals or oxides not detectedas lead present in concentrations equal to or greater than 0.1 %be listed on the package insert.5. Biocompatibility5.1 Before any new device is used clinically, the tissueresponse should be ch

20、aracterized by the methods recom-mended in Practices F 748 and F 981 as appropriate.6. Test Specimen Fabrication6.1 Prepare test specimens from the same batch of materialand by the same processes as those employed in fabricating theceramic implant device.7. Quality Program Requirements7.1 The manufa

21、cturer shall conform to Good ManufacturingPractices (2.2) or its equivalent.7.2 The manufacturer shall maintain a quality program,such as the program defined in ASQ C1 (2.6) or equivalent.8. Keywords8.1 bioceramic; bone graft; hydroxylapatite (HA); hy-droxyapatite; tricalcium phosphate (TCP); whitlo

22、ckiteAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Hydroxylapatite is commercially available as a syn-thetic bone-grafting material. As with any implant material, thebioresponse is critically dependent upon the material proper-ties. To achieve reliable biocompatibility these must be knownand

23、 consistent. This material standard provides specificationsfor a biocompatible grade of hydroxylapatite. Trace elementcontent and physical form must be within established biocom-patibility standards.X1.2 It is recognized that a separate performance standardmay be necessary for each end-use product.

24、For this reason,physical and mechanical properties were not specified. Asource of general test methods for ceramics may be found inRef (7).X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long-term cl

25、inical experience has shown thatan acceptable level of biological response can be expected ifthe materials are used in appropriate applications.F1185032REFERENCES(1) Cranin, A. N., Tobin, G., Gelbman, J., Varjan, R., “A Seven YearFollow-up of Patients with (H/A) Ridge Augmentation,” Transactionsof t

26、he Society for Biomaterials, 1986, p. 155.(2) Kent, J. N., Quinn, J. H., Zide, M. F., Guerra, L. R., Boyne, P.,“Augmentation of Deficient Alveolar Ridges with NonresorbableHydroxylapatite or with Autogenous Cancellous Bone,” Journal ofOral and Maxillofacial Surgery, Vol 41 (10), 1983, pp. 629-642.(3

27、) Yukna, R. A., Mayer, E. T., Brite, D. V., “Longitudinal Evaluation ofDurapatite Ceramic as an Alloplastic Implant in Periodontal OsseousDefects After Three Years,” Journal of Periodontology, Vol 55 (11),1984, pp. 633-637.(4) Jarcho, M., Kay, J. F., Gumaer, K. I., Doremus, R. H., and Drobeck, H.P.,

28、 “Tissue, Cellular and Subcellular Events at a Bone-CeramicHydroxylapatite Interface,” Journal of Bioengineering, Vol 1, 1977,pp. 79-92.(5) Drobeck, H. P., Rothstein, S. S., Gumaer, K. I., Sherer, A. D., andSlighter, R. G., “Histologic Observation of Soft Tissue Responses toImplanted, Multifaceted P

29、articles and Discs of Hydroxylapatite,”Journal of Oral and Maxillofacial Surgery, Vol 42, 1984, pp. 143-149.(6) Tracy, B. M. and Doremus, R. H., “Direct Electron MicroscopyStudies of the Bone-Hydroxylapatite Interface,” Journal of BiomedicalMaterials Research, Vol 18, 1984, pp. 719-726.(7) Annual Bo

30、ok of ASTM Standards, Vol 15.02.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof

31、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 reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this st

32、andard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your

33、 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).F1185033