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ASTM F564-10
Standard Specification and Test Methods for Metallic Bone Staples
Automaticky přeložený název:
Standardní specifikace a zkušební metody pro kovové Bone Staples
NORMA vydána dne 1.9.2010
Informace o normě:
Označení normy: ASTM F564-10
Poznámka: NEPLATNÁ
Datum vydání normy: 1.9.2010
Kód zboží: NS-55740
Počet stran: 13
Přibližná hmotnost: 39 g (0.09 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Anotace textu normy ASTM F564-10 :
Keywords:
bending test, bone fixation, fatigue test, fixation devices, metallic bone staples, orthopaedic medical devices, pullout test, soft tissue fixation, surgical implants, Bone implant materials/applications--specifications, Constant amplitude bending fatigue test, Orthopaedic medical devices--specifications, Orthopaedic medical devices (bone)--specifications, Pull-out fixation strength, Soft tissue implant materials, Staples, ICS Number Code 11.040.30 (Surgical instruments and materials)
Doplňující informace
| Significance and Use | ||||||||||||||||||
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A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances. A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories. A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application. |
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| 1. Scope | ||||||||||||||||||
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1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. 1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples: 1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone StaplesAnnex A1. 1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone StaplesAnnex A2. 1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone StaplesAnnex A3. 1.2.4 Test Method for Elastic Static Bending of Metallic Bone StaplesAnnex A4. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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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