ASTM F452-1976(2002) Standard Specification for Preformed Cranioplasty Plates《预制头骨形成板》.pdf

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1、Designation: F 452 76 (Reapproved 2002)Standard Specification forPreformed Cranioplasty Plates1This standard is issued under the fixed designation F 452; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、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 plateswhich do not require further alteration for covering skulldefects. This specifi

3、cation covers compositional and physicalperformance and packaging requirements, but does not covertoxicity nor biocompatibility of the materials.2. Referenced Documents2.1 ASTM Standards:F 56 Specification for Stainless Steel Sheet and Strip forSurgical Implants2F 75 Specification for Cobalt-28 Chro

4、mium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)3F 86 Practice for Surface Preparation and Marking of Me-tallic Surgical Implants3F 139 Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Sur-gical Implants (UNS S31673

5、)32.2 American Society for Quality Control (ASQC) Stan-dard:C1-1968 Specifications of General Requirements for aQuality Program43. Materials3.1 Cranioplasty plates conforming to this specificationshall be fabricated from materials described in the latest issueof Specifications F 56, Grade 2, F 75, o

6、r F 139, 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 a

7、lteration, 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 perf

8、orations (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), incl 610 %0.010 (0.25) to 0.020 (0.51), incl 60.0015 (0.04)0.020 (0.51) to 0.035 (0.89), i

9、ncl 60.002 (0.05)0.035 (0.89) to 0.050 (1.27), incl 60.0025 (0.06)0.050 (1.27) to 0.100 (2.54), incl 60.003 (0.08)5. Finish and Identification5.1 Cranioplasty plates conforming to this specificationshall have their surfaces prepared in accordance with the latestissue of Practice F 86. Specific requi

10、rements of surface finish(if any) shall be stated in the purchase order.5.2 The method of marking the plates shall be one of thosespecified in Practice F 86.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibili

11、ty ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved April 5, 1976. Published June 1976.2DiscontinuedSee 1991 Annual Book of ASTM Standards, Vol 13.01.3Annual Book of ASTM Standards, Vol 13.01.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwauke

12、e, WI 53203.FIG. 1 Preformed Cranioplasty Plate1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6. Precautions6.1 Cranioplasty plates covered by this specification shallnot be reshaped in any manner after manufacture.6.2 Material used

13、 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 appropriaterecomm

14、ended 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 includea recommendation against using fasteners o

15、ther 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, fo

16、rexample, defined in ASQC Specifications C 1-1968.9. 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

17、 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 the responsible technical committee and mus

18、t be 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 the

19、responsible 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

20、, West 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 452 76 (2002)2