ASTM F452-76(2014)

Standard Specification for Preformed Cranioplasty Plates

ABSTRACT
This specification covers compositional, physical performance, and packaging requirements of preformed cranioplasty plates for covering skull defects. This specification does not cover toxicity nor biocompatibility of the material. Cranioplasty shall be fabricated in a variety of dimensions to accommodate various sized skull defects and shall contain multiple perforations. Cranioplasty plates shall conform to materials, manufacturing, packaging, and labeling requirements of this specification.
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2014
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F452 −76 (Reapproved 2014)
Standard Specification for
Preformed Cranioplasty Plates
ThisstandardisissuedunderthefixeddesignationF452;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 4. Dimensions and Tolerances
4.1 Cranioplasty plates conforming to this specification
1.1 This specification covers preformed cranioplasty plates
shall be fabricated in a variety of dimensions to accommodate,
which do not require further alteration for covering skull
without further alteration, various sized skull defects.
defects. This specification covers compositional and physical
performance and packaging requirements, but does not cover
4.2 Shape shall be contoured so as to re-establish the normal
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).
F56 Specification for Stainless Steel Sheet and Strip for
4.4 Thicknesses and individual shapes shall vary with need.
Surgical Implants (Withdrawn 1989)
Thickness tolerances shall be as follows:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
Thickness Tolerances,
Alloy Castings and Casting Alloy for Surgical Implants
Specified Thickness, in. (mm) in. (mm)
(UNS R30075)
0.005 (0.13) to 0.010 (0.25), incl ±10 %
F86 Practice for Surface Preparation and Marking of Metal-
0.010 (0.25) to 0.020 (0.51), incl ±0.0015 (0.04)
lic Surgical Implants
0.020 (0.51) to 0.035 (0.89), incl ±0.002 (0.05)
F139 Specification for Wrought 18Chromium-14Nickel-
0.035 (0.89) to 0.050 (1.27), incl ±0.0025 (0.06)
0.050 (1.27) to 0.100 (2.54), incl ±0.003 (0.08)
2.5Molybdenum Stainless Steel Sheet and Strip for Sur-
gical Implants (UNS S31673)
5. Finish and Identification
2.2 American Society for Quality (ASQ) Standard:
5.1 Cranioplasty plates conforming to this specification
ASQ C1 Specifications of General Requirements for a Qual-
shall have their surfaces prepared in accordance with the latest
ity Program
issueofPracticeF86.Specificrequirementsofsurfacefinish(if
any) shall be stated in the purchase order.
3. Materials
5.2 The method of marking the plates shall be one of those
3.1 Cranioplasty plates conforming to this specification
specified in Practice F86.
shall be fabricated from materials described in the latest issue
of Specifications F56, Grade 2, F75,or F139, Grade 2. The
6. Precautions
condition of the material (such as, annealed, cold finished, and
6.1 Cranioplasty plates covered by this specification shall
so forth) should be specified in the purchase order.
not be reshaped in any manner after manufacture.
6.2 Material used to fasten the cranioplasty plates covered
bythisspecificationshallbethesamealloyasthematerialused
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
to
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F452 − 76 (Reapproved 2008) F452 − 76 (Reapproved 2014)
Standard Specification for
Preformed Cranioplasty Plates
This standard is issued under the fixed designation F452; 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 (´) indicates an editorial change since the last revision or reapproval.
1. 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.
2. Referenced Documents
2.1 ASTM Standards:
F56 Specification for Stainless Steel Sheet and Strip for Surgical Implants (Withdrawn 1989)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F139 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants
(UNS S31673)
2.2 American Society for Quality (ASQ) Standard:
ASQ C1 Specifications of General Requirements for a Quality Program
3. Materials
3.1 Cranioplasty plates conforming to this specification shall be fabricated from materials described in the latest issue of
Specifications F56, Grade 2, F75, or F139, Grade 2. The condition of the material (such as, annealed, cold finished, and so forth)
should be specified in the purchase order.
4. Dimensions and Tolerances
4.1 Cranioplasty plates conforming to this specification shall 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 normal configuration and symmetry of the skull at various anticipated sites
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:
Thickness Tolerances,
Specified Thickness, in. (mm) in. (mm)
0.005 (0.13) to 0.010 (0.25), incl ±10 %
0.010 (0.25) to 0.020 (0.51), incl ±0.0015 (0.04)
0.020 (0.51) to 0.035 (0.89), incl ±0.002 (0.05)
0.035 (0.89) to 0.050 (1.27), incl ±0.0025 (0.06)
0.050 (1.27) to 0.100 (2.54), incl ±0.003 (0.08)
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.31 on Neurosurgical Standards.
Current edition approved Feb. 1, 2008Oct. 1, 2014. Published March 2008November 2014. Originally approved in 1976. Last previous edition approved in 20022008 as
F452 – 76 (2002).(2008). DOI: 10.1520/F0452-76R08.10.1520/F0452-76R14.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
The last approved version of this historical standard is referenced on www.astm.or
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