ISO 18192-1:2011 PDF

Name: ISO 18192-1:2011 — Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
SKU: ISO 18192-1:2011
Price: 25 EUR
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Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test

Название (английский):

ISO 18192-1:2011

Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 26
Дата публикации:: 25 февраля 2011 г.
Издание:: ISO IS 18192 edition 2 version 1
ICS:: 11.040.40

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Описание (английский):

ISO 18192-1:2011 defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses. Both lumbar and cervical prostheses are addressed.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 18192-1:2011 - Implants for surgery: Wear of total intervertebral spinal disc prostheses - Part 1 defines standardized wear testing methods for total intervertebral disc prostheses (both lumbar and cervical). The standard specifies loading and displacement parameters, test frequency, sample configuration, environmental conditions and reporting requirements to evaluate articulating component wear under controlled laboratory conditions.

Key topics and technical requirements

Scope and purpose: Establishes a repeatable wear test for relative angular movement between articulating components of total disc replacements (not for partial devices such as nucleus replacements).

Angular displacements: Provides specific ranges for cervical and lumbar motion (e.g., cervical flexion/extension up to ±7.5°, axial rotation ~±4°, lateral bending ~±6°; lumbar motions are smaller and specified in the standard).

Load profiles: Defines cyclic axial loads (typical ranges: cervical ~50–150 N; lumbar ~600–2 000 N) with a sinusoidal load curve and specified phasing between motions.

Frequency and cycle limit: Tests run at (1 ± 0.1) Hz. The standard introduces the term “cycle limit” - the number of cycles at which tests are terminated if no functional failure occurs; users may justify alternative cycle limits.

Shear loading: Lumbar implants are inclined (10° in the sagittal plane) to generate defined shear forces; users may intensify shear or alter loading to evaluate design sensitivity.

Test environment: Fluid test medium is calf serum diluted to 20 g ± 2 g protein/L, temperature maintained at 37 ± 2 °C, with options to filter and add antimicrobial agents or EDTA (if justified).

Specimens and controls: Recommended minimum of six specimens for wear testing plus at least one load-soak control to correct for fluid uptake when polymers are tested.

Apparatus tolerances: Motion accuracy ±0.5° at extremes, phasing tolerance ±2% of cycle time; force magnitude ±5% and phasing ±3% of cycle time.

Limitations: The method does not reproduce full in vivo complexity; wear results are comparative and may differ from clinical performance.

Applications and users

ISO 18192-1 is essential for:

Spinal implant manufacturers (design verification and pre-clinical wear characterization)

Biomechanical test laboratories (standardized test execution and reporting)

Regulatory bodies and notified bodies (evidence for device approval)

R&D teams and contract testing services assessing material pairs, design changes or longevity

Quality assurance for comparability between implant designs

This standard supports risk assessment, design validation and regulatory submissions by providing reproducible wear data.

ISO 18192-1:2011 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ASTM STP153520120004

Comparison of Daily Motion of the Cervical and Lumbar Spine to ASTM F2423-11 and ISO 18192-1.2011 Standard Te…

BS ISO 18192-2:2010

Implants for surgery. Wear of total intervertebral spinal disc prostheses. Nucleus replacements.

ISO 14242-2:2000

Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement