ISO/TS 13498:2011 PDF

Name: ISO/TS 13498:2011 — Dentistry — Torsion test of implant body/connecting part joints of endosseous dental implant systems
SKU: ISO/TS 13498:2011
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Dentistry — Torsion test of implant body/connecting part joints of endosseous dental implant systems

Название (английский):

ISO/TS 13498:2011

Dentistry — Torsion test of implant body/connecting part joints of endosseous dental implant systems

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 21 июля 2011 г.
Издание:: ISO TS 13498 edition 1 version 1
ICS:: 11.060.15

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Описание (английский):

ISO/TS 13498:2011 establishes a method to determine the torsional yield strength and maximum torque of the implant body/connecting part joints of endosseous dental implant systems. This test is most appropriate for evaluating new types of joints and connecting parts, as well as new materials. ISO/TS 13498:2011 provides a protocol for torsional loading of an implant body/connecting part joint. It is not applicable for predicting the in vivo performance of an endosseous dental implant system and it is not derived from observations of clinical failure.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO/TS 13498:2011 - Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems defines a standardized laboratory method to measure the torsional yield strength and maximum torque of the joint between an endosseous implant body and its connecting part. The Technical Specification is intended for comparative evaluation of new joint designs, connection geometries and materials. It is explicitly not intended to predict in vivo clinical performance or to be derived from clinical failure data.

Key topics and requirements

Test objective: Determine torsional yield strength (2° offset method) and maximum torque from a torque vs. rotation angle curve.

Specimen preparation: Test finished devices or equivalent specimens that underwent the same manufacturing and sterilization process; connecting part secured with the manufacturer’s specified screw and tightening torque.

Clamping: Implant body and connecting part shall each be held at a maximum of 5 mm from the interface in specimen holders.

Testing device components: specimen holders, torque transducer, torsional driving device and torsional displacement transducer (central axes coincident).

Instrumentation limits: torque transducer range shall not exceed 5× the anticipated minimum torsional yield strength; maximum inaccuracy ±1% of the maximum torque.

Test conditions & procedure: room temperature 20 ±5 °C in air; apply continuous torque at 1 to 10 degrees per minute and record torque vs. rotation angle; perform tests on at least six specimens.

Data evaluation: torsional yield strength determined by the 2° offset method; maximum torque is the largest recorded torque. Observe deformed/fractured regions under low-magnification microscopy.

Test report content: identification of specimens (connection type, manufacturer, materials, dimensions), test method and conditions, measured torsional yield strength and maximum torque, microscopic observations, and reference to ISO/TS 13498:2011.

Practical applications and users

ISO/TS 13498:2011 is useful for:

Dental implant manufacturers developing new connection designs (internal/external anti-rotation, taper-fit, hexagonal, etc.).

R&D and mechanical testing laboratories performing comparative strength assessments and design validation.

Quality assurance teams verifying production batches for mechanical integrity of joints.

Materials suppliers evaluating new alloys or surface treatments for connecting components.

Regulatory or conformity assessment bodies seeking standardized test data for technical files (while noting the spec does not predict clinical outcomes).

Related standards

ISO 1942 (Dentistry - Vocabulary) - referenced terminology.

Bibliographic references include ISO 898-7 (mechanical properties of fasteners) and ASTM F543 (medical bone screws) for related test concepts and context.

Keywords: ISO/TS 13498:2011, torsion test, dental implants, torsional yield strength, maximum torque, implant body/connecting part joints, endosseous dental implant systems.

ISO/TS 13498:2011 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications and users

Related standards

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