ASTM F1088-2018 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation.pdf

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1、Designation: F1088 04a (Reapproved 2010)F1088 18Standard Specification forBeta-Tricalcium Phosphate for Surgical Implantation1This standard is issued under the fixed designation F1088; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision

2、, 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 specification covers chemical and crystallographic requirements for biocompatible beta-tricalcium p

3、hosphate (-TCP)for surgical implant applications. For a material to be identified as medical grade medical-grade beta-tricalcium phosphate, it mustconform to this specification (see Appendix X1).1.2 This international standard was developed in accordance with internationally recognized principles on

4、 standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biolog

5、ical Test Methods for Materials and DevicesF981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials onMuscle and Insertion into Bone2.2 American Society for Quality (ASQ) Document:3C1 Specification of General Requirements for a Quality P

6、rogram2.3 International Organization for Standardization Document:4ISO 1099310993-1 Biological Evaluation of Medical Devices Part 1: Evaluation Within a Risk Management System2.4 United States Pharmacopeia (USP) Documents:5Identification Tests for Calcium and Phosphate USP Identification Tests for C

7、alcium and PhosphateLead USP United States Pharmacopeia: Elemental Impurities LimitsMercury USP United States Pharmacopeia: Elemental Impurities ProcedureArsenic Heavy Metals Method 12.5 Other Reference:ICH Document:6U.S. Geological Survey MethodICH Q3D International Conference on Harmonization of T

8、echnical Requirements forRegistration of Pharmaceuticals for Human Use: Guideline for Elemental Impurities3. Chemical Requirements3.1 Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalciumphosphate (Ca3(PO4)2. The calcium and phosphorus co

9、ntent shall be determined using a suitable method such as USP (see2.4) or X-ray fluorescence.1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.13 on Ceramic Materials.Current edition a

10、pproved Sept. 1, 2010Nov. 15, 2018. Published November 2010 January 2019. Originally approved in 1987. Last previous edition approved in 20042010as F1088 04a 1.(2010). DOI: 10.1520/F1088-04AR10.10.1520/F1088-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Custo

11、mer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http:/www.asq.org.4 Available from American National

12、 Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.5 Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http:/www.usp.org.6 Crock, J. G., Felichte, F. E., and Briggs, P. H., “Determination of Elements in National Burea

13、us of Standards Geological Reference Materials SRM 278 Obsidian andSRM 688 Basalt by Inductively Coupled PlasmaAtomic Emission Spectrometry,” Geostandards Newsletter, Vol 7, 1983, pp. 335340.Available from ICH Secretariat, c/oIFPMA, 30 rue de St-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland. Avail

14、able online at http:/www.ich.org/LOB/media/MEDIA423.pdf.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes

15、accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United

16、 States13.2 Aquantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95 % as determinedusing Powder Diffraction File #5508987 and a method equivalent to Forman8 or Rietveld.9,103.3 For beta-tricalcium phosphate, the concentration of trace elements shall

17、be limited as follows:Elemental Impurities:ElementOther Metals ppm, maxPb 30Hg 5As 3Cd 5Inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption spectroscopy (AAS), or the methods listed in 2.4and 2.5 shall be used.3.3.1 The analysis of other trace elements may be required, based on

18、the conditions, apparatus, or environments specific to themanufacturing techniques and raw materials.significance of elemental impurities within an absorbable material is ultimatelydependent on the dimensional characteristics of the final product and the rate of release of those initially interstiti

19、al elements intothe surrounding tissue and extracelluar fluid. Thus, any risk assessment of such impurities will be dependent on the final productdesign and intended application. Consequently, this raw material (not final device) standard provides for appropriate reporting ofelemental impurities val

20、ues, but does not mandate any specific performance requirements. More detailed and pharmaceutical-oriented guidance regarding the appropriate means for both monitoring and assessing relevant elemental impurities within a finalproduct can be found in USP Chapters and and ICH Q3D.3.3.2 Determine the c

21、oncentration of the respective elemental impurities within the beta-TCP by utilizing inductively coupledplasma mass spectroscopy (ICP-MS) or inductively coupled plasma atomic or optical emission spectroscopy (ICP-AES orICP-OES) or an equivalent alternative method as described in USP Chapter . The sp

22、ecific 24 different elemental impuritiesof interest are outlined in both USP and in TableA.2.2 of ICH Q3D. Both of these documents include risk-based approachestoward the assessment and control of elemental impurities.3.3.3 Except for intentionally added elements, assess the obtained results for com

23、pliance with the Parenteral Concentrationlimits described within the Individual Component Option of USP , Table 3 (derived from ICH Q3D Option 1, Table A.2.2).If all listed elements except for those that are intentionally added can be assured to be maintained within the ParenteralConcentration Indiv

24、idual Component Option limits, the material “conforms” to USP . If any listed element (other thanthose intentionally added) cannot be controlled to be maintained within the prescribed USP limits, the material does notconform with USP and the concentration (in ppm, per USP or equivalent) of each unco

25、ntrolled element shall be bothmonitored and reported.3.3.4 For each intentionally added element, the concentration (in ppm, per USP or equivalent) shall be both monitoredand reported.3.3.5 The elemental impurities thresholds for the Individual Component Option of USP , Table 3, provide specificeleme

26、ntal daily dosage limits for parenteral drug products. These daily elemental impurity limits (including those applied tointentionally added elements) should be considered as conservative thresholds for informational purposes only when applied toabsorbable implants. Proper application of these limits

27、 in setting raw material specifications should consider the amount of -TCPin the final implant product as well as its degradation and elemental elution rate into the surrounding tissue.3.3.5.1 The elemental impurity content of -TCP raw materials used in implants with a successful clinical history ma

28、y also beconsidered in setting limits for raw material specifications. For such data to be relevant, analyses shall be consistent with themethods of USP and shall be conducted on raw material lots used for clinically released product.3.3.6 See X2.2 for additional information.3.4 The maximum allowabl

29、e limit of all heavy metals determined as lead will be 50 ppm as described in 2.4 or equivalent.Sample preparation will be identical to that for tribasic calcium phosphate as specified in the National Formulatory (see 2.4).3.4 It is recommended that all metals or oxides present in concentrations equ

30、al or greater than 0.1 % be noted in materialdescriptions.4. Quality Program Requirements4.1 The producer shall maintain a quality program, such as the program defined in ASQ C1.5. Keywords5.1 advanced ceramics; -TCP; beta-tricalcium phosphate; calcium phosphate material; ceramic; surgical implant7

31、International Centre for Diffraction Data, 12 Campus Blvd, Newtown Square, PA 19073-3273.8 Forman, D.W. and Metsger, D. S., “The Determination of Phase Composition of Calcium Phosphate Ceramics by X-Ray Diffraction,” Transactions of the Seventh AnnualMeeting of the American Society for Bone and Mine

32、ral Research, Kelseyville, CA, 1985 p. 391.9 Jackson, L. E., Barralet, J. E., and Wright,A. J., “RietveldAnalysis in Sintering Studies of Ca-Deficient Hydrxyapatite,”Bioceramics 16, Key Engineering Materials, Vols254-256, 2004, pp.297300.10 Rietveld, H. M., Acta Crystallogr., Vol 22, 1967, p. 151.F1

33、088 182APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification is needed to ensure a high quality material for use in medical device applications. The chemical,crystallographic, and phase requirements serve as criteria for a high-purity, consistent product that can be implanted in t

34、he body.These requirements provide specifications for biocompatible grades of beta-tricalcium phosphate for use in the physiologicalenvironments.X1.2 It is recognized that a separate performance standard may be necessary for each end-use product. For this reason, physicaland mechanical properties we

35、re not specified. A source of general test methods for ceramics may be found in Vol 15.02 of theAnnual Book of ASTM Standards.X2. BIOCOMPATIBILITYX2.1 This specification is needed to ensure a high quality material for use in biological applications. beta-tricalciumBeta-tricalcium phosphate has been

36、demonstrated to exhibit a well characterized biological response equivalent to or better than thatexhibited by reference materials cited and tested in Practices F981 and F748 or equivalent. The chemical, crystallographic, andphase requirements contained in this specification serve as criteria for a

37、high purity, high-purity, consistent product that can beimplanted in the body. The suitability of the material from a human implant perspective is dependent on the specific application.The biological testtests appropriate for the specific site, such as recommended in Practice F748 or ISO 1099310993-

38、1 should beused as a guideline. Further testing of specific properties may be required for specific applications.X2.2 Elemental Impurities LimitsThe USP Heavy MetalsTest was obsoleted on December 1, 2017 and has been replacedwith USP , which outlines acceptable analytical methods for determining the

39、 concentrations of individual elementalimpurities. USP describes a risk-based approach to setting limits on elemental impurities for pharmaceuticals. Whilemedical devices are not within the scope of USP , the limits set for parenteral drugs can be applied to absorbable materialsby estimating the rel

40、ease rate of elemental impurities based on their concentrations and the degradation rate of the device. If theconcentration of an elemental impurity within the material conforms to the Parenteral Concentration Individual ComponentOption limits of USP then no risk analysis is needed. The term heavy m

41、etals has been dropped in favor of elementalimpurities in keeping with ICH Q3D. The term heavy metals is imprecise and there is confusion as to exactly which elements areincluded. Furthermore, the USP Heavy Metals Test is based on the reaction of various metal cations with sulfide and,therefore, can

42、not distinguish between those elements. It is also a limit test, meaning that it can only determine whether the totalconcentration of metals is less than or greater than a pre-set value, which is assumed to be lead. In contrast, ICH Q3D lists 24elements of interest, which are categorized according t

43、o their toxicities, with individual limit values varying accordingly. Themethods outlined in USP are quantitative and highly sensitive, so the concentration of each element of interest can bedetermined. This provides more detailed information that allows a more robust risk analysis with fewer conser

44、vative assumptions.Previous versions of this specification allowed up to 30 ppm lead, 5 ppm mercury, 5 ppm cadmium, 3 ppm arsenic, and 50 ppmtotal heavy metals (as determined by USP). No rationale for those requirements was given and they were not consistent withthe requirements of other standards f

45、or absorbable materials. Furthermore, the release rate of an impurity will be dependent upona number of factors including phase chemistry, physical exposure of the impurity to the environment, and implant location.ASTM International takes no position respecting the validity of any patent rights asse

46、rted 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 infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by

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