ISO 14242-3:2009 PDF

Name: ISO 14242-3:2009 — Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
SKU: ISO 14242-3:2009
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Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test

Название (английский):

ISO 14242-3:2009

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 9 марта 2009 г.
Издание:: ISO IS 14242 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

ISO 14242-3:2009 specifies relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the orbital bearing type wear testing of total hip joint prostheses.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 14242-3:2009 specifies the loading, displacement and environmental parameters for orbital bearing type wear testing machines used to simulate wear of total hip‑joint prostheses (THA). It defines how to position components, the time‑dependent force cycle, angular motions, test frequency, test medium and temperature, and general test‑station requirements so that results from orbital bearing hip simulators (OBM) are reproducible and comparable between laboratories.

Key Topics and Requirements

Scope: Relative angular movement between articulating components, applied force pattern, speed/duration, sample configuration and test environment for OBM hip wear testing.

Motion and phasing: Angular movements for flexion/extension and abduction/adduction follow a defined cycle (e.g., ±23° peaks) with motion accuracy of ±3° at maxima/minima and phasing accuracy of ±1% of cycle time.

Loading profile: Time‑dependent axial force cycle (example values from the standard): 0.3 kN → 3.0 kN → 1.5 kN → 3.0 kN → 0.3 kN across the gait cycle; force control tolerance ±3% of maximum (figure notes ±90 N) and phasing ±1% of cycle time.

Frequency: Operate at 1 Hz ± 0.1 Hz.

Specimen mounting & orientation: Requirements for reproducible alignment of femoral and acetabular components (e.g., polar axis and inclination L = 30° ± 3° or L = (75 − N)° ± 3° when using manufacturer‑specified implantation angle N; stem abduction position P = 10° ± 3°).

Test medium & environment: Fluid medium typically calf serum diluted to ~25% by volume, filtered to 2 µm and protein concentration ≥17 g/L. Maintain 37 °C ± 2 °C, immersion lubrication (minimum 200 ml), sealed enclosures to prevent contamination.

Apparatus & controls: Machine capabilities for motion control, force control, alignment, enclosure, temperature control and calibration (calibrate each station with a load cell). Include control specimens to assess creep/fluid uptake.

Documentation: Test report and specimen handling/disposal procedures per clauses in the standard.

Applications and Users

ISO 14242-3 is intended for:

Orthopaedic implant manufacturers validating wear performance of hip components

Independent biomechanical test laboratories and academic researchers performing comparative wear studies

Regulatory submissions and pre‑clinical testing where standardized simulator data are required

R&D teams assessing new bearing materials (polyethylene, metal, ceramic) and crosslinked polyethylenes

Using this ISO protocol helps predict in‑vivo wear trends, supports product development, and ensures consistent, auditable wear test data.

Related Standards

ISO 14242‑1 - Loading and displacement parameters for wear‑testing machines (general)

ISO 14242‑2 - Methods of measurement (wear measurement and specimen handling)

Keywords: ISO 14242-3:2009, orbital bearing machine, hip wear testing, total hip arthroplasty, THA wear simulator, hip prosthesis testing, calibration, serum lubricant.

ISO 14242-3:2009 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Applications and Users

Related Standards

Технические детали

ISO 14242-3:2009/Amd 1:2019

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ISO 14242-1:2014/Amd 1:2018

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ISO 14242-2:2000

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