ASTM F1185-2003(2009) 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 03 (Reapproved 2009)Standard 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

2、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 specification covers chemical and crystallographicrequirements for hydroxylapatite intended for surgical

3、im-plants. For a 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 includ

4、es powder, particulate, 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 hydr

5、oxylapatitecoatings, amorphous calcium phosphate, ceramic-glasses,tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.)1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.

6、1.6 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 regulatory limitations prior to use.2. Referenced D

7、ocuments2.1 ASTM Standards:3F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF 1088 Specification for Beta-Tricalcium Phosp

8、hate forSurgical ImplantationF 2024 Practice for X-ray Diffraction Determination ofPhase Content of Plasma-Sprayed Hydroxyapatite Coat-ings42.2 Code of Federal Regulations:5Title 21, Part 820.2.3 National Formulary:6Tribasic Calcium Phosphate2.4 United States Pharmacopeia:7Identification Tests for C

9、alcium and Phosphate Lead Mercury Arsenic Heavy Metals Method 12.5 U. S. Geological Survey Method:8Cadmium2.6 American Society for Quality:9C1 Specification of General Requirements for a QualityProgram3. Terminology3.1 Descriptions of Terms Specific to This Standard:3.1.1 hydroxylapatitethe chemical

10、 substance having theempirical formula Ca5(PO4)3OH.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.Current edition approved June 15, 2009. Published July 200

11、9. Originallyapproved in 1988. Last previous edition approved in 2003 as F 1185 03.2The boldface numbers in parentheses refer to the list of references at the end ofthis specification.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm

12、.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.5Available from U.S. Government Printing Office, N. Capitol and H St., NW,Washingt

13、on, DC 20402.6National Formulary XVI. Available from U.S. Pharmacopeia Convention, Inc.,12601 Twinbrook Parkway, Rockville, MD 20852.7United States Pharmacopeia XXI. Available from U.S. Pharmacopeia Conven-tion, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.8Crock, J. G., Felichte, F. E., and B

14、riggs, 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, Vol 7, 1983, pp. 335-340.9Available from American Society for Quality (A

15、SQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.10Chemical Abstracts Service Registry Number 1306-06-5.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4. Chemical Requirements4.1 Elemental analysis for calcium and

16、phosphorus 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 determine

17、d inaccordance with Practice F 2024. Analysis of relative peakintensities shall be consistent with published data.114.3 For hydroxylapatite derived from natural sources, theconcentration of trace elements shall be limited as follows:Element ppm, maxAs 3Cd 5Hg 5Pb 30Either inductively coupled plasma/

18、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 materials.4.4 The maximum allowable li

19、mit 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 bedissolved in approximately 30 mL of 5 % HCl

20、 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 characterized by the methods recom-men

21、ded 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 manufacturer shall conform to Good Manufac

22、turingPractices (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); whitlockiteAPPENDIXES(Nonmandatory Informa

23、tion)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 consistent. This material standard p

24、rovides 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. For this reason,physical and mechanic

25、al 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 clinical experience has shown thatan ac

26、ceptable level of biological response can be expected ifthe materials are used in appropriate applications.11The Joint Committee on Powdered Diffraction Standards has established aPowder Diffraction File. The Committee operates on an international basis andcooperates closely with the Data Commission

27、 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, 1600 Park Lane, Swarthmore,PA 19081.F 1185 03 (2009)2REFERENCES(

28、1) Cranin, A. N., Tobin, G., Gelbman, J., Varjan, R., “A Seven YearFollow-up of Patients with (H/A)RidgeAugmentation,” Transactionsof the 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 Nonres

29、orbableHydroxylapatite or with Autogenous Cancellous Bone,” Journal ofOral and Maxillofacial Surgery, Vol 41 (10), 1983, pp. 629-642.(3) Yukna, R. A., Mayer, E. T., Brite, D. V., “Longitudinal Evaluation ofDurapatite Ceramic as an Alloplastic Implant in Periodontal OsseousDefects After Three Years,”

30、 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., “Tissue, Cellular and Subcellular Events at a Bone-CeramicHydroxylapatite Interface,” Journal of Bioengineering, Vol 1, 1977,pp. 79-92.(5) Drobeck, H. P., Rothstein

31、, S. S., Gumaer, K. I., Sherer, A. D., andSlighter, R. G., “Histologic Observation of Soft Tissue Responses toImplanted, Multifaceted Particles 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 Micr

32、oscopyStudies of the Bone-Hydroxylapatite Interface,” Journal of BiomedicalMaterials Research, Vol 18, 1984, pp. 719-726.(7) Annual Book 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 thi

33、s standard. 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

34、 reviewed 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 theresp

35、onsible 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, We

36、st 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 1185 03 (2009)3