SIST EN ISO 5832-6:2022

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)

This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel chromium-molybdenum alloy for use in the manufacture of surgical implants.
NOTE      The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

Chirurgische Implantate - Metallische Werkstoffe - Teil 6: Kobalt-Nickel-Chrom-Molybdän-Schmiedelegierung (ISO 5832-6:2022)

Dieses Dokument legt die Eigenschaften von und die entsprechenden Prüfverfahren für geschmiedete Kobalt-Nickel-Chrom-Molybdän-Legierungen fest, die zur Herstellung von chirurgischen Implantaten verwendet werden.
ANMERKUNG   Die Zugeigenschaften einer Probe, die einem Fertigprodukt aus der hier beschriebenen Legierung entnommen wurde, stimmen nicht notwendigerweise mit denen in diesem Dokument festgelegten überein.

Implants chirurgicaux - Matériaux métalliques - Partie 6: Alliage corroyé à base de cobalt, de nickel, de chrome et de molybdène (ISO 5832-6:2022)

Le présent document définit les caractéristiques et les méthodes d'essai correspondantes de l'alliage corroyé à base de cobalt, de nickel, de chrome et de molybdène, utilisé pour fabriquer des implants chirurgicaux.
NOTE      Les caractéristiques d'un échantillon prélevé sur un produit fini fabriqué avec cet alliage ne sont pas nécessairement conformes à celles spécifiées dans le présent document.

Vsadki (implantati) za kirurgijo - Kovinski materiali - 6. del: Kobalt-nikelj-krom-molibdenova kovana zlitina (ISO 5832-6:2022)

Ta dokument določa lastnosti in zadevne preskusne metode za kobalt-nikelj-krom-molibdenovo kovano zlitino, ki se uporablja pri izdelavi vsadkov (implantatov) za kirurgijo.
OPOMBA: Natezne lastnosti vzorca končnega izdelka iz te zlitine niso nujno v skladu z lastnostmi, ki so določene v tem dokumentu.

General Information

• Status: Published
• Public Enquiry End Date: 19-Apr-2021
• Publication Date: 12-May-2022
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 25-Apr-2022
• Due Date: 30-Jun-2022
• Completion Date: 13-May-2022
• Ref Project: EN ISO 5832-6:2022 - Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)

Relations

• Replaces: SIST EN ISO 5832-6:2019 - Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)
• Effective Date: 01-Jun-2022

Overview

EN ISO 5832-6:2022 - "Implants for surgery - Metallic materials - Part 6: Wrought cobalt‑nickel‑chromium‑molybdenum alloy" specifies the required chemical composition, microstructure, tensile properties and corresponding test methods for wrought Co–Ni–Cr–Mo alloys used as raw material in the manufacture of surgical implants. Published by CEN/ISO, this standard applies to the base material (not finished devices) and is part of the ISO 5832 series for implant metallic materials.

Key topics and technical requirements

• Chemical composition (heat analysis): the alloy composition limits include, for example:
  • Nickel: 33.0–37.0%
  • Chromium: 19.0–21.0%
  • Molybdenum: 9.0–10.5%
  • Boron: ≤ 0.015% and limits for Fe, Ti, Mn, Si, C, P, S; Cobalt as balance.
• Microstructure
  • Microstructure must be uniform.
  • Grain size in the annealed condition shall be not coarser than grain size No. 4 (per ISO 643).
• Tensile properties (tested per ISO 6892‑1): specified minimum values by condition:
  • Annealed: Tensile strength Rm ≥ 793 MPa, Proof/Yield Rp0.2 ≥ 300 MPa, Elongation A ≥ 50%
  • Medium hard: Rm ≥ 1 000 MPa, Rp0.2 ≥ 655 MPa, A ≥ 20%
  • Hard: Rm ≥ 1 207 MPa, Rp0.2 ≥ 1 000 MPa, A ≥ 10%
  • Note: tensile properties can be altered by cold‑working and ageing; tensile results from finished product samples may not reflect these raw‑material values.
• Test methods & conformity
  • Chemical analysis, grain size (ISO 643) and tensile testing (ISO 6892‑1) are referenced.
  • Retest and failure handling procedures are defined for conformity assessment.

Applications and practical value

• Material specification for manufacturers of orthopaedic and trauma implants, dental implants, and other non‑active surgical implants where Co–Ni–Cr–Mo alloys are chosen for strength and corrosion resistance.
• Used by material suppliers, medical device OEMs, quality/acceptance laboratories, and regulatory/standards teams to:
  • Verify raw‑material compliance before device fabrication.
  • Define procurement specifications and supplier contracts.
  • Support regulatory submissions and technical documentation.

Who should use this standard

• Implant manufacturers, metallurgists, procurement and quality engineers, test laboratories, and regulatory compliance personnel involved with metallic implant materials.

Related standards

• ISO 5832 series (other metallic implant materials)
• ISO 643 - Micrographic determination of apparent grain size
• ISO 6892‑1 - Tensile testing of metallic materials

This standard provides authoritative, testable requirements for wrought Co–Ni–Cr–Mo implant alloy supply and acceptance, helping ensure material consistency, safety, and traceability in surgical implant manufacturing.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2022
Nadomešča:
SIST EN ISO 5832-6:2019
Vsadki (implantati) za kirurgijo - Kovinski materiali - 6. del: Kobalt-nikelj-krom-
molibdenova kovana zlitina (ISO 5832-6:2022)
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-
molybdenum alloy (ISO 5832-6:2022)
Chirurgische Implantate - Metallische Werkstoffe - Teil 6: Kobalt-Nickel-Chrom-
Molybdän-Schmiedelegierung (ISO 5832-6:2022)
Implants chirurgicaux - Matériaux métalliques - Partie 6: Alliage corroyé à base de
cobalt, de nickel, de chrome et de molybdène (ISO 5832-6:2022)
Ta slovenski standard je istoveten z: EN ISO 5832-6:2022
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 5832-6
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-6:2019
English Version
Implants for surgery - Metallic materials - Part 6: Wrought
cobalt-nickel-chromium-molybdenum alloy (ISO 5832-
6:2022)
Implants chirurgicaux - Matériaux métalliques - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil
6: Alliage corroyé à base de cobalt, de nickel, de 6: Kobalt-Nickel-Chrom-Molybdän-Schmiedelegierung
chrome et de molybdène (ISO 5832-6:2022) (ISO 5832-6:2022)
This European Standard was approved by CEN on 20 March 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-6:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 5832-6:2022) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical
implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2022, and conflicting national standards
shall be withdrawn at the latest by September 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 5832-6:2019.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 5832-6:2022 has been approved by CEN as EN ISO 5832-6:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 5832-6
Third edition
2022-03
Implants for surgery — Metallic
materials —
Part 6:
Wrought cobalt-nickel-chromium-
molybdenum alloy
Implants chirurgicaux — Matériaux métalliques —
Partie 6: Alliage corroyé à base de cobalt, de nickel, de chrome et de
molybdène
Reference number
ISO 5832-6:2022(E)
ISO 5832-6:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii
ISO 5832-6:2022(E)
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 General . 2
5.2 Grain size index . 2
6 Tensile properties .
...