ASTM F452-76(2002)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F 452 – 76 (Reapproved 2002)
Standard Specification for
Preformed Cranioplasty Plates
This standard is issued under the fixed designation F 452; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Dimensions and Tolerances
1.1 This specification covers preformed cranioplasty plates 4.1 Cranioplasty plates conforming to this specification
which do not require further alteration for covering skull shall be fabricated in a variety of dimensions to accommodate,
defects. This specification covers compositional and physical without further alteration, various sized skull defects.
performance and packaging requirements, but does not cover 4.2 Shape shall be contoured soas to re-establishthenormal
toxicity nor biocompatibility of the materials. configuration and symmetry of the skull at various anticipated
sites of defect such as the parietal bosses, the inion, the brow,
2. Referenced Documents
the linea temporalis, and so forth.
2.1 ASTM Standards:
4.3 Plates shall contain multiple perforations (see Fig. 1).
F 56 Specification for Stainless Steel Sheet and Strip for
Surgical Implants
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075)
F 86 Practice for Surface Preparation and Marking of Me-
tallic Surgical Implants
F 139 Specification for Wrought-18 Chromium-14 Nickel-
2.5 Molybdenum Stainless Steel Sheet and Strip for Sur-
gical Implants (UNS S31673)
2.2 American Society for Quality Control (ASQC) Stan-
dard:
FIG. 1 Preformed Cranioplasty Plate
C1-1968 Specifications of General Requirements for a
Quality Program
4.4 Thicknesses and individual shapes shall vary with need.
3. Materials Thickness tolerances shall be as follows:
Thickness Tolerances,
3.1 Cranioplasty plates conforming to this specification
Specified Thickness, in. (mm) in. (mm)
shall be fabricated from materials described in the latest issue
of Specifications F 56, Grade 2, F 75, or F 139, Grade 2. The 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)
condition of the material (such as, annealed, cold finished, and
0.020 (0.51) to 0.035 (0.89), incl 60.002 (0.05)
so forth) should be specified in the purchase order.
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 Identification
This specification is under the jurisdiction of ASTM Committee F04 on
5.1 Cranioplasty plates conforming to this specification
Medical and Surgical Materials and Devices and is the direct responsibility of
shall have their surfaces prepared in accordance with the latest
Subcommittee F04.31 on Neurosurgical Standards.
Current edition approved April 5, 1976. Published June 1976.
issue of
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