ASTM F1185-2003(2014) Standard Specification for Composition of Hydroxylapatite for Surgical Implants《外科植入物用羟基磷灰石成分的标准规范》.pdf

1、Designation: F1185 03 (Reapproved 2014)Standard Specification forComposition of Hydroxylapatite for Surgical Implants1This standard is issued under the fixed designation F1185; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the ye

2、ar 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 im

3、-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 includes

4、 powder, particulate, andforms intended for use as surgical implants, components ofsurgical implants, or as raw materials for manufacturingprocesses such as thermal spray coating, electrophoreticdeposition, physical vapor deposition, and so forth.1.4 This specification specifically excludes hydroxyl

5、apatitecoatings, amorphous calcium phosphate, ceramic-glasses,tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F1088.)1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 T

6、his 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 Docume

7、nts2.1 ASTM Standards:3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1088 Specification for Beta-Tricalcium Phosphate for S

8、ur-gical ImplantationF2024 Practice for X-ray Diffraction Determination of PhaseContent of Plasma-Sprayed Hydroxyapatite Coatings2.2 Code of Federal Regulations:4Title 21, Part 820.2.3 National Formulary:5Tribasic Calcium Phosphate2.4 United States Pharmacopeia:6Identification Tests for Calcium and

9、Phosphate Lead Mercury Arsenic Heavy Metals Method 12.5 U. S. Geological Survey Method:7Cadmium2.6 American Society for Quality:8C1 Specification of General Requirements for a QualityProgram3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 hydroxylapatitethe chemical substance h

10、aving theempirical formula Ca5(PO4)3OH.94. Chemical Requirements4.1 Elemental analysis for calcium and phosphorus will beconsistent with the expected stoichiometry of hydroxylapatite.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and

11、is the direct responsibility ofSubcommittee F04.13 on Ceramic Materials.Current edition approved March 1, 2014. Published March 2014. Originallyapproved in 1988. Last previous edition approved in 2009 as F1185 03 (2009).DOI: 10.1520/F1185-03R14.2The boldface numbers in parentheses refer to the list

12、of references at the end ofthis specification.3For referenced 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.4Available from

13、 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. PharmacopeiaConvention, Inc., 12601 Twinbrook P

14、arkway, 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, Vol 7,

15、1983, pp. 335-340.8Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.9Chemical Abstracts Service Registry Number 1306-06-5.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1

16、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 inaccordance with Practice F2024. Analysis of relative peakintensities shall b

17、e consistent with published data.104.3 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/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods listed in 2.4

18、 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 limit of all heavy metalsdetermined as lead will be 50 ppm as described in 2.4 oreq

19、uivalent. 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 and boiled.4.5 It is recommended that all metals or oxides not detectedas lead p

20、resent 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-mended in Practices F748 and F981 as appropriate.6. Test Specimen Fabrication6.1 Pre

21、pare 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 ManufacturingPractices (2.2) or its equivalent.7.2 The manufacturer shall maintain a quali

22、ty program,such as the program defined in ASQ C1 (2.6) or equivalent.8. Keywords8.1 bioceramic; bone graft; hydroxylapatite (HA); hydroxy-apatite; tricalcium phosphate (TCP); whitlockiteAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 Hydroxylapatite is commercially available as a syn-thetic bo

23、ne-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 provides specificationsfor a biocompatible grade of hydroxylapatite. Trace elementco

24、ntent 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 mechanical properties were not specified. Asource of general test methods for ceramics may

25、be found inRef (7).10The Joint Committee on Powdered Diffraction Standards has established aPowder Diffraction File. The Committee operates on an international basis andcooperates closely with the Data Commission of the International Union ofCrystallography and ASTM (American Society for Testing and

26、 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.F1185 03 (2014)2X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever beenshown to be completely free

27、 of adverse reactions in the humanbody. However, long-term clinical experience has shown thatan acceptable level of biological response can be expected ifthe materials are used in appropriate applications.REFERENCES(1) Cranin, A. N., Tobin, G., Gelbman, J., Varjan, R., “A Seven YearFollow-up of Pati

28、ents with (H/A)Ridge Augmentation,” 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 NonresorbableHydroxylapatite or with Autogenous Cancellous Bone,” Journal ofOral and Max

29、illofacial 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,” Journal of Periodontology, Vol 55 ( 11),1984, pp. 633-637.(4) Jarcho, M., Kay,

30、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, S. S., Gumaer, K. I., Sherer, A. D., andSlighter, R. G., “Histologic Observat

31、ion 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 MicroscopyStudies of the Bone-Hydroxylapatite Interface,” Journal of Biomedi-cal M

32、aterials 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 this standard. Users of this standard are expressly advised that determination

33、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 reviewed every five years andif not revised, either reapproved or withdrawn

34、. 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 theresponsible technical committee, which you may attend. If you feel that your com

35、ments 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

36、 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F1185 03 (2014)3