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ASTM F543-13
Standard Specification and Test Methods for Metallic Medical Bone Screws
Automaticky preložený názov:
Štandardné špecifikácie a testovacie metódy pre kovové Medical kostných skrutiek
NORMA vydaná dňa 1.5.2013
Informácie o norme:
Označenie normy: ASTM F543-13
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.5.2013
Kód tovaru: NS-55666
Počet strán: 19
Približná hmotnosť: 57 g (0.13 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Anotácia textu normy ASTM F543-13 :
Keywords:
bone screw, dimensions, insertion, performance requirements, pullout, static, test methods, torsion, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Doplňujúce informácie
| Significance and Use | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| A1.1. Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products. |
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| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification. 1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included: 1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws. 1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws. 1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws. 1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws. 1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws. 1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws. 1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections. 1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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