ASTM_F_452_-_76_2014.pdf

Designation:F45276(Reapproved 2014)Standard Specification forPreformed Cranioplasty Plates1This standard is issued under the fixed designation F452;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers preformed cranioplasty plateswhich do not require further alteration for covering skulldefects.This specification covers compositional and physicalperformance and packaging requirements,but does not covertoxicity nor biocompatibility of the materials.2.Referenced Documents2.1 ASTM Standards:2F56 Specification for Stainless Steel Sheet and Strip forSurgical Implants(Withdrawn 1989)3F75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Sur-gical Implants(UNS S31673)2.2 American Society for Quality(ASQ)Standard:ASQ C1 Specifications of General Requirements for a Qual-ity Program43.Materials3.1 Cranioplasty plates conforming to this specificationshall be fabricated from materials described in the latest issueof Specifications F56,Grade 2,F75,or F139,Grade 2.Thecondition of the material(such as,annealed,cold finished,andso forth)should be specified in the purchase order.4.Dimensions and Tolerances4.1 Cranioplasty plates conforming to this specificationshall be fabricated in a variety of dimensions to accommodate,without further alteration,various sized skull defects.4.2 Shape shall be contoured so as to re-establish the normalconfiguration and symmetry of the skull at various anticipatedsites of defect such as the parietal bosses,the inion,the brow,the linea temporalis,and so forth.4.3 Plates shall contain multiple perforations(see Fig.1).4.4 Thicknesses and individual shapes shall vary with need.Thickness tolerances shall be as follows:Specified Thickness,in.(mm)Thickness Tolerances,in.(mm)0.005(0.13)to 0.010(0.25),incl10%0.010(0.25)to 0.020(0.51),incl0.0015(0.04)0.020(0.51)to 0.035(0.89),incl0.002(0.05)0.035(0.89)to 0.050(1.27),incl0.0025(0.06)0.050(1.27)to 0.100(2.54),incl0.003(0.08)5.Finish and Identification5.1 Cranioplasty plates conforming to this specificationshall have their surfaces prepared in accordance with the latestissue of Practice F86.Specific requirements of surface finish(ifany)shall be stated in the purchase order.5.2 The method of marking the plates shall be one of thosespecified in Practice F86.6.Precautions6.1 Cranioplasty plates covered by this specification shallnot be reshaped in any manner after manufacture.6.2 Material used to fasten the cranioplasty plates coveredby this specification shall be the same alloy as the material usedto make the specific plate being installed.7.Packaging and Labeling7.1 Cranioplasty plates conforming to this specificationshall be supplied,packaged in accordance with the appropriaterecommended practice being developed by ASTM CommitteeF04.Minimum packaging and labeling for cranioplasty platesshall include the following:7.1.1 An insert shall be included in the package for the plateshowing the material from which it was fabricated and include1This 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 Oct.1,2014.Published November 2014.Originallyapproved in 1976.Last previous edition approved in 2008 as F452 76(2008).DOI:10.1520/F0452-76R14.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from American Society for Quality(ASQ),600 N.Plankinton Ave.,Milwaukee,WI 53203,http:/www.asq.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 a recommendation against using fasteners other than the samematerial or a recommended substitute to secure the plate whenimplanted.7.1.2 Labeling shall include the nominal thickness of theplate.8.Quality Program Requirements8.1 The manufacturer of cranioplasty plates covered by thisspecification shall maintain a quality program such as,forexample,defined in ASQ C1.9.Keywords9.1 cranioplasty plates;neurosurgical medical devices/applications;orthopaedic medical devices;bone platesASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard.Users of this