EN ISO 21535:2009
(Main)Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
ISO 21535:2007 provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)
Diese Internationale Norm legt besondere Anforderungen an Implantate für den Hüftgelenkersatz fest. Unter
Berücksichtigung der Sicherheit legt diese Internationale Norm Anforderungen an die vorgesehene Funktion,
Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung, die Bereitstellung
von Informationen durch den Hersteller und Prüfverfahren fest.
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO 21535:2007)
L'ISO 21535:2007 fournit des exigences spécifiques relatives aux prothèses de remplacement de l'articulation de la hanche. En matière de sécurité, la présente Norme internationale spécifie des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant, ainsi que des méthodes d'essai.
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk (ISO 21535:2007)
Ta mednarodni standard navaja posebne zahteve za umetni kolk. V zvezi z varnostjo ta mednarodni standard določa zahteve za predvideno zmogljivost, obliko, materiale, ovrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec, ter preskusne metode.
General Information
Relations
Frequently Asked Questions
EN ISO 21535:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)". This standard covers: ISO 21535:2007 provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
ISO 21535:2007 provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.
EN ISO 21535:2009 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 21535:2009 has the following relationships with other standards: It is inter standard links to EN ISO 21535:2007, EN ISO 21535:2024, EN ISO 21535:2009/A1:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 21535:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 21535:2009 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-julij-2009
1DGRPHãþD
SIST EN ISO 21535:2008
Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za
umetni kolk (ISO 21535:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-
joint replacement implants (ISO 21535:2007)
Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere
Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007)
Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences
spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO
21535:2007)
Ta slovenski standard je istoveten z: EN ISO 21535:2009
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.
EUROPEAN STANDARD
EN ISO 21535
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 21535:2007
English Version
Non-active surgical implants - Joint replacement implants -
Specific requirements for hip-joint replacement implants (ISO
21535:2007)
Implants chirurgicaux non actifs - Implants de Nichtaktive chirurgische Implantate - Implantate zum
remplacement d'articulation - Exigences spécifiques Gelenkersatz - Besondere Anforderungen an Implantate für
relatives aux implants de remplacement de l'articulation de den Hüftgelenkersatz (ISO 21535:2007)
la hanche (ISO 21535:2007)
This European Standard was approved by CEN on 12 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21535:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
The text of ISO 21535:2007 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 21535:2009 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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21535:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 21535:2007 has been approved by CEN as a EN ISO 21535:2009 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub- Essential Requirements (ERs) of Qualifying remarks/Notes
clause(s) of this EN Directive 93/42/EEC
4 1, 2, 3, 4, 5, 7.1, 7.2, 9.2 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard. The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.
5 1, 2, 3, 4, 5, 6, 7.1, 9.1, 9.2 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard .The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.
6 1, 2, 3, 4, 7.1, 7.2, 7.3, 7.4, 8.2, 9.1, The part of ER 1 relating to the risk of
9.2 use error is not addressed in this
European Standard .The part of ER 7.1
relating to results of biophysical and
modelling research is not addressed by
this European Standard.The part of ER
7.4 relating to the regulatory provision
for the verification of the medicinal
product is not addressed in this
European Standard.
7 1, 2, 3, 4, 5, 6, 6a., 7.1, 7.2, 7.3, The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results of
biophysical and modelling research is
not addressed by this European
Standard.
8 1, 2, 3, 4, 5, 7.1, 7.2, 7.3 The part of ER 1 relating to the risk of
use error is not addressed in this
European Standard.
The part of ER 7.1 relating to results of
biophysical and modelling research is
not addressed by this European
Standard.
9 3, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7, 13.3 Via ISO 14630
The modification of ER 13.3 f is not
addressed in this European Standard.
10 3, 5, 7.2, 8.1, 8.3, 8.4, 8.5, 8.6, 8.7 Via ISO 14630
11 9.1, 13 The part of ER 13.3.a concerning the
information on the authorized
representative is not addressed in this
European Standard.
ER 13.3 f is only partly addressed in
this European Standard: safety issue of
single use.
ER 13.6 q is not addressed by this
International Standard.
NOTE Clauses 4, 5, 6, 7, 8 and subclause 11.5 supplement and are dependent on the corresponding clauses of
ISO 21534.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 21535
Second edition
2007-10-01
Non-active surgical implants — Joint
replacement implants — Specific
requirements for hip-joint replacement
implants
Implants chirurgicaux non actifs — Implants de remplacement
d'articulation — Exigences spécifiques relatives aux implants de
remplacement de l'articulation de la hanche
Reference number
ISO 21535:2007(E)
©
ISO 2007
ISO 21535:2007(E)
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ii © ISO 2007 – All rights reserved
ISO 21535:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Intended performance . 2
5 Design attributes. 3
5.1 General. 3
5.2 Tolerances and dimensions . 3
5.3 Thickness of UHMWPE in acetabular components and bipolar heads. 3
6 Materials . 3
7 Design evaluation . 4
7.1 General. 4
7.2 Preclinical evaluation . 4
8 Manufacture. 4
9 Sterilization. 5
10 Packaging . 5
11 Information to be supplied by the manufacturer. 5
11.1 General. 5
11.2 Dimensions. 5
11.3 Structural and functional compatibility of components. 5
11.4 Marking . 5
11.5 Information for the patient . 6
Annex A (informative) Evaluation of relative angular motion of components. 7
Bibliography . 9
ISO 21535:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 21535 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 4,
Bone and joint replacements.
This second edition cancels and replaces the first edition (ISO 21535:2002), which has been technically
revised.
iv © ISO 2007 – All rights reserved
ISO 21535:2007(E)
Introduction
There are three levels of International Standard dealing with non-active surgical implants. These are as
follows, with level 1 being the highest:
⎯ level 1: general requirements for non-active surgical implants and instrumentation used in association
with implants;
⎯ level 2: particular requirements for families of non-ac
...
Die EN ISO 21535:2009 ist eine wesentliche Norm, die spezifische Anforderungen an Hüftgelenkersatzimplantate definiert. Ihr Anwendungsbereich erstreckt sich auf alle nicht aktiven chirurgischen Implantate, die zum Ersatz des Hüftgelenks verwendet werden. Die Norm stellt sicher, dass diese Implantate sowohl sicher als auch effektiv sind, indem sie klare Vorgaben zur beabsichtigten Leistung festlegt. Ein herausragendes Merkmal dieser Norm ist die umfassende Betrachtung von Designattributen und Materialien, die für die Herstellung von Hüftgelenkersatzimplantaten relevant sind. Diese Aspekte sind entscheidend, um die langfristige Funktionalität und Biokompatibilität der Implantate zu gewährleisten. Darüber hinaus bietet die Norm Richtlinien zur Designbewertung, die den Herstellern helfen, potentielle Risiken frühzeitig zu identifizieren und zu minimieren. Ein weiterer Vorteil der EN ISO 21535:2009 ist die detaillierte Spezifikation der Herstellungsprozesse und der Sterilisationsmethoden. Dies stellt sicher, dass die Produkte unter optimalen Bedingungen hergestellt und aufbereitet werden, was für die Sicherheit der Patienten von größter Bedeutung ist. Die Norm legt auch Anforderungen an die Verpackung und die bereitgestellten Informationen durch den Hersteller fest, die für die sichere Anwendung des Implantates notwendig sind. Insgesamt ist die EN ISO 21535:2009 von großer Relevanz für die Branche der Hüftgelenkersatzimplantate, da sie nicht nur die regulatorischen Anforderungen erfüllt, sondern auch das Vertrauen in die Qualität und Sicherheit dieser Produkte stärkt. Die klaren und präzisen Vorgaben dieser Norm fördern die Innovation und fortschrittliche Entwicklung in der Medizintechnik.
標準であるSIST EN ISO 21535:2009は、非アクティブ外科インプラントに関連する特定の要求事項を詳細に示しています。特に、股関節置換インプラントに関する要求事項が定められており、その適用範囲は非常に広範です。この標準は、股関節置換用インプラントの安全性に関する重要な基準を提供し、意図された性能、設計属性、使用材料、設計評価、製造、滅菌、包装、製造者から提供される情報、及び試験方法に関する要件を明確にしています。 この標準の強みは、股関節置換インプラントの品質と安全性を確保するための具体的かつ詳細な基準を設けている点にあります。特に、材料の選定や設計評価に関する要件は、インプラントの長期的な耐久性と患者の安全を保障します。また、滅菌及び包装の基準も、インプラントが手術時に感染を引き起こさないよう配慮されています。 さらに、ISO 21535:2007は、国際的な整合性を持ち、世界中の医療機関や製造業者が遵守すべき共通の基準を提供しています。このため、この標準は国際的な市場における競争力を向上させるだけでなく、患者の安心をも高める重要な役割を果たしています。 総じて、SIST EN ISO 21535:2009は、股関節置換インプラントに特化した包括的な基準を整備しており、その強固な要求事項は、医療業界における信頼性と安全性の向上に寄与しています。この標準は、医療用インプラント設計と製造における必須のガイドラインといえるでしょう。
The EN ISO 21535:2009 standard presents a comprehensive framework specifically tailored for non-active surgical implants, focusing on joint replacement implants, particularly hip-joint replacement implants. The scope of this standard is pivotal as it lays down the necessary specific requirements that ensure the safety and efficacy of hip joint replacements. One of the key strengths of ISO 21535:2007 is its detailed approach to intended performance, providing a clear guide for manufactures to follow throughout the design and evaluation phases. This level of specification is crucial in achieving an optimal balance between safety and performance, ultimately leading to enhanced patient outcomes. Additionally, the standard emphasizes essential design attributes and the selection of appropriate materials, which are critical for the longevity and functionality of hip-joint replacement implants. The standard also addresses various stages of the implant lifecycle, including manufacture, sterilization, and packaging. By establishing rigorous requirements in these areas, EN ISO 21535:2009 significantly reduces the risks associated with infections and other complications related to surgical implants. Moreover, the guideline's emphasis on information supplied by the manufacturer ensures that healthcare professionals are well-informed about the implants they are using, leading to better decision-making and improved patient safety. The inclusion of methods of test within the standard allows for consistent, reliable assessment processes that uphold the integrity of the hip-joint replacement implants in clinical environments. Overall, EN ISO 21535:2009 represents a vital resource within the medical device industry, aligning with global safety standards and catering specifically to the intricate needs of hip-joint replacement implants, thereby reinforcing its relevance in the current healthcare landscape.
La norme SIST EN ISO 21535:2009 constitue un document crucial pour le domaine des implants chirurgicaux non actifs, en particulier pour les implants de remplacement de la hanche. Cette norme, qui s’inspire des exigences spécifiques définies par l'ISO 21535:2007, offre un cadre clair et rigoureux concernant la conception et la fabrication de ces dispositifs médicaux essentiels. La portée de la norme englobe divers aspects critiques, garantissant non seulement la sécurité des implants de hanche, mais aussi leur performance prévue. Parmi ses points forts, la norme précise des exigences détaillées sur les attributs de conception, les matériaux utilisés, ainsi que les évaluations de conception nécessaires. Cela permet de minimiser les risques liés aux implants, en assurant une approche axée sur la sécurité optimale lors de leur utilisation. Un autre aspect majeur de la norme est son accent sur la fabrication et la stérilisation, deux processus essentiels qui garantissent que les implants peuvent être utilisés en toute sécurité dans un environnement clinique. La norme stipule également des directives sur l'emballage et les informations que le fabricant doit fournir, ce qui est crucial pour la traçabilité et la transparence vis-à-vis des utilisateurs finaux. En outre, les méthodes de test qui accompagnent cette norme permettent d’évaluer rigoureusement la conformité des implants de remplacement de la hanche aux exigences établies. Cela témoigne de l'engagement de la norme à promouvoir non seulement la sécurité, mais aussi l'efficacité des traitements chirurgicaux en matière de remplacement de la hanche. Ainsi, la norme SIST EN ISO 21535:2009 se révèle être un outil indispensable pour les fabricants et les professionnels de santé, offrant un cadre standardisé qui soutient l'innovation tout en protégeant la santé des patients. Sa pertinence est indéniable dans un secteur où la qualité et la sécurité des produits influencent directement les résultats cliniques et la qualité de vie des patients.
EN ISO 21535:2009 표준은 비활성 외과 임플란트, 특히 고관절 교체 임플란트에 대한 특정 요구사항을 규정하고 있습니다. 이 표준의 범위는 고관절 교체 임플란트의 안전성을 보장하기 위한 것으로, 의도된 성능, 설계 속성, 사용되는 재료, 설계 평가, 제조, 멸균, 포장, 제조업체의 제공 정보 및 시험 방법 등 다양한 측면을 포함하고 있습니다. 이 표준의 강점은 고관절 교체 임플란트에 대한 구체적인 요구사항을 명시하여, 품질과 안전성을 높이는 데 기여한다는 점입니다. 임플란트 설계자와 제조업체는 이 표준을 통해 보다 정확하고 일관된 기준에 따라 제품을 개발할 수 있으며, 이는 환자의 안전을 우선시하는 의료기기 분야에서 매우 중요한 요소입니다. 또한, EN ISO 21535:2009는 고관절 교체 임플란트와 관련된 글로벌 표준을 따름으로써, 국제적으로 신뢰받는 제품을 시장에 공급하는 데 도움을 줍니다. 이 표준의 적용은 제조업체가 제품의 성능 및 안정성을 지속적으로 개선하는 데 필수적인 지침을 제공하며, 모든 단계에서의 규정 준수를 통해 품질을 보장합니다. 따라서 EN ISO 21535:2009 표준은 고관절 교체 임플란트의 설계 및 제조에 있어 필수적인 기준으로 자리잡고 있으며, 안전하고 효과적인 의료 기기를 위해 꼭 필요한 문서입니다.
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