ISO 14242-1:2014 PDF

Name: ISO 14242-1:2014 — Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
SKU: ISO 14242-1:2014
Price: 25 EUR
Availability: InStock

Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

Название (английский):

ISO 14242-1:2014

Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 16 октября 2014 г.
Издание:: ISO IS 14242 edition 3 version 1
ICS:: 11.040.40

Тип поставки:

Full version150 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:2 раб. дн. (перевод)

Цена:150 €

Описание (английский):

ISO 14242-1:2014 specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration, and the test environment to be used for the wear testing of total hip-joint prostheses.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 14242-1:2014 - Implants for surgery - Wear of total hip‑joint prostheses - Part 1 defines the loading and displacement parameters and environmental conditions for laboratory wear testing of total hip‑joint prostheses. The standard specifies how hip‑simulator machines should reproduce physiological angular movements, time‑varying loads, test frequency and temperature, test fluid composition, specimen mounting and control specimens to produce reproducible, comparable wear data.

Keywords: ISO 14242-1:2014, hip-joint prostheses wear testing, wear-testing machines, loading and displacement parameters, hip simulator.

Key topics and technical requirements

Angular motion and sequencing: Three‑dimensional femoral motions (abduction/adduction, flexion/extension, internal/external rotation) with a defined sequence and phasing to reproduce physiological articulation.

Load cycle: Time‑varying axial load profile as illustrated in the standard (peak and trough values and phasing). Test machines must maintain force maxima/minima within ±3% and phasing within ±3% of cycle time.

Frequency and duration: Operation at 1 Hz ± 0.1 Hz; tests continue until a defined endpoint (including the standard upper limit of 5 million cycles or earlier in case of surface failure).

Test fluid and environment: Use of calf serum diluted with deionized water, filtered (2 µm) and protein concentration 30 g/l ± 2 g/l, stored frozen and optionally treated with antimicrobial reagent. Temperature control of the lubricant bath at 37 °C ± 2 °C and sealed enclosures to prevent contamination/evaporation.

Specimen mounting and alignment: Acetabular and femoral components mounted to reproduce intended clinical fixation and orientation (e.g., stem abduction P = 10° ± 3°, acetabular polar axis inclination L = 30° ± 3° or as manufacturer specifies).

Apparatus performance: Motion accuracy to ±3° at motion extrema and ±1% cycle time for phasing; provision for control specimens to assess creep and fluid uptake; calibration and periodic measurement schedule specified.

Applications and who uses it

Medical device manufacturers validating wear performance of hip prostheses

Test labs and biomechanics researchers operating hip simulators

Regulatory bodies and notified bodies reviewing preclinical wear evidence

Quality and verification engineers establishing test protocols for design verification

Practical uses include preclinical benchmarking of bearing materials (metal, ceramic, polymers), design comparisons, and support for regulatory submissions.

Related standards

ISO 14242-2: Methods of measurement (wear measurement procedures)

ISO 14242-3: Parameters for orbital bearing type wear testing machines

ISO 7206-1 and ISO 3696 referenced for terms/dimensions and test fluid quality

Using ISO 14242-1:2014 helps ensure reproducible, physiologically relevant wear testing and supports comparability of hip prosthesis performance data across laboratories.

ISO 14242-1:2014 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

ISO 14242-1:2014/Amd 1:2018

Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for w…

ISO 14242-2:2000

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

ISO 14242-3:2009/Amd 1:2019

Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for o…

ISO 7206-13:2016/Amd 1:2022

Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torqu…

SIST EN ISO 3696:1998

Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)