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Standard Specification for Resurfacing Patellar Prosthesis
Automaticky přeložený název:
Standardní specifikace pro resurfacing pately protézy
NORMA vydána dne 1.4.2014
Označení normy: ASTM F1672-14
Poznámka: NEPLATNÁ
Datum vydání normy: 1.4.2014
Kód zboží: NS-51117
Počet stran: 5
Přibližná hmotnost: 15 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
arthroplasty, patella, prosthesis, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||||||||||||||||||||||||||||||||||||||||||||
1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur. 1.2 This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined. 1.3 This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001.
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Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
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Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
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Standard Specification for Acrylic Bone Cement
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Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
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Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
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Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).
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Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).
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Standard Practice for Permanent Marking of Orthopaedic Implant Components
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Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
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ISO 9001
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Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
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Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings (Includes all amendments and changes 1/19/2018).
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Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
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Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
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Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
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Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
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Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
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Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
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