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ASTM F622-79(2002)

(Specification)

Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)

Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)

ABSTRACT
This specification covers preformed cranioplasty plates that allow alteration of dimensions to fit a particular skull defect. Cranioplasty plates shall be manufactured from unalloyed titanium, wrought cobalt-20chromium-15tungsten-10nickel alloy, or wrought titanium-6aluminum-4vanadium extra low interstitial alloy with multiple perforations and in various dimensions, with the thickness and shape varying with need. The shape, in particular, may be altered by the neurosurgeon such as to contour it to conform to the normal configuration and symmetry of the skull at various defect sites. Should the plates require metallic sutures or screws as fasteners, they shall be of the same metallic composition as the cranioplasty plates.
SCOPE
1.1 This specification covers preformed cranioplasty plates that allow alteration for covering skull defects.
WITHDRAWN RATIONALE
This specification covers preformed cranioplasty plates that allow alteration for covering skull defects.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in January 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
29-Mar-1979
Withdrawal Date
31-Dec-2010
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
Current Stage
Ref Project

Relations

Replaces
ASTM F622-79(1998) - Standard Specification for Preformed Cranioplasty Plates that can be Altered
Effective Date
30-Mar-1979

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ASTM F622-79(2002) - Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)ASTM F622-79(2002) - Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
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ASTM F622-79(2002) - Standard Specification for Preformed Cranioplasty Plates That Can Be Altered (Withdrawn 2011)
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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: F622 – 79 (Reapproved 2002)
Standard Specification for
Preformed Cranioplasty Plates That Can Be Altered
ThisstandardisissuedunderthefixeddesignationF622;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 5. Dimensions and Tolerances
1.1 This specification covers preformed cranioplasty plates 5.1 Cranioplasty plates conforming to this specification
that allow alteration for covering skull defects. shall be fabricated in a variety of dimensions to accommodate
various sized skull defects. These plates may be altered in the
2. Referenced Documents
operating room by the neurosurgeon in order to fit a particular
2.1 ASTM Standards: skull defect.
F67 Specification for Unalloyed Titanium, for Surgical
5.2 The shape of the plate shall be contoured so as to
Implant Applications (UNS R50250, UNS R50400, UNS reestablish the normal configuration and symmetry of the skull
R50550, UNS R50700)
at various anticipated sites of defect, such as the parietal
F86 Practice for Surface Preparation and Marking of Me- bosses, the inion, the brow, the linea temporalis, and so forth.
tallic Surgical Implants
5.3 Plates shall contain multiple perforations.
F90 Specification for Wrought Cobalt-20Chromium- 5.4 Thickness and individual shapes shall vary with need.
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
Thickness tolerances shall be as follows:
tions (UNS R30605)
Specified Thickness, Tolerances,
in. (mm) in. (mm)
F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
0.020 (0.51) to 60.002 (0.05)
Implant Applications (UNS R56401)
0.035 (0.89), incl
0.035 (0.89) to 60.0025 (0.06)
2.2 ASQC Standard:
0.050 (1.27), incl
C1-1968 Specifications of General Requirements for a
0.050 (1.27) to 60.003 (0.08)
Quality Program 0.100 (2.54), incl
5.5 For plates that are cast or hand-wrought, the establish-
3. Terminology
ment of tolerances is not practical and is the responsibility of
3.1 Definition:
the implant manufacturer.
3.1.1 cranioplasty plate—an implanted prosthetic device
used to repair or cover a skull defect or hole.
6. Finish and Identification
6.1 Cranioplasty plates conforming to this specification
4. Materials
shall be finished in accordance with Practice F86.
4.1 Cranioplasty plates conforming to this specification
6.2 Cranioplasty plates conforming to this specification
shall be fabricated from one of the materials covered by the
shall be identified as to the material used for fabrication, in a
following ASTM specifications or other such materials found
manner in accordance with Practice F86.
acceptable for neurosurgical procedures only: F67, F90, and
6.3 Tantalum cranioplasty plates shall be cleaned using a
F136.
tantalum etching solution.
6.3.1 Prepare the tantalum etching solution as follows:
This specification is under the jurisdiction of ASTM Committee F04 on
Hydrofluoric acid (H F ) 48 vol % 4 parts
2 2
Medical and Surgical Materials and Devices and is the direct responsibility of Sulfuric acid (H SO ) 98 vol % 6 parts
2 4
Subcommittee F04
...

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