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Zobrazovaná měna: Kč

Zobrazení ceny: bez DPH

Doplňující informace

ASTM F2083-12

Standard Specification for Knee Replacement Prosthesis

Automaticky přeložený název:

Standardní specifikace pro Knee Replacement protézy

NORMA vydána dne 1.11.2012

Jazyk
Provedení	PDF - okamžité stažení - 2 010.10 Kč Tištěné - 2 010.10 Kč
Dostupnost	SKLADEM
Cena	2010.10 Kč bez DPH
2 010.10 Kč

Informace o normě:

Označení normy: ASTM F2083-12
Poznámka: NEPLATNÁ
Datum vydání normy: 1.11.2012
Kód zboží: NS-52736
Počet stran: 9
Přibližná hmotnost: 27 g (0.06 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Implantáty pro chirurgii, protetiku a ortotiku

Anotace textu normy ASTM F2083-12 :

Keywords:

arthroplasty, contact area, contact pressure, fatigue, knee, knee constraint, knee prosthesis, knee wear, particles, surface roughness, total knee replacement, TKR, unicondylar knee replacement (UKR), UHMWPE, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Doplňující informace

1. Scope

1.1 This specification is intended to cover all the widely used generic types of knee replacement prostheses used to provide functioning articulation. This includes total knee replacement (TKR) and unicondylar knee replacement (UKR) prostheses of both fixed and mobile bearing varieties, and for primary or revision surgeries. Although a patellar component may be considered an integral part of a TKR, the detailed description of this component is excluded here since it is provided in Specification F1672.

1.2 Included within the scope of this specification are replaceable components of modular designs, for example, tibial articulating surfaces and all components labeled for, or capable of, being used with cement, regardless of whether the same components can also be used without cement.

1.3 This specification is intended to provide basic descriptions of material and prosthesis geometry. Additionally, those characteristics determined to be important to 1.4 Excluded from the scope are hemiarthroplasty devices that replace only the femoral or tibial surface, but not both; and patellofemoral prostheses. Also excluded are devices designed for custom applications.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

2. Referenced Documents

F2777-23	Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
F90-23	Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
F745-07	Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)
F1044-05(2017)e1	Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).
F1108-21	Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147-05(2017)e1	Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).
F1160-14(2017)e1	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).
F1472-23	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537-20	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
F1580-18	Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
F1800-19e1	Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements (Includes all amendments and changes 1/17/2020).
F2384-10(2016)	Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)
F732-17	Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
F746-04(2021)	Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799-19	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F983-86(2018)	Standard Practice for Permanent Marking of Orthopaedic Implant Components
F1223-20	Standard Test Method for Determination of Total Knee Replacement Constraint
F1377-21	Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
F1672-14	Standard Specification for Resurfacing Patellar Prosthesis
F1814-22	Standard Guide for Evaluating Modular Hip and Knee Joint Components
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F136-13(2021)e1	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).
F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F451-21	Standard Specification for Acrylic Bone Cement
F562-22	Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F563-00	Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F2722-21	Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
F2723-21	Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F2724-21	Standard Test Method for Evaluating Mobile Bearing Knee Dislocation