ISO 14243-5-2019 PDF

Full title and description

ISO 14243-5:2019 — Implants for surgery — Wear of total knee prostheses — Part 5: Durability performance of the patellofemoral joint. This International Standard specifies test motions, loads, specimen configuration and environmental conditions for durability testing of the patellofemoral (patella–femoral) articulation of total knee prostheses in laboratory wear-testing machines.

Abstract

This document defines the relative angular movement between articulating patellofemoral components, the pattern of applied force, test speeds and durations, specimen configurations and the test environment to be used for durability testing of total knee‑joint prostheses in wear‑testing machines operating in load or displacement control. It is intended to provide repeatable, reproducible preclinical durability assessment of the patellofemoral articulation.

General information

• Status: Published (International Standard; reviewed/confirmed in subsequent ISO review cycle).
• Publication date: May 2019 (edition 1, published 2019-05-23).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: Edition 1 (2019).
• Number of pages: 16 pages.

Scope

Specifies a laboratory durability test method for the patellofemoral joint of total knee prostheses: required kinematic waveforms (flexion/extension and relative angular motion of patella to femur), axial/compressive loading patterns, cycle sequencing (including squat and low‑flexion subcycles), specimen mounting and preparation, environmental/test fluid conditions, test duration/cycle limits and reporting requirements. The standard is intended for preclinical durability evaluation (failure mode identification and comparative assessment) rather than clinical performance prediction.

Key topics and requirements

• Test principle: cyclic waveforms combining a high‑flexion (squat) subcycle and low‑flexion subcycles to reproduce patellofemoral kinematics until failure or a specified cycle limit.
• Loading and timing: defined flexion ranges, compressive load magnitudes (expressed relative to body weight), and subcycle frequencies/total cycle time to ensure repeatable loading.
• Specimen selection and preparation: recommendations for worst‑case geometries, number of specimens, rigid mounting (cement or rigid fixation), and optional artificial ageing/preconditioning where applicable.
• Apparatus and instrumentation: requirements for wear‑testing machines able to reproduce the specified displacements/loads, fixtures to measure mediolateral forces and torques, and guidelines for data capture and calibration.
• Test environment and fluids: use of specified test serum/solution, temperature control and optional additives; measures to minimise biological degradation and contamination.
• End points and reporting: cycle limit and stop criteria (including failure definitions), required data to report (test conditions, specimens, results, observations), and guidance for interpreting durability outcomes.

Typical use and users

Used by orthopaedic implant manufacturers, independent wear‑test laboratories, research groups, regulatory bodies and conformity assessment/Notified Bodies for preclinical durability testing, design verification and comparative evaluation of patellofemoral components of total knee systems. It is also referenced in regulatory recognition lists for device evaluation.

Related standards

ISO 14243‑5:2019 is part of the ISO 14243 series on wear of total knee prostheses. Closely related items include: ISO 14243‑1 (loading and displacement parameters for wear‑testing machines with load control), ISO 14243‑2 (methods of measurement — gravimetric wear assessment), and ISO 14243‑3 (loading and displacement parameters for displacement control machines). These documents together define test inputs, measurement methods and environmental conditions used for tibiofemoral and patellofemoral wear testing.

Keywords

total knee prosthesis, patellofemoral joint, wear testing, durability, simulator, load control, displacement control, cycle parameters, preclinical testing, ISO/TC 150/SC 4.

FAQ

Q: What is this standard?

A: ISO 14243‑5:2019 is an ISO International Standard that specifies durability (fatigue/wear) test conditions and procedures for the patellofemoral articulation of total knee prostheses used in laboratory wear‑testing machines.

Q: What does it cover?

A: It covers required kinematics (relative angular motions), load waveforms, cycle sequencing (squat and low‑flexion subcycles), specimen mounting/preparation, environmental/test fluid conditions, apparatus requirements and reporting for durability testing of patellofemoral components. It is focused on reproducible preclinical durability assessment.

Q: Who typically uses it?

A: Implant manufacturers, independent testing laboratories, academic researchers, regulatory reviewers and conformity assessment bodies use this standard for verification, comparative testing and regulatory submissions. The standard appears on recognised‑standards lists used by regulators.

Q: Is it current or superseded?

A: ISO 14243‑5:2019 is the first published edition (2019). The ISO catalogue indicates the publication and subsequent ISO review/confirmation status; users should check their national standards body or ISO catalogue for any later confirmations, amendments or revisions.

Q: Is it part of a series?

A: Yes — it is part of the ISO 14243 series (parts 1–5) that together address wear testing of total knee prostheses (input parameters, measurement methods and patellofemoral/tibiofemoral procedures). Use together with ISO 14243‑1, ‑2 and ‑3 as appropriate.

Q: What are the key keywords?

A: Patellofemoral joint, knee prosthesis, wear testing, durability, simulator, load waveform, cycle parameters, preclinical evaluation, ISO 14243.