ISO 5832-7:2024
(Main)Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
Implants chirurgicaux — Matériaux métalliques — Partie 7: Alliage à forger mis en forme à froid à base de cobalt, de chrome, de nickel, de molybdène et de fer
Le présent document spécifie les caractéristiques de l'alliage à forger mis en forme à froid à base de cobalt, de chrome, de nickel, de molybdène et de fer utilisé dans la fabrication des implants chirurgicaux, et les méthodes d'essai correspondantes. NOTE Les propriétés mécaniques d'un échantillon prélevé sur un produit fini fabriqué avec cet alliage peuvent différer de celles spécifiées dans le présent document.
General Information
Relations
Overview
ISO 5832-7:2024 is an international standard published by the International Organization for Standardization (ISO) that specifies requirements for forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy used in surgical implants. This fourth edition replaces the previous 2016 version and harmonizes with the ISO 5832 series, providing updated mechanical testing language and expanded technical details.
This standard defines the chemical composition, microstructure, mechanical properties, and corresponding test methods critical for ensuring the biocompatibility, performance, and safety of metallic materials used in implant manufacturing. It focuses on raw alloy material, not finished medical devices, recognizing that device design and fabrication can further influence biological response.
Key Topics
Chemical Composition: Specifies the precise mass fraction limits for essential elements in the alloy, including cobalt (39.0–42.0%), chromium (18.5–21.5%), nickel (14.0–18.0%), molybdenum (6.5–8.0%), manganese (1.0–2.5%), silicon (up to 1.0%), carbon (max 0.15%), phosphorus (max 0.015%), sulfur (max 0.015%), beryllium (max 0.001%), and balanced iron.
Microstructure:
- Grain size must be uniform and no coarser than grain size No. 5 as defined by ISO 643.
- Non-metallic inclusion content is limited, ensuring minimal sulfides, aluminates, silicates, and oxides as per ISO 4967, promoting alloy purity and implant longevity.
Mechanical Properties:
- Defined minimum tensile strength, proof/yield strength, and elongation based on alloy condition: annealed, hot-worked, cold-worked, or spring temper.
- Example: Annealed alloy must exhibit tensile strength ≥ 950 MPa, yield strength ≥ 450 MPa, and elongation ≥ 65%.
- Specific mechanical property requirements ensure durability and reliability under physiological stresses.
Test Methods:
- Chemical composition analyzed following recognized analytical procedures.
- Microstructure and inclusion content assessed by ISO 643 and ISO 4967, respectively.
- Mechanical properties tested per ISO 6892-1 at room temperature.
- Retest protocols outlined for non-conforming samples to maintain quality control.
Applications
ISO 5832-7:2024 is essential for manufacturers and suppliers involved in producing metallic surgical implants, particularly those requiring biocompatible cobalt-chromium-nickel-molybdenum-iron alloys that can be forged or cold-formed. Typical applications include:
- Orthopedic implants such as joint replacements (hip, knee, shoulder)
- Dental implants requiring high strength and corrosion resistance
- Cardiovascular devices like stents and heart valve components
- Other load-bearing implant components where mechanical reliability and biocompatibility are critical
By adhering to this standard, manufacturers can ensure that implant materials meet stringent international safety and performance criteria, contributing to improved patient outcomes and device longevity.
Related Standards
ISO 5832-7:2024 is part of the broader ISO 5832 series addressing metallic materials for surgical implants. Related standards include:
- ISO 5832-1: Wrought stainless steel for surgical implants
- ISO 5832-2: Nickel-chromium-molybdenum alloy for surgical implants
- ISO 5832-3: Wrought cobalt-chromium alloy
- ISO 4833: Micrographic determination of grain size in steels (complements ISO 643 used in ISO 5832-7)
- ISO 4967: Method for determining non-metallic inclusion content in steels
- ISO 6892-1: Room temperature tensile testing of metallic materials
These complementary standards provide a comprehensive framework for material characterization, quality control, and testing methodologies applicable across various implant alloys and medical device manufacturing processes.
Keywords: ISO 5832-7, surgical implants, cobalt-chromium-nickel-molybdenum-iron alloy, metallic materials for surgery, implant alloy specifications, Forgeable cobalt alloy, cold-formed alloy, medical implant materials, mechanical properties of alloys, biocompatible implant metals, implant manufacturing standards, ISO implant materials, metal microstructure, implant testing standards.
Frequently Asked Questions
ISO 5832-7:2024 is a standard published by the International Organization for Standardization (ISO). Its full title is "Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy". This standard covers: This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
ISO 5832-7:2024 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 5832-7:2024 has the following relationships with other standards: It is inter standard links to ISO 24678-9:2022, ISO 5832-7:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 5832-7:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
International
Standard
ISO 5832-7
Fourth edition
Implants for surgery — Metallic
2024-04
materials —
Part 7:
Forgeable and cold-formed cobalt-
chromium-nickel-molybdenum-
iron alloy
Implants chirurgicaux — Matériaux métalliques —
Partie 7: Alliage à forger mis en forme à froid à base de cobalt, de
chrome, de nickel, de molybdène et de fer
Reference number
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Chemical composition . 1
5 Microstructure. 2
5.1 Grain size .2
5.2 Inclusion content .2
6 Mechanical properties . 2
7 Test methods . 3
iii
Foreword
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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials, in collaboration with the European Committee for Standardizat
...
Norme
internationale
ISO 5832-7
Quatrième édition
Implants chirurgicaux — Matériaux
2024-04
métalliques —
Partie 7:
Alliage à forger mis en forme à froid
à base de cobalt, de chrome, de
nickel, de molybdène et de fer
Implants for surgery — Metallic materials —
Part 7: Forgeable and cold-formed cobalt-chromium-nickel-
molybdenum-iron alloy
Numéro de référence
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2024
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
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ISO copyright office
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CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Composition chimique . 1
5 Microstructure. 2
5.1 Grosseur de grain .2
5.2 Teneur en inclusions .2
6 Propriétés mécaniques . 2
7 Méthodes d’essai . 3
iii
Avant-propos
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Le présent document a été élaboré par le comité technique ISO/TC 150, Implants chirurgicaux, sous-
comité SC 1, Matériaux, en collaboration avec le comité technique CEN/TC 285, Implants chirurgicaux non
actifs, du Comité européen de normalisation (CEN) conformément à l’Accord de coopération technique entre
l’ISO et le CEN (Accord de Vienne).
Cette quatrième édition annule et remplace la troisième édition (ISO 5832-7:2016) qui a fait l’objet d’une
révision technique.
Les princ
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