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Doplňující informace

ASTM F1264-03(2007)e1

Standard Specification and Test Methods for Intramedullary Fixation Devices (Includes all amendments And changes 12/31/2010).

Automaticky přeložený název:

Standardní specifikace a zkušební metody pro nitrodřeňové fixatérů

NORMA vydána dne 1.10.2007

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Provedení	Online zabezpečené PDF - 1 908.90 Kč Tištěné - 1 908.90 Kč
Dostupnost	SKLADEM
Cena	1908.90 Kč bez DPH
1 908.90 Kč

Informace o normě:

Označení normy: ASTM F1264-03(2007)e1
Poznámka: NEPLATNÁ
Datum vydání normy: 1.10.2007
Kód zboží: NS-49679
Počet stran: 18
Přibližná hmotnost: 54 g (0.12 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Anotace textu normy ASTM F1264-03(2007)e1 :

Keywords:

bend testing, definitions, extraction, fatigue test, fracture fixation, implants, intramedullary fixation devices, orthopaedic medical device, performance, surgical devices, terminology, test methods, torsion test, trauma, Intramedullary fixation devices (IMFDs), Mechanical performance considerations, Orthopaedic medical devices--specifications, Performance--surgical materials/applications (specifications), Skeletal system, Static tests--orthopaedic materials/applications

Doplňující informace

1. Scope

1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs) specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. It is not the intention of this specification to describe or specify specific designs for IMFDs.

1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IFMD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.

1.3 This specification includes four standard test methods:

1.3.1 Static Four-Point Bend Test Method- and

1.3.2 Static Torsion Test Method-.

1.3.3 Bending Fatigue Test Method-Annex A1.

1.3.4 Test Method for Bending Fatigue of IMFD Locking Screws-Annex A2.

1.4 A rationale is given in Appendix X1.

1.5 The values stated in SI units are to be regarded as the standard.

2. Referenced Documents

F339-71(1993)	Specification for Cloverleaf Intramedullary Pins (Withdrawn 1998)
F543-23	Standard Specification and Test Methods for Metallic Medical Bone Screws
E1823-23	Standard Terminology Relating to Fatigue and Fracture Testing
E467-21	Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
F2503-23e1	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment (Includes all amendments and changes 10/24/2023).
F1611-20	Standard Specification for Intramedullary Reamers
F565-21	Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F383	Practice for Static Bend and Torsion Testing of Intramedullary Rods
F2809-10	Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
SAE J524	Seamless Low-Carbon Steel Tubing Annealed for Bending and Flaring
AMS 5050
E467-21	Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E1823-23	Standard Terminology Relating to Fatigue and Fracture Testing
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
A214/A214M-19	Standard Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes
A450/A450M-23	Standard Specification for General Requirements for Carbon and Low Alloy Steel Tubes
D790-17	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
E4-21	Standard Practices for Force Calibration and Verification of Testing Machines
E691-23	Standard Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

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