ISO 7207-2:2011/Amd 2:2020
(Amendment)Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials - Amendment 2
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials - Amendment 2
Implants chirurgicaux — Éléments de prothèses partielle et totale de l'articulation du genou — Partie 2: Surfaces articulaires constituées de matériaux métalliques, céramiques et plastiques — Amendement 2
General Information
- Status
- Published
- Publication Date
- 23-Jun-2020
- Technical Committee
- ISO/TC 150/SC 4 - Bone and joint replacements
- Drafting Committee
- ISO/TC 150/SC 4/WG 1 - Mechanical testing
- Current Stage
- 9599 - Withdrawal of International Standard
- Start Date
- 07-Aug-2025
- Completion Date
- 13-Dec-2025
Relations
- Effective Date
- 08-May-2020
- Effective Date
- 01-Oct-2022
Overview
ISO 7207-2:2011/Amd 2:2020 is a key international standard that specifies requirements for the articulating surfaces of components used in partial and total knee joint prostheses. This amendment updates material and measurement criteria for surfaces made of metal, ceramic, and plastics to enhance the performance, durability, and safety of knee implants used in surgical procedures.
Issued by ISO, the global organization for standardization, this document covers precise surface roughness measurement methods to ensure optimal articulation and longevity of knee joint prosthetic components. It focuses on femoral, tibial, and patellar elements of various knee prosthesis designs, including unicompartmental, bicompartmental, and tricompartmental implants.
Key Topics
Surface Material Requirements
Components’ articulating surfaces must be manufactured from medically appropriate metals, ceramics, or plastics to ensure biocompatibility, wear resistance, and mechanical strength.Surface Roughness Measurement (Ra Value)
Surface roughness is critical for implant performance. The amendment defines measurement protocols aligned with ISO 4288:- Metallic and ceramic femoral elements require a maximum Ra ≤ 0.1 µm with a cutoff length of 0.25 mm.
- Tibial metallic and ceramic surfaces also must have Ra ≤ 0.1 µm.
- Plastic tibial and patellar components require a maximum Ra ≤ 2 µm with a cutoff of 0.8 mm.
Measurement Points Based on Prosthesis Type
- For bicompartimental or tricompartmental knee prostheses, roughness is measured at multiple points corresponding to contact zones at various flexion degrees (0°, 30°, 60°).
- Unicompartmental prostheses require fewer measurement points focused on the active articulation areas.
- Rotulian (patellar) surface roughness measurements are standardized at three equally spaced points.
Directional Measurement Protocols
Roughness measurements on plastics are performed perpendicular to machining marks to accurately reflect surface conditions.
Applications
Knee Joint Replacement Surgery
The standard ensures that partial and total knee joint prostheses components meet stringent quality and performance criteria to reduce wear, improve longevity, and enhance patient outcomes.Prosthesis Design and Manufacturing
Manufacturers use these specifications to optimize materials and surface finishing processes for femoral, tibial, and patellar components, ensuring compatibility and proper articulation.Quality Control and Compliance Testing
Medical device companies and testing labs adopt the standard’s detailed surface roughness measurement methods during product development, verification, and certification to meet regulatory requirements.Research and Development
Biomedical researchers reference ISO 7207-2 amendments to establish baseline criteria for novel biomaterials and surface treatments aimed at improving knee implant performance.
Related Standards
ISO 4288: Surface Texture – Profile Method
Provides the measurement methodology for surface roughness referenced in ISO 7207-2 amendments.ISO 7207-1: Implants for Surgery – Knee Prostheses – Part 1: Classification and Terminology
Defines terminology and classifications pertinent to knee joint prostheses, complementing Part 2’s focus on surfaces.ISO 13485: Medical Devices – Quality Management Systems
Ensures organizations manufacturing knee implants maintain quality standards consistent with ISO 7207-2 requirements.ISO 10993 Series: Biological Evaluation of Medical Devices
Addresses biocompatibility of implant materials such as metals, ceramics, and plastics used in knee prostheses.
Keywords: ISO 7207-2 amendment 2, knee joint prostheses, knee implant standards, articulating surfaces, surface roughness Ra, metal knee implant, ceramic knee component, plastic prosthesis materials, surgical implants, prosthetic surface measurement, implant manufacturing standards.
ISO 7207-2:2011/Amd 2:2020 - Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials — Amendment 2 Released:6/24/2020
ISO 7207-2:2011/Amd 2:2020 - Implants chirurgicaux — Éléments de prothèses partielle et totale de l'articulation du genou — Partie 2: Surfaces articulaires constituées de matériaux métalliques, céramiques et plastiques — Amendement 2 Released:6/24/2020
Frequently Asked Questions
ISO 7207-2:2011/Amd 2:2020 is a standard published by the International Organization for Standardization (ISO). Its full title is "Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials - Amendment 2". This standard covers: Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials - Amendment 2
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials - Amendment 2
ISO 7207-2:2011/Amd 2:2020 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 7207-2:2011/Amd 2:2020 has the following relationships with other standards: It is inter standard links to ISO 7207-2:2011, ISO 7207-2:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 7207-2:2011/Amd 2:2020 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 7207-2
Second edition
2011-07-01
AMENDMENT 2
2020-06
Implants for surgery — Components
for partial and total knee joint
prostheses —
Part 2:
Articulating surfaces made of metal,
ceramic and plastics materials
AMENDMENT 2
Implants chirurgicaux — Éléments de prothèses partielle et totale de
l'articulation du genou —
Partie 2: Surfaces articulaires constituées de matériaux métalliques,
céramiques et plastiques
AMENDEMENT 2
Reference number
ISO 7207-2:2011/Amd.2:2020(E)
©
ISO 2020
ISO 7207-2:2011/Amd.2:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 7207-2:2011/Amd.2:2020(E)
Foreword
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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 4, Bone and joint replacements.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
ISO 7207-2:2011/Amd.2:2020(E)
Implants for surgery — Components for partial and total
knee joint prostheses —
Part 2:
Articulating surfaces made of metal, ceramic and plastics
materials
AMENDMENT 2
3.2.1, first paragraph
Replace the paragraph with the following:
When measured in accordance with ISO 4288, all articulating surfaces of a metallic or ceramic femoral
component shall be measured across the articulating surface at characteristic locations. The component
shall have a Ra value of ≤0,1 µm, using a cut-off value of 0,25 mm.
max
When analysing a bi- or tri- compartmental knee joint prosthesis, the roughness of the lateral and
medial condyle of the femoral component
...
NORME ISO
INTERNATIONALE 7207-2
Deuxième édition
2011-07-01
AMENDEMENT 2
2020-06
Implants chirurgicaux — Éléments
de prothèses partielle et totale de
l'articulation du genou —
Partie 2:
Surfaces articulaires constituées de
matériaux métalliques, céramiques et
plastiques
AMENDEMENT 2
Implants for surgery — Components for partial and total knee joint
prostheses —
Part 2: Articulating surfaces made of metal, ceramic and plastics
materials
AMENDMENT 2
Numéro de référence
ISO 7207-2:2011/Amd.2:2020(F)
©
ISO 2020
ISO 7207-2:2011/Amd.2:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020
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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
ISO 7207-2:2011/Amd.2:2020(F)
Avant-propos
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ISO 7207-2:2011/Amd.2:2020(F)
Implants chirurgicaux — Éléments de prothèses partielle
et totale de l'articulation du genou —
Partie 2:
Surfaces articulaires constituées de matériaux métalliques,
céramiques et plastiques
AMENDEMENT 2
3.2.1, premier alinéa
Remplacer l’alinéa par ce qui suit:
Conformément à l’ISO 4288, toutes les surfaces articulaires d’un élément fémoral en métal ou en
céramique doivent être mesurées sur la surface articulaire en des points caractéristiques. L’élément
doit être caractérisé par un
...
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