ASTM F452-76(2022)

Standard Specification for Preformed Cranioplasty Plates

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STANDARD published on 1.11.2022

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The information about the standard:

Designation standards: ASTM F452-76(2022)
Publication date standards: 1.11.2022
SKU: NS-1088773
The number of pages: 2
Approximate weight : 6 g (0.01 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F452-76(2022) :

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.

Keywords:

bone plates, cranioplasty plates, neurosurgical medical devices/applications, orthopaedic medical devices,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

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.

1.2?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F139-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
ASQ C1	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.
F86-21(2026)	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F56-82	Specification for Stainless Steel Sheet and Strip for Surgical Implants (Withdrawn 1989)

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