ASTM F452-76(1998)
(Specification)Standard Specification for Preformed Cranioplasty Plates
Standard Specification for Preformed Cranioplasty Plates
SCOPE
1.1 This specification covers preformed cranioplasty plates which do not require further alteration for covering skull defects. This specification covers compositional and physical performance and packaging requirements, but does not cover toxicity nor biocompatibility of the materials.
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Designation: F 452 – 76 (Reapproved 1998)
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 4.3 Plates shall contain multiple perforations (see Fig. 1).
1.1 This specification covers preformed cranioplasty plates
which do not require further alteration for covering skull
defects. This specification covers compositional and physical
performance and packaging requirements, but does not cover
toxicity nor biocompatibility of the materials.
2. Referenced Documents
2.1 ASTM Standards:
F 56 Specification for Stainless Steel Sheet and Strip for
Surgical Implants
F 75 Specification for Cast Cobalt-Chromium-Molybdenum
Alloy for Surgical Implant Applications
FIG. 1 Preformed Cranioplasty Plate
F 86 Practice for Surface Preparation and Marking of Me-
tallic Surgical Implants
4.4 Thicknesses and individual shapes shall vary with need.
F 139 Specification for Stainless Steel Sheet and Strip for
2 Thickness tolerances shall be as follows:
Surgical Implants (Special Quality)
Thickness Tolerances,
2.2 American Society for Quality Control (ASQC) Stan-
Specified Thickness, in. (mm) in. (mm)
dard:
C1-1968 Specifications of General Requirements for a 0.005 (0.13) to 0.010 (0.25), incl 610 %
,
3 4
0.010 (0.25) to 0.020 (0.51), incl 60.0015 (0.04)
Quality Program
0.020 (0.51) to 0.035 (0.89), incl 60.002 (0.05)
0.035 (0.89) to 0.050 (1.27), incl 60.0025 (0.06)
3. Materials
0.050 (1.27) to 0.100 (2.54), incl 60.003 (0.08)
3.1 Cranioplasty plates conforming to this specification
5. Finish and Identification
shall be fabricated from materials described in the latest issue
5.1 Cranioplasty plates conforming to this specification
of Specifications F 56, Grade 2, F 75, or F 139, Grade 2. The
shall have their surfaces prepared in accordance with the latest
condition of the material (such as, annealed, cold finished, etc.)
issue of Practice F 86. Specific requirements of surface finish
should be specified in the purchase order.
(if any) shall be stated in the purchase order.
4. Dimensions and Tolerances
5.2 The method of marking the plates shall be one of those
specified in Practice F 86.
4.1 Cranioplasty plates conforming to this specification
shall be fabricated in a variety of dimensions to accommodate,
6. Precautions
without further alteration, various sized skull defects.
6.1 Cranioplasty plates covered by this specification shall
4.2 Shape shall be contoured so as to re-establish the normal
not be reshaped in any manner after manufacture.
configuration and symmetry of the skull at various anticipated
6.2 Material used to fasten the cranioplasty plates covered
sites of defect such as the parietal bosses, the inion, the brow,
by this standard shall be the same alloy as the
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