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EN ISO 5832-7:2024

(Main)

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)

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.

Chirurgische Implantate - Metallische Werkstoffe - Teil 7: Schmiedbare und kaltumformbare Cobalt-Chrom-Nickel-Molybdän-Eisenlegierung (ISO 5832-7:2024)

Dieses Dokument legt Eigenschaften und die entsprechenden Prüfverfahren für eine schmiedbare und kaltumformbare Cobalt Chrom Nickel Molybdän Eisenlegierung fest, die zur Herstellung von chirurgischen Implantaten verwendet wird.
ANMERKUNG   Die mechanischen Eigenschaften einer Probe, die einem Fertigprodukt aus der hier beschriebenen Legierung entnommen wurde, können von den in diesem Dokument festgelegten abweichen.

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 (ISO 5832-7:2024)

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.

Vsadki (implantati) za kirurgijo - Kovinski materiali - 7. del: Kovne in hladno oblikovane kobalt-krom-nikelj-molibden-železove zlitine (ISO 5832-7:2024)

Standard ISO 5832-7:2016 določa lastnosti in ustrezne preskusne metode za kovne ter hladno oblikovane kobalt-krom-nikelj-molibden-železove zlitine, ki se uporabljajo pri izdelavi vsadkov (implantatov) za kirurgijo.

General Information

Status
Published
Publication Date
16-Apr-2024
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
17-Apr-2024
Completion Date
17-Apr-2024
Ref Project
SIST EN ISO 5832-7:2024 - Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)

Relations

Replaces
EN ISO 5832-7:2019 - Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
Effective Date
06-Oct-2021

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SLOVENSKI STANDARD
01-junij-2024
Vsadki (implantati) za kirurgijo - Kovinski materiali - 7. del: Kovne in hladno
oblikovane kobalt-krom-nikelj-molibden-železove zlitine (ISO 5832-7:2024)
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-
chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)
Chirurgische Implantate - Metallische Werkstoffe - Teil 7: Schmiedbare und
kaltumformbare Cobalt-Chrom-Nickel-Molybdän-Eisenlegierung (ISO 5832-7:2024)
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 (ISO 5832-7:2024)
Ta slovenski standard je istoveten z: EN ISO 5832-7:2024
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 5832-7
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-7:2019
English Version
Implants for surgery - Metallic materials - Part 7:
Forgeable and cold-formed cobalt-chromium-nickel-
molybdenum-iron alloy (ISO 5832-7:2024)
Implants chirurgicaux - Matériaux métalliques - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil
7: Alliage à forger mis en forme à froid à base de cobalt, 7: Schmiedbare und kaltumformbare Cobalt-Chrom-
de chrome, de nickel, de molybdène et de fer (ISO Nickel-Molybdän-Eisenlegierung (ISO 5832-7:2024)
5832-7:2024)
This European Standard was approved by CEN on 17 June 2023.

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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-7:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 5832-7:2024) 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 October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
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 5832-7:2019.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5832-7:2024 has been approved by CEN as EN ISO 5832-7:2024 without any
modification.
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 5832-7:2024(en) © ISO 2024

ISO 5832-7:2024(en)
© ISO 2024
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
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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
ISO 5832-7:2024(en)
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 .
...

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