ISO 14242-3-2009 amd1-2019 PDF

Full title and description

ISO 14242-3:2009/Amd 1:2019 — 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 — Amendment 1. This amendment modifies and/or clarifies selected loading, displacement and environmental test parameters that apply to orbital bearing‑type wear testing of total hip‑joint prostheses, and is intended to be used together with ISO 14242‑3:2009.

Abstract

This document is Amendment 1 (2019) to ISO 14242‑3:2009. It provides changes and/or additions to the original Part 3 text concerning the prescribed loading and displacement patterns for orbital bearing‑type wear test machines and the corresponding environmental conditions (for example test fluid and temperature) that should be used when performing wear testing of total hip‑joint prostheses. The amendment is short (4 pages) and applies directly to ISO 14242‑3:2009.

General information

• Status: Published (Amendment to ISO 14242‑3:2009).
• Publication date: January 2019 (effective/valid from 10 January 2019).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: Amendment 1, Edition 1 (2019).
• Number of pages: 4.

Scope

This amendment applies to ISO 14242‑3:2009 and updates specific parameters used for orbital bearing‑type wear testing machines — including prescribed loading/displacement patterns and the environmental/test conditions to be used during wear trials of total hip‑joint prostheses. It is intended to be read and applied in conjunction with the base ISO 14242 series documents that define test methods and measurement procedures for hip prosthesis wear testing.

Key topics and requirements

• Amendment to the loading and displacement parameters for orbital bearing‑type wear testers (clarifications and/or numerical adjustments where specified).
• Specification or clarification of corresponding environmental test conditions (for example test fluid, temperature and other relevant conditions affecting wear test reproducibility).
• Normative linkage to ISO 14242‑3:2009 (i.e., the amendment modifies the Part 3 document rather than replacing it).
• Intended use with other parts of the ISO 14242 series (parts that define overall loading/displacement parameters and measurement methods).

Typical use and users

Test laboratories performing hip prosthesis wear testing, orthopedic implant manufacturers (design and verification teams), regulatory bodies and notified bodies reviewing pre‑market test evidence, and academic or industrial researchers studying hip implant wear and tribological performance. The amendment is used when the orbital bearing‑type test method (Part 3) is selected for wear evaluation or comparison.

Related standards

Key related documents in the ISO 14242 series and adjacent areas include ISO 14242‑1 (loading and displacement parameters for wear‑testing machines), ISO 14242‑2 (methods of measurement for wear), ISO 14242‑4 (edge‑loading test conditions), and the original ISO 14242‑3:2009 (to which this amendment applies). These documents are normally used together to specify test configuration, execution and measurement for hip prosthesis wear studies.

Keywords

hip prosthesis, hip joint, wear testing, orbital bearing, loading parameters, displacement parameters, test environment, amendment 2019, ISO 14242‑3.

FAQ

Q: What is this standard?

A: ISO 14242‑3:2009/Amd 1:2019 is Amendment 1 (2019) to Part 3 of the ISO 14242 series (wear of total hip‑joint prostheses) and modifies the Part 3 document that covers orbital bearing‑type wear testing machines.

Q: What does it cover?

A: It covers changes and clarifications to the loading and displacement parameters and the corresponding environmental/test conditions for orbital bearing‑type wear testing of total hip‑joint prostheses (used together with ISO 14242‑3:2009). The amendment itself is concise (4 pages) and is applied as an update to the Part 3 text.

Q: Who typically uses it?

A: Accredited wear test laboratories, hip implant manufacturers (design/verification), regulatory reviewers and researchers conducting or assessing orbital bearing‑type wear tests for hip prostheses.

Q: Is it current or superseded?

A: This document is an amendment published in January 2019 and remains an amendment to ISO 14242‑3:2009. The base Part 3 standard and the broader ISO 14242 series have undergone periodic review; users should confirm the current status of the base standard and any later amendments or revisions via ISO or their national standards body before relying on a specific test procedure.

Q: Is it part of a series?

A: Yes — it is part of the ISO 14242 series (Parts 1–4) that together define loading/displacement parameters, measurement methods and special test conditions for wear testing of total hip‑joint prostheses.

Q: What are the key keywords?

A: Hip prosthesis wear testing; orbital bearing type; loading and displacement parameters; test environment; ISO 14242‑3 amendment; implant testing.