EN ISO 5832-1:2024

SLOVENSKI STANDARD
01-junij-2024
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO
5832-1:2024)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-
1:2024)
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO 5832
-1:2024)
Implants chirurgicaux - Matériaux métalliques - Partie 1: Acier inoxydable corroyé (ISO
5832-1:2024)
Ta slovenski standard je istoveten z: EN ISO 5832-1:2024
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 5832-1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-1:2019
English Version
Implants for surgery - Metallic materials - Part 1: Wrought
stainless steel (ISO 5832-1:2024)
Implants chirurgicaux - Matériaux métalliques - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil
1: Acier inoxydable corroyé (ISO 5832-1:2024) 1: Nichtrostender Stahl (ISO 5832-1:2024)
This European Standard was approved by CEN on 23 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 5832-1:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 5832-1:2024) 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 5832-1:2019.
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 5832-1:2024 has been approved by CEN as EN ISO 5832-1:2024 without any
modification.
International
Standard
ISO 5832-1
Sixth edition
Implants for surgery — Metallic
2024-04
materials —
Part 1:
Wrought stainless steel
Implants chirurgicaux — Matériaux métalliques —
Partie 1: Acier inoxydable corroyé
Reference number
ISO 5832-1:2024(en) © ISO 2024

ISO 5832-1:2024(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 5832-1:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Chemical composition . 2
4.1 Test samples .2
4.2 Cast analysis .2
5 Microstructure in the fully annealed condition . 2
5.1 Grain size .2
5.2 Microstructure .3
5.3 Inclusion content .3
6 Mechanical properties . 3
6.1 Test pieces . .3
6.2 Tensile test .3
6.3 Gauge length .3
7 Test methods . 3
Bibliography . 6

iii
ISO 5832-1:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 285, Non-active surgical implants, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
This sixth edition cancels and replaces the fifth edition (ISO 5832-1:2016), which has been technically
revised.
The main changes are as follows:
— the introduction has been updated;
— normative references have been updated;
— the requirement for silicon in Table 1 has been changed to 0,75 max;
— the requirement for cobalt in Table 1 has been added;
— requirements for mechanical properties in Table 4 have been updated;
— this document has been harmonized with the ISO 5832 series.
A list of all parts in the ISO 5832 series can be found on the ISO website.
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.

iv
ISO 5832-1:2024(en)
Introduction
While no known surgical implant material has ever been shown to cause absolutely no adverse reactions
in the human body, long-term clinical experience with the material referred to in this document has shown
that an acceptable level of biological response can be expected when the material is used in appropriate
applications. However, this document covers the raw material and not finished medical devices, where the
design and fabrication of the device can impact biological response.

v
International Standard ISO 5832-1:2024(en)
Implants for surgery — Metallic materials —
Part 1:
Wrought stainless steel
1 Scope
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel
for use in the manufacture of surgical implants.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from
those specified in this document.
NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.
2 Normativ
...