ASTM F622-79(1998)

Standard Specification for Preformed Cranioplasty Plates that can be Altered

SCOPE
1.1 This specification covers preformed cranioplasty plates that allow alteration for covering skull defects.

General Information

• Status: Historical
• Publication Date: 31-Dec-1997
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.31 - Neurosurgical Standards

Relations

• Replaced By: ASTM F622-79(2002) - Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
• Effective Date: 30-Mar-1979

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 622 – 79 (Reapproved 1998)
Standard Specification for
Preformed Cranioplasty Plates that can be Altered
This standard is issued under the fixed designation F 622; 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 at various anticipated sites of defect, such as the parietal
bosses, the inion, the brow, the linea temporalis, etc.
1.1 This specification covers preformed cranioplasty plates
5.3 Plates shall contain multiple perforations.
that allow alteration for covering skull defects.
5.4 Thickness and individual shapes shall vary with need.
2. Referenced Documents
Thickness tolerances shall be as follows:
Specified Thickness, Tolerances,
2.1 ASTM Standards:
in. (mm) in. (mm)
F 67 Specification for Unalloyed Titanium for Surgical
Implant Applications
0.020 (0.51) to 60.002 (0.05)
0.035 (0.89), incl
F 86 Practice for Surface Preparation and Marking of Me-
0.035 (0.89) to 60.0025 (0.06)
tallic Surgical Implants
0.050 (1.27), incl
F 90 Specification for Wrought Cobalt-Chromium-
0.050 (1.27) to 60.003 (0.08)
0.100 (2.54), incl
Tungsten-Nickel Alloy for Surgical Implant Applications
F 136 Specification for Wrought Titanium 6A1-4V ELI
5.5 For plates that are cast or hand-wrought, the establish-
Alloy for Surgical Implant Applications
ment of tolerances is not practical and is the responsibility of
2.2 ASQC Standard:
the implant manufacturer.
C1-1968 Specifications of General Requirements for a
6. Finish and Identification
Quality Program
6.1 Cranioplasty plates conforming to this specification
3. Terminology
shall be finished in accordance with Practice F 86.
3.1 Definition:
6.2 Cranioplasty plates conforming to this specification
3.1.1 cranioplasty plate—an implanted prosthetic device
shall be identified as to the material used for fabrication, in a
used to repair or cover a skull defect or hole.
manner in accordance with Practice F 86.
6.3 Tantalum cranioplasty plates shall be cleaned using a
4. Materials
tantalum etching solution.
4.1 Cranioplasty plates conforming to this specification
6.3.1 Prepare the tantalum etching solution as follows:
shall be fabricated from one of the materials covered by the
Hydrofluoric acid (H F ) 48 vol % 4 parts
2 2
following ASTM specifications or other such materials found Sulfuric acid (H SO ) 98 vol % 6 parts
2 4
Nitric acid (HNO ) 70 vol % 3 parts
acceptable for neurosurgical procedures only: F 67, F 90, and
Water 13 parts
F 136.
6.3.2 Use the tantalum etching solution at room temperature
5. Dimensions and Tolerances
for a period of 15 min (Note 1). Wash with water immediately.
5.1 Cranioplasty plates conforming to this specification
NOTE 1—The 15-min dip followed by a water bath is necessary to clean
shall be fabricated in a variety of dimensions to accommodate
the tantalum cranioplasty plates.
various sized skull defects. These plates may be altered in the
6.3.3 Warning—The use o
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