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Zobrazovaná měna: Kč

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NEPLATNÁ ASTM F2091-01(2012) 15.1.2012 náhled

Doplňující informace

ASTM F2091-01(2012)

Standard Specification for Acetabular Prostheses

Automaticky přeložený název:

Standard Specification pro acetabula Protézy

NORMA vydána dne 15.1.2012

Jazyk
Provedení	PDF - okamžité stažení - 1 917.80 Kč Tištěné - 1 917.80 Kč
Dostupnost	SKLADEM
Cena	1917.80 Kč bez DPH
1 917.80 Kč

Informace o normě:

Označení normy: ASTM F2091-01(2012)
Poznámka: NEPLATNÁ
Datum vydání normy: 15.1.2012
Kód zboží: NS-52778
Počet stran: 6
Přibližná hmotnost: 18 g (0.04 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Anotace textu normy ASTM F2091-01(2012) :

Keywords:

acetabulum, arthroplasty, prosthesis, Orthopaedic medical devices--specifications, Surgical implants--specifications, Acetabular implant device, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Doplňující informace

1. Scope

1.1 This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur.

1.2 This specification is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined to be important to in vivo performance of the device are defined.

1.3 Acetabular prostheses included within the scope of this specification are intended for mechanical fixation between the prosthesis and host bone, by the use of bone cement or through biological fixation.

1.4 Custom (designed explicitly for a single patient), revision, or constrained acetabular prostheses are not covered within the scope of this specification.

1.5 This specification does not cover the details for quality assurance, design control, production control contained in 21 CFR 820 (Quality System Regulation) and ISO 9001.

2. Referenced Documents

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
F746-04(2021)	Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F648-21	Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F90-23	Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
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)
F562-22	Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F603-12(2020)	Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
F629-20	Standard Practice for Radiography of Cast Metallic Surgical Implants
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).
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
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).
F1185-23	Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
F1377-21	Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
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
F1714-96(2018)	Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
F1820-22	Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
F1978-22	Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
F2033-20	Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
F2565-21	Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
F2582-20	Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

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