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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 2024
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ii
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
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
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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).
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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 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
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 m
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