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ASTM F1829-98(2003)

Заменен
Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear — 4 стр.
Значение и использование

This test method can be used to describe the effects of materials, manufacturing, and design variables on the performance of metal backed glenoid prostheses locking mechanisms to resist static shear loading.

The glenoid component is used in shoulder replacements and should conform to the criteria specified in Specification F 1378.

The loading of metal backed glenoid prostheses in vivo will, in general, differ from the loading defined in this test method. The results obtained here can not be used to directly predict in vivo performance. However, this test method is designed to allow for comparisons between different metal backed glenoid locking mechanism designs, when tested under similar circumstances.

This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested and their potential application.

In order for the test data on metal backed glenoid components to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.

Область применения

1.1 This test method covers a method for determining the static shear disassembly force of modular glenoid components used in shoulder prostheses. It is intended to be used as a design validation and for comparison with other prostheses.

1.2 This test method covers modular glenoid components comprised of a separate articular insert and backing. The insert and backing can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials.

1.3 The values stated in SI units are regarded as the 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.

ICS
11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы
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