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CEN

EN ISO 5832-1:2024

(Main)

Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)

Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)

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.

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)

Le présent document spécifie les caractéristiques de l'acier inoxydable corroyé utilisé dans la fabrication des implants chirurgicaux, et les méthodes d'essai correspondantes.
NOTE 1       Les propriétés mécaniques d'un échantillon prélevé sur un produit fini fabriqué avec cet alliage peuvent différer de celles spécifiées dans le présent document.
NOTE 2       L'alliage décrit dans le présent document correspond à la nuance UNS S31673 dans l'ASTM F138 et l'ASTM F139.

Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO 5832-1:2024)

General Information

Status
Published
Publication Date
09-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
10-Apr-2024
Completion Date
10-Apr-2024
Ref Project
SIST EN ISO 5832-1:2024 - Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)

Relations

Replaces
EN ISO 5832-1:2019 - Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
Effective Date
19-Jan-2023

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5832-1:2024
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
SIST EN ISO 5832-1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 5832-1:2024

---------------------- Page: 2 ----------------------
SIST EN ISO 5832-1:2024


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.

---------------------- Page: 3 ----------------------
SIST EN ISO 5832-1:2024
EN ISO 5832-1:2024 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 5832-1:2024
EN ISO 5832-1:2024 (E)
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.

3

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SIST EN ISO 5832-1:2024

---------------------- Page: 6 ----------------------
...

SLOVENSKI STANDARD
oSIST prEN ISO 5832-1:2023
01-maj-2023
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO/DIS
5832-1:2023)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO/DIS 5832-
1:2023)
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO/DIS
5832-1:2023)
Implants chirurgicaux - Matériaux métalliques - Partie 1: Acier inoxydable corroyé
(ISO/DIS 5832-1:2023)
Ta slovenski standard je istoveten z: prEN ISO 5832-1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 5832-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 5832-1:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 5832-1:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5832-1
ISO/TC 150/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-02-27 2023-05-22
Implants for surgery — Metallic materials —
Part 1:
Wrought stainless steel
Implants chirurgicaux — Produits à base de métaux —
Partie 1: Acier inoxydable corroyé
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5832-1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 5832-1:2023
ISO/DIS 5832-1:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5832-1
ISO/TC 150/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:

Implants for surgery — Metallic materials —
Part 1:
Wrought stainless steel
Implants chirurgicaux — Produits à base de métaux —
Partie 1: Acier inoxydable corroyé
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 5832-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 5832-1:2023
ISO/DIS 5832-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references .
...

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