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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F56 Specification for Stainless Steel Sheet and Strip for Surgical Implants
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)
American Society for Quality (ASQ) Standard
ASQC1 Specifications of General Requirements for a Quality Program Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
cranioplasty plates; neurosurgical medical devices/applications; orthopaedic medical devices; bone plates; Cranioplasty plates; Neurosurgical medical devices/applications--specifications; Orthopaedic medical devices (bone)--specifications; Orthopaedic medical devices (bone plates);
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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