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part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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
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.
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
ISO 5832-1:2016(E)
© 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
Ch. de Blandonnet 8 • CP 401
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
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 . 3
6.2 Tensile test . 3
6.3 Gauge length . 3
7 Test methods . 3
Bibliography . 6
ISO 5832-1:2016(E)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 1,
Materials.
This fifth edition cancels and replaces the fourth edition (ISO 5832-1:2007), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 5832-1:2007/Cor 1:2008.
ISO 5832 consists of the following parts, under the general title Implants for surgery — Metallic materials:
— Part 1: Wrought stainless steel
— Part 2: Unalloyed titanium
— Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
— Part 4: Cobalt-chromium-molybdenum casting alloy
— Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
— Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
— Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
— Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy
— Part 9: Wrought high nitrogen stainless steel
— Part 11: Wrought titanium 6-aluminium 7-niobium alloy
— Part 12: Wrought cobalt-chromium-molybdenum alloy
— Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
iv © ISO 2016 – All rights reserved
ISO 5832-1:2016(E)
Introduction
No known surgical implant material has ever been shown to be completely free of adverse reactions in
the human body. However, long-term clinical experience of the use of the material referred to in this
part of ISO 5832 has shown that an acceptable level of biological response can be expected when the
material is used in appropriate applications.
The following definitions apply in understanding how to implement an ISO International Standard and
other normative ISO deliverables (TS, PAS, IWA):
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” is used to indicate that something is permitted;
— “can” is used to indicate that something is possible, for example, that an organization or individual
is able to do something.
3.3.1 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a requirement as an “expression in
the content of a document conveying criteria to be fulfilled if compliance with the document is to be
claimed and from which no deviation is permitted.”
3.3.2 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a recommendation as an “expression
in the content of a document conveying that among several possibilities one is recommended as
particularly suitable, without mentioning or excluding others, or that a certain course of action is
preferred but not necessarily required, or that (in the negative form) a certain possibility or course of
action is deprecated but not prohibited.”
INTERNATIONAL STANDARD ISO 5832-1:2016(E)
Implants for surgery — Metallic materials —
Part 1:
Wrought stainless steel
1 Scope
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought
stainless steel for
...
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