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ASTM F2009-00(2011)

Заменен
Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses — 4 стр.
Значение и использование

This test method helps to assess the axial locking force of a modular taper. Examples of these devices are described in Specification . Some types of devices that may utilize this type of connection are the modular shoulder and modular hip prostheses. Additional means of evaluating the locking mechanisms of tapers may be appropriate, depending upon the design of the device.

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

While this test method may be used to measure the force required to disengage tapers, any comparison of such data for various component designs must take into consideration the size of the implant and the type of locking mechanism evaluated.

Область применения

1.1 This test method establishes a standard methodology for determining the force required, under laboratory conditions, to disassemble tapers of implants that are otherwise not intended to release. Some examples are the femoral components of a total or partial hip replacement or shoulder in which the head and base component are secured together by a self-locking taper.

1.2 This test method has been developed primarily for evaluation of metal and ceramic head designs on metal tapers but may have application to other materials and designs.

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.

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