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part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.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
Frequently Asked Questions
EN ISO 5832-1:2019 is a standard published by the European Committee for Standardization (CEN). Its full title is "Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)". This standard covers: 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.
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.
EN ISO 5832-1:2019 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 5832-1:2019 has the following relationships with other standards: It is inter standard links to EN ISO 5832-1:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 5832-1:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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 t
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표준 EN ISO 5832-1:2019는 외과용 임플란트 제조에 사용되는 가공 스테인리스강의 특성과 해당 시험 방법을 명시하고 있습니다. 이 표준은 외과용 임플란트를 위한 금속 재료의 신뢰성을 높이는 데 기여하며, 의료 기기의 안전성과 효율성을 보장하는 데 필수적인 역할을 합니다. EN ISO 5832-1:2019의 강점 중 하나는 고유한 기계적 특성을 정의하고, 이와 관련된 시험 방법을 통해 제조업체들이 품질 높은 제품을 생산할 수 있도록 지원한다는 점입니다. 또한, 이 표준에 포함된 특성들은 실제 임상 환경에서의 임플란트 성능을 반영하며, 이를 통해 환자에게 보다 안전한 의료 서비스를 제공할 수 있습니다. 특히, 이 표준의 relevance는 의료 기기 규제와 품질 관리 시스템에 있어 매우 높습니다. UNS S31673에 해당하는 합금은 ASTM F138 및 ASTM F139에서 참조되고 있으며, DIN 17443에서 철회된 합금 코드 1.4441과도 일치합니다. 이러한 표준화는 국제적으로 통일된 기준을 설정하여, 전 세계 의료 기기 시장에서 수출입 및 상용화 과정에서 발생할 수 있는 혼란을 줄이는 데 기여합니다. 결론적으로, EN ISO 5832-1:2019는 외과용 임플란트 분야에서의 전문성과 안전성을 확보하기 위한 필수적인 기준이며, 이를 준수함으로써 제조업체와 의료 기관 모두 이익을 얻을 수 있습니다.
EN ISO 5832-1:2019は、外科インプラントの製造に使用される鍛造ステンレス鋼の特性と対応する試験方法を規定した重要な標準です。この標準の範囲は、手術用インプラントに関する金属材料に焦点を当てており、特にUNS S31673やDIN 17443で定義された合金コード1.4441に関連しています。標準は、手術インプラントの安全性と性能を保証する上で不可欠な基準を提供しています。 この標準の強みは、詳細な機械的特性に関する情報を提供し、実際の使用における合金の挙動を理解するための試験方法を明確に示している点です。特に、完成品から得られるサンプルの機械的特性が、ISO 5832の規定と異なる可能性があることを考慮に入れている点は、実際のアプリケーションにおけるリスク管理に貢献します。 また、EN ISO 5832-1:2019は医療分野における合金の採用において、国際的な基準を確立しており、世界中の医療機器メーカーにとって重要な参考となります。標準は、製品の設計・製造・品質管理に関連するすべてのステークホルダーに対して、信頼性が高く、科学的根拠に基づいた指針を提供するものです。これにより、手術インプラントの品質向上が期待でき、患者の安全性向上に寄与します。 従って、EN ISO 5832-1:2019は、手術用インプラントにおける鍛造ステンレス鋼の特性を明確にし、それに基づく試験を通じて、医療機器の安全性と効果を確保するための不可欠な標準としての地位を確立しています。
Die Norm EN ISO 5832-1:2019 legt die Eigenschaften sowie die entsprechenden Prüfmethoden für gewalzten rostfreien Stahl fest, der in der Herstellung von chirurgischen Implantaten verwendet wird. Diese Norm deckt einen wichtigen Bereich im Bereich der Medizintechnik ab, da sie die Qualitätsstandards für Materialien, die im direkten Kontakt mit dem menschlichen Körper stehen, definiert und sicherstellt, dass diese Materialien sowohl funktional als auch sicher sind. Ein herausragendes Merkmal dieser Norm ist die detaillierte Spezifikation der mechanischen Eigenschaften, die für den Einsatz in chirurgischen Implantaten erforderlich sind. Diese Eigenschaften umfassen Festigkeit, Zugfestigkeit und Duktilität, was für die Langlebigkeit und Sicherheit der Implantate von entscheidender Bedeutung ist. Darüber hinaus werden durch bestimmte Prüfmethoden die Eigenschaften des Materials validiert, was die Relevanz dieser Norm unterstreicht. Die Norm ist besonders relevant für Hersteller von chirurgischen Implantaten, da sie sicherstellt, dass nur Materialien verwendet werden, die strengen Anforderungen entsprechen und um eine konsistente Qualität zu garantieren. Dies ist essentiell, um Komplikationen in der Patientenversorgung zu vermeiden und das Vertrauen in medizinische Produkte zu stärken. Ein weiterer Stärke der EN ISO 5832-1:2019 ist die Klarstellung, dass die mechanischen Eigenschaften einer Probe aus einem Fertigprodukt von denen abweichen können, die in dieser Norm angegeben sind. Diese Information ist entscheidend für die Hersteller, um potenzielle Risiken bei der Anwendung der Materialien besser einschätzen zu können und um die Produktentwicklung gezielt zu steuern. Zusammenfassend lässt sich sagen, dass die EN ISO 5832-1:2019 nicht nur eine essentielle Grundlage für die Auswahl und Prüfung von rostfreiem Stahl in chirurgischen Implantaten bietet, sondern auch einen wichtigen Beitrag zur Sicherheit und Effizienz in der chirurgischen Praxis leistet. Die Norm trägt damit maßgeblich zur Verbesserung der Patientenversorgung bei und ist ein unverzichtbares Referenzdokument für alle Beteiligten in der Medizintechnikbranche.
La norme EN ISO 5832-1:2019 spécifie les caractéristiques et les méthodes d'essai des aciers inoxydables, forgés pour l'utilisation dans la fabrication d'implants chirurgicaux. Son champ d'application est crucial pour garantir que les matériaux utilisés dans les implants répondent aux exigences de sécurité et de performance élevées nécessaires dans le domaine de la médecine. Une des forces majeures de cette norme est sa capacité à fournir des spécifications claires sur les propriétés mécaniques des alliages d'acier inoxydable, ainsi que les méthodes d’évaluation associées. Cela assure non seulement une qualité uniforme des matériaux utilisés, mais aussi une compatibilité avec les exigences légales et réglementaires en matière d'implants médicaux. De plus, la référence à l'alliage UNS S31673 et à son équivalent dans les normes ASTM, ainsi que le code d'alliage 1.4441, démontre la pertinence et l’harmonisation de cette norme avec d'autres standards internationaux. Cela facilite l'intégration des matériaux dans divers systèmes réglementaires, rendant ainsi l'EN ISO 5832-1:2019 particulièrement pertinente pour les fabricants et les développeurs d'implants chirurgicaux. En somme, cette norme joue un rôle fondamental dans l’industrie des dispositifs médicaux en établissant des critères techniques rigoureux pour les aciers inoxydables, ce qui in fine, contribue à améliorer la sécurité des patients et l’efficacité des interventions chirurgicales.
The standard EN ISO 5832-1:2019 provides a comprehensive framework for evaluating wrought stainless steel used in surgical implants, specifically aligning with ISO 5832-1:2016. This document rigorously details the required characteristics and test methods for the metallic materials that are crucial in the production of surgical implants. One of the notable strengths of this standard is its meticulous specification of mechanical properties, ensuring that materials meet rigorous safety and efficacy requirements essential for medical applications. The standard recognizes that mechanical properties of samples taken from finished products may differ, thereby providing clarity and guidance for manufacturers to account for variability in production processes. This consideration is critical in maintaining the integrity and reliability of medical implants. Furthermore, the relevance of this standard is underscored by its alignment with established codes such as UNS S31673, ASTM F138, F139, and the previously utilized DIN 17443 alloy code 1.4441. This connection to other recognized standards facilitates a smoother transition for manufacturers aiming to comply with international regulations while allowing for broader acceptance in the global market. Overall, EN ISO 5832-1:2019 stands out for its thorough approach to safety and quality in the field of surgical implants, emphasizing the importance of wrought stainless steel as a material choice in the medical device industry. The standard not only supports manufacturers in meeting essential criteria but also plays a pivotal role in promoting patient safety through standardized practices.
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