ASTM_F_622_-_79_2002.pdf

Designation:F 622 79(Reapproved 2002)Standard Specification forPreformed Cranioplasty Plates That Can Be Altered1This standard is issued under the fixed designation F 622;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,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.1.Scope1.1 This specification covers preformed cranioplasty platesthat allow alteration for covering skull defects.2.Referenced Documents2.1 ASTM Standards:F 67 Specification for Unalloyed Titanium(UNS R50250,UNS R50400,UNS R50550,R50700)for Surgical ImplantApplications2F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants2F 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)2F 136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy(UNSR56401)for Surgical Implant Applications22.2ASQC Standard:C1-1968 Specifications of General Requirements for aQuality Program33.Terminology3.1 Definition:3.1.1 cranioplasty platean implanted prosthetic deviceused to repair or cover a skull defect or hole.4.Materials4.1 Cranioplasty plates conforming to this specificationshall be fabricated from one of the materials covered by thefollowing ASTM specifications or other such materials foundacceptable for neurosurgical procedures only:F 67,F 90,andF 136.5.Dimensions and Tolerances5.1 Cranioplasty plates conforming to this specificationshall be fabricated in a variety of dimensions to accommodatevarious sized skull defects.These plates may be altered in theoperating room by the neurosurgeon in order to fit a particularskull defect.5.2 The shape of the plate shall be contoured so as toreestablish the normal configuration and symmetry of the skullat various anticipated sites of defect,such as the parietalbosses,the inion,the brow,the linea temporalis,and so forth.5.3 Plates shall contain multiple perforations.5.4 Thickness and individual shapes shall vary with need.Thickness tolerances shall be as follows:Specified Thickness,in.(mm)Tolerances,in.(mm)0.020(0.51)to0.035(0.89),incl60.002(0.05)0.035(0.89)to0.050(1.27),incl60.0025(0.06)0.050(1.27)to0.100(2.54),incl60.003(0.08)5.5 For plates that are cast or hand-wrought,the establish-ment of tolerances is not practical and is the responsibility ofthe implant manufacturer.6.Finish and Identification6.1 Cranioplasty plates conforming to this specificationshall be finished in accordance with Practice F 86.6.2 Cranioplasty plates conforming to this specificationshall be identified as to the material used for fabrication,in amanner in accordance with Practice F 86.6.3 Tantalum cranioplasty plates shall be cleaned using atantalum etching solution.6.3.1 Prepare the tantalum etching solution as follows:Hydrofluoric acid(H2F2)48 vol%4 partsSulfuric acid(H2SO4)98 vol%6 partsNitric acid(HNO3)70 vol%3 partsWater13 parts6.3.2 Use the tantalum etching solution at room temperaturefor a period of 15 min(Note 1).Wash with water immediately.(WarningThe use of this solution should be under a hood asthe fumes are toxic.)NOTE1The 15-min dip followed by a water bath is necessary to cleanthe tantalum cranioplasty plates.7.Precautions7.1 When metallic sutures or screws are used to fasten the1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved March 30,1979.Published May 1979.2Annual Book of ASTM Standards,Vol 13.01.3Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.cranioplasty plates covered by this specification,they shall beof the same metallic composition as the specific plate beinginstalled.8.Packaging and Labeling8.1 Cranioplasty plates conforming to this specificationshall be packaged in accordance with federal regulationsappropriate for such devices.8.1.1 An insert shall be included in the package for the plateidentifying the material from which it was fabricated.Arecommendation against the use of fasteners other than thesame material to secure the plate shall also be included.8.1.2 Labeling shall include the nominal thickness of theplate.9.Quality Program Requirements9.1 The manufacturer of cranioplasty plates covered by thisspecification shall maintain a quality program such as definedin ASQC C1-1968.10.Keywords10.1 cranioplasty plates;neurosurgical medical devices/applicationsASTM 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 s