ISO 14242-1-2014 amd1-2018 PDF

Full title and description

ISO 14242-1:2014/Amd 1:2018 — 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 — Amendment 1. This document is an amendment to ISO 14242‑1:2014 providing clarifications and updates to the loading, displacement and environmental test parameters used in laboratory wear testing of total hip‑joint prostheses.

Abstract

This amendment refines and clarifies Part 1 of ISO 14242‑1 (2014) by updating specified angular motions, load profiles, test machine configuration options and environmental/test fluid conditions to improve repeatability and comparability of hip simulator wear tests. It is intended to be used together with the base 2014 edition of ISO 14242‑1.

General information

• Status: Published (Amendment to ISO 14242‑1:2014)
• Publication date: July 2018 (2018‑07)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics)
• Edition / version: Edition 3 of ISO 14242‑1 (2014) — Amendment 1 (2018)
• Number of pages: 3 (amendment document)

Scope

This amendment applies to ISO 14242‑1:2014 and updates the parameters and clarifications for wear‑testing machines used to evaluate total hip‑joint prostheses. The changes address detailed kinematic (angular) motions, force‑time profiles, permitted machine configurations, specimen mounting/orientation and environmental/test fluid conditions so that wear testing more closely reproduces intended test conditions and improves interlaboratory reproducibility.

Key topics and requirements

• Updated angular movement definitions for articulating components (flexion/extension, abduction/adduction, internal/external rotation) and their phasing.
• Refined axial load/time‑varying load profiles and tolerances for peak/trough values and phasing.
• Specified test frequency, run‑duration guidance and example cycle counts used for comparative wear evaluations.
• Machine configuration options and mounting/orientation guidance for acetabular and femoral components to simulate physiological loading.
• Environmental conditions and test fluid requirements (temperature control, serum composition, filtration and contamination control) for repeatable lubrication conditions.
• Apparatus performance, calibration and control specimen requirements to account for creep, fluid uptake and machine‑specific effects.

Typical use and users

Used by medical device manufacturers, independent biomechanics test laboratories, research institutions, notified bodies and regulatory reviewers to define, run and interpret hip simulator wear tests for design verification, material comparisons and preclinical performance evidence supporting regulatory submissions.

Related standards

Part of the ISO 14242 series on wear of total hip‑joint prostheses (notable related documents include ISO 14242‑2:2016 (methods of measurement), ISO 14242‑3:2009 (orbital bearing type wear testing) and related amendments and later Parts such as ISO 14242‑4). Additional related standards cover particle characterization and spinal/orthopaedic wear testing methods.

Keywords

hip prosthesis, wear testing, hip simulator, loading parameters, displacement parameters, test fluid, environmental conditions, ISO 14242, amendment 2018

FAQ

Q: What is this standard?

A: It is Amendment 1 (2018) to ISO 14242‑1:2014, which sets loading, displacement and environmental parameters for laboratory wear testing of total hip‑joint prostheses.

Q: What does it cover?

A: The amendment clarifies and updates specific test motions, load cycles, machine configurations, specimen orientation, environmental/test fluid conditions and apparatus performance tolerances used with hip simulators so wear test results are consistent and reproducible.

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, biomechanics researchers, notified bodies and regulatory reviewers use this amendment together with ISO 14242‑1:2014 for preclinical wear testing of hip joint implants.

Q: Is it current or superseded?

A: ISO 14242‑1:2014 with Amendment 1 (2018) remains the published reference for Part 1; ISO has later working documents for a future revision of Part 1, so users should check for any newer full revisions if up‑to‑date compliance is required.

Q: Is it part of a series?

A: Yes — it is part of the ISO 14242 series addressing wear of total hip‑joint prostheses (Parts 1–4 and associated amendments), which together cover test parameters, measurement methods and special test configurations.

Q: What are the key keywords?

A: Hip simulator, wear testing, loading parameters, displacement parameters, test fluid, implant wear, acetabular orientation, femoral motion, ISO 14242.