(812) 309-78-59
(495) 223-46-76
ASTM F564-10(2015)
Standard Specification and Test Methods for Metallic Bone Staples
13 стр.
Заменен
Печатное изданиеЭлектронный (pdf)
104.52 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
ICS:
11.040.30 Surgical. Including surgical dressings, sutures, etc. / Хирургические инструменты и материалы. Включая перевязочные, шовные и другие материалы
Сборник (ASTM):
13.01 Medical and Surgical Materials and Devices (I): E667 – F2477 / Медицинские и хирургические материалы и приборы (I): E667 - F2477
Тематика:
Medical Devices & Implants
Описание
Значение и использованиеA1.3 Significance and Use

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.

Реферат

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. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.

Область применения

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 Staples—Annex A1.

1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2.

1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3.

1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex 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.

Ключевые слова:
bending test; bone fixation; fatigue test; fixation devices; metallic bone staples; orthopaedic medical devices; pullout test; soft tissue fixation; surgical implants;