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Standard Specification for Preformed Cranioplasty Plates
Přeložit název
NORMA vydána dne 1.11.2022
Označení normy: ASTM F452-76(2022)
Datum vydání normy: 1.11.2022
Kód zboží: NS-1088773
Počet stran: 2
Přibližná hmotnost: 6 g (0.01 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
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)
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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. |
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| 2. Referenced Documents | ||||||||||
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