EN ISO 5832-1:2019
(Main)Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
ISO 5832-1:2016 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 part of ISO 5832.
NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO 5832-1:2016)
Dieser Teil der ISO 5832 legt die Eigenschaften und die zu deren Bestimmung anzuwendenden Prüfmethoden für nichtrostenden Stahl zur Verwendung für die Herstellung von chirurgischen Implantaten fest.
ANMERKUNG 1 Die mechanischen Eigenschaften einer Probe, die aus einem Fertigprodukt der hier beschriebenen Legierung entnommen wurde, können von den in diesem Teil der ISO 5832 festgelegten abweichen.
ANMERKUNG 2 Die in diesem Teil der ISO 5832 beschriebene Legierung stimmt mit UNS S31673 wie in ASTM F 138/ASTM F 139 und mit dem in der zurückgezogenen DIN 17443 angegebenen Legierungscode 1.4441 überein.
Implants chirurgicaux - Produits à base de métaux - Partie 1: Acier inoxydable corroyé (ISO 5832-1:2016)
L'ISO 5832-1:2016 définit les caractéristiques applicables à l'acier corroyé inoxydable utilisé dans la fabrication des implants chirurgicaux, ainsi que 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 la présente partie de l'ISO 5832.
NOTE 2 L'acier décrit dans la présente partie de l'ISO 5832 correspond à la nuance UNS S31673 mentionnée dans l'ASTM F138 et dans l'ASTM F139 ainsi qu'à l'alliage de code 1.4441 indiqué dans la DIN 17443.
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO 5832-1:2016)
Standard ISO 5832-1:2016 določa lastnosti in zadevne preskusne metode za nerjavno jeklo, ki se uporablja pri izdelavi vsadkov (implantatov) za kirurgijo.
OPOMBA 1: Mehanske lastnosti vzorca končnega izdelka iz te zlitine se lahko razlikujejo od lastnosti, ki so določene v tem delu standarda ISO 5832.
OPOMBA 2: Zlitina, ki je opisana v tem delu standarda ISO 5832, ustreza jeklu UNS S31673 iz standarda ASTM F138/ASTM F139 in oznaki zlitine 1.4441 iz umaknjenega standarda DIN 17443.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5832-1:2019
01-december-2019
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO
5832-1:2016)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-
1:2016)
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO 5832
-1:2016)
Implants chirurgicaux - Produits à base de métaux - Partie 1: Acier inoxydable corroyé
(ISO 5832-1:2016)
Ta slovenski standard je istoveten z: EN ISO 5832-1:2019
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5832-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5832-1:2019
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SIST EN ISO 5832-1:2019
EN ISO 5832-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Implants for surgery - Metallic materials - Part 1: Wrought
stainless steel (ISO 5832-1:2016)
Implants chirurgicaux - Produits à base de métaux - Chirurgische Implantate - Metallische Werkstoffe - Teil
Partie 1: Acier inoxydable corroyé (ISO 5832-1:2016) 1: Nichtrostender Stahl (ISO 5832-1:2016)
This European Standard was approved by CEN on 2 September 2019.
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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-1:2019 E
worldwide for CEN national Members.
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SIST EN ISO 5832-1:2019
EN ISO 5832-1:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 5832-1:2019
EN ISO 5832-1:2019 (E)
European foreword
The text of ISO 5832-1:2016 has been prepared by Technical Committee ISO/TC 150 "Implants for
surgery” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 5832-1:2019 by 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 April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
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.
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 5832-1:2016 has been approved by CEN as EN ISO 5832-1:2019 without any
modification.
3
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SIST EN ISO 5832-1:2019
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SIST EN ISO 5832-1:2019
INTERNATIONAL ISO
STANDARD 5832-1
Fifth edition
2016-07-15
Implants for surgery — Metallic
materials —
Part 1:
Wrought stainless steel
Implants chirurgicaux
...
SLOVENSKI STANDARD
oSIST prEN ISO 5832-1:2018
01-november-2018
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO
5832-1:2016)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-
1:2016)
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO 5832
-1:2016)
Implants chirurgicaux - Produits à base de métaux - Partie 1: Acier inoxydable corroyé
(ISO 5832-1:2016)
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 5832-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5832-1:2018
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oSIST prEN ISO 5832-1:2018
INTERNATIONAL ISO
STANDARD 5832-1
Fifth edition
2016-07-15
Implants for surgery — Metallic
materials —
Part 1:
Wrought stainless steel
Implants chirurgicaux — Produits à base de métaux —
Partie 1: Acier inoxydable corroyé
Reference number
ISO 5832-1:2016(E)
©
ISO 2016
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oSIST prEN ISO 5832-1:2018
ISO 5832-1:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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oSIST prEN ISO 5832-1:2018
ISO 5832-1:2016(E)
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 . 2
5.3 Inclusion content. 3
6 Mechanical properties . 3
6.1 Test pieces .
...
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