EN ISO 25539-2:2020
(Main)Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1.
Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these d
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2020)
In diesem Dokument sind Anforderungen an die Bewertung von Stentsystemen (Gefäßstents und Einführsysteme) sowie Anforderungen bezüglich der Nomenklatur, der Konstruktionsmerkmale und der vom Hersteller bereitgestellten Informationen auf der Grundlage des derzeitigen medizinischen Wissensstandes festgelegt. Eine Leitlinie für die Entwicklung von In vitro Prüfverfahren findet sich in Anhang D. Dieses Dokument ist eine Ergänzung zu ISO 14630, die allgemeine Anforderungen an die Funktion nichtaktiver chirurgischer Implantate festlegt.
ANMERKUNG 1 Aufgrund der Variationen in der Konstruktion der von diesem Dokument abgedeckten Implantate sowie in einigen Fällen aufgrund des Aufkommens neuer Typen solcher Implantate stehen nicht immer annehmbare genormte In vitro Prüfungen und klinische Ergebnisse zur Verfügung. Mit dem Verfügbarwerden weiterer wissenschaftlicher und klinischer Daten wird eine entsprechende Überarbeitung dieses Dokuments notwendig.
Dieses Dokument bezieht sich auf Gefäßstents und Gefäßgerüste (z. B. absorbierbare Gefäßgerüste), die zur Behandlung vaskulärer Stenosen oder sonstiger vaskulärer Anomalien oder Erkrankungen eingesetzt werden. Einige der Anforderungen gelten spezifisch für die endovaskuläre Behandlung arterieller Stenosen. Die Verwendung von Stentsystemen über die Behandlung arterieller Stenosen (z. B. Venen-Stenting) hinaus fällt zwar in den Anwendungsbereich dieses Dokuments, jedoch werden für diese Anwendungen keine umfassenden Anforderungen und Prüfungen beschrieben. Ebenso fallen bestimmte Stentkonfigurationen (z. B. Bifurkationsstents) in den Anwendungsbereich dieser Norm, jedoch werden für diese Implantate keine umfassenden Anforderungen und Prüfungen beschrieben.
Stents, die in Kombination mit einer endovaskulären Prothese verwendet werden, um die Behandlung einer Läsion zu vervollständigen, darunter überbrückende Stents (z. B. Stents, die nach Einführen einer fenestrierten endovaskulären Prothese in die Nierenarterien platziert werden), fallen in den Anwendungsbereich dieses Dokuments, Prüfverfahren werden für die Kombination jedoch nicht beschrieben. ISO 25539 1 enthält Informationen für vorklinische In vivo und klinische Bewertungen solcher Stents.
Gefäßstents mit Oberflächenmodifikationen, wie zum Beispiel Arzneimittel und/oder andere Beschichtungen, fallen in den Anwendungsbereich dieses Dokuments. Stents, die mit Materialien ummantelt sind, die die Durchlässigkeit des nicht ummantelten Stents signifikant verändern (z. B. indem sie die stentfreie Oberfläche bedecken), liegen im Anwendungsbereich von ISO 25539 1. Die Konstruktion oder der vorgesehene Verwendungszweck des Stents könnte die Anwendung funktionaler Anforderungen sowohl der ISO 25539 1 als auch dieses Dokuments erforderlich machen (z. B. Stents, die in Kombination mit endovaskulären Prothesen verwendet werden, Stents, die zur Behandlung von Aortenaneurysmen verwendet werden).
[...]
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses vasculaires (ISO 25539-2:2020)
Le présent document spécifie les exigences relatives à l'évaluation des ensembles stent/dispositif d'injection (stents vasculaires et systèmes d'injection) et les exigences relatives à la nomenclature, aux caractéristiques de conception et aux informations fournies par le fabricant, sur la base des connaissances médicales actuelles. Les recommandations relatives à l'élaboration des méthodes d'essai in vitro figurent à l'Annexe D. Le présent document complète l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
NOTE 1 En raison des variantes de conception parmi les implants traités dans le présent document et en raison, dans certains cas, de l'émergence de nouveaux types de tels implants, des essais in vitro normalisés et des résultats cliniques acceptables ne sont pas toujours disponibles. Lorsque de nouvelles données scientifiques et cliniques seront disponibles, il sera nécessaire de procéder à une révision appropriée du présent document.
Le présent document s'applique aux stents vasculaires et aux supports vasculaires (par exemple, supports vasculaires absorbables) utilisés pour le traitement des sténoses vasculaires ou d'autres troubles ou pathologies vasculaires. Certaines des exigences sont spécifiques au traitement endovasculaire des sténoses artérielles. Bien que les utilisations d'ensembles stent/dispositif d'injection autres que le traitement des sténoses artérielles (par exemple, implantation de stents veineux) entrent dans le domaine d'application du présent document, les exigences et essais complets ne sont pas décrits pour de telles utilisations. De la même manière, les configurations de stents spécifiques (par exemple, stents de bifurcation) entrent dans le domaine d'application du présent document, mais les exigences et essais complets ne sont pas décrits pour ces dispositifs.
Les stents utilisés en combinaison avec une prothèse endovasculaire afin de compléter le traitement d'une lésion, y compris les stents de pontage (par exemple, stents placés dans les artères rénales après la pose d'une prothèse endovasculaire fenêtrée), entrent dans le domaine d'application du présent document, mais les méthodes d'essai ne sont pas décrites pour l'ensemble combiné. L'ISO 25539-1 fournit également des informations pertinentes pour les évaluations précliniques in vivo et les évaluations cliniques de ces stents.
Les stents vasculaires modifiés en surface, avec par exemple un enrobage médicamenteux et/ou d'autres formes de revêtements, sont couverts par le présent document. Les stents recouverts de matériaux qui modifient sensiblement l'étanchéité du stent nu (par exemple, en recouvrant la surface du vaisseau sans contact avec le stent) sont compris dans le domaine d'application de l'ISO 25539-1. La conception ou l'utilisation prévue du stent peut imposer la nécessité de prendre en compte les exigences fonctionnelles identifiées dans l'ISO 25539-1 et dans le présent document (par exemple, dans le cas de stents utilisés conjointement avec des prothèses endovasculaires ou de stents utilisés pour le traitement d'anévrismes aortiques).
Les ballonnets intégrés à l'ensemble stent/dispositif d'injection sont couverts par le présent document. Le présent document fournit des exigences allant au-delà de celles de l'ISO 10555-4, spécifiques à l'utilisation de ballonnets avec des stents vasculaires.
Les techniques et les dispositifs utilisés avant l'introduction du stent vasculaire, te
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 2. del: Žilne opornice (stent) (ISO 25539-2:2020)
General Information
Relations
Overview
EN ISO 25539-2:2020 (ISO 25539-2:2020) specifies requirements for the evaluation of vascular stents and complete stent systems (stents plus delivery systems). It covers nomenclature, design attributes, materials, performance expectations and information that manufacturers must supply, based on current medical knowledge. The standard is supplemental to ISO 14630 (general requirements for non‑active surgical implants) and provides guidance for in vitro test-method development (Annex D). It applies to metallic and absorbable stents, scaffolds, stents with surface modifications (including drug coatings), and balloons integral to stent systems - while noting that for many novel designs or specific uses (e.g., some venous, bifurcation stents, combination devices) comprehensive testing guidance may be limited.
Key topics and technical requirements
The document addresses practical and technical topics important for design, evaluation and regulatory compliance:
- Scope and device classification: definitions, type of stent, intended clinical use and size/configuration designation.
- Design attributes: mechanical and functional attributes for stent and delivery systems, coatings, absorbable materials and drug‑eluting features.
- Materials: selection, biocompatibility considerations and implications for performance.
- Design evaluation and testing:
- Bench and analytical tests for stent and delivery system performance
- Conditioning, sampling and reporting requirements
- Special sections for absorbable stents, coatings and drug‑containing devices
- Preclinical in vivo and clinical evaluation: objectives, protocol considerations, data acquisition and reporting.
- Post‑market surveillance, manufacturing, sterilization and packaging: requirements for sterile products, residuals, labelling and information for users.
- Annexes: informative guidance linking testing to failure modes, clinical/device effects of failure, and test methods (Annex D).
Practical applications and who uses this standard
ISO 25539-2 is essential for:
- Medical device manufacturers designing, testing or marketing vascular stents, scaffolds and stent delivery systems.
- Design engineers developing stent geometry, coatings or absorbable materials.
- Regulatory and quality teams preparing technical files, conformity assessments or CE/market submissions in jurisdictions recognizing EN ISO adoption.
- Test laboratories and contract research organizations (CROs) performing bench, preclinical and clinical evaluation.
- Clinical teams and procurement seeking clarity on device performance claims, labelling and intended use.
Use this standard to structure design verification, risk‑based test plans, preclinical strategies and device labelling to meet industry and regulatory expectations for endovascular devices.
Related standards
- ISO 14630 - Non‑active surgical implants (general requirements)
- ISO 25539-1 - Endovascular prostheses (related evaluation aspects)
- ISO 10555-4 - Balloons for use with vascular stents (balloon‑specific tests)
- ISO 12417-1 - Vascular device‑drug combination products (device‑drug combinations)
Keywords: ISO 25539-2, vascular stents, stent systems, endovascular devices, design evaluation, bench testing, drug‑eluting stents, absorbable stents, regulatory compliance.
Frequently Asked Questions
EN ISO 25539-2:2020 is a standard published by the European Committee for Standardization (CEN). Its full title is "Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)". This standard covers: This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary. This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices. Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents. Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms). Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents. This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices. Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices. Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices. NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1. Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these d
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary. This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this document, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices. Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this document, but test methods are not described for the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical evaluations of such stents. Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this document. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms). Balloons integral to the stent system are within the scope of this document. This document provides requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with vascular stents. This document is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices. Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow diverters are within the scope of this document, but comprehensive requirements and testing are not described for these devices. Although drug-eluting stents are within the scope of this document, this document is not comprehensive with respect to the drug-eluting properties of these devices. NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1. Although absorbable stents and stents with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these d
EN ISO 25539-2:2020 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 25539-2:2020 has the following relationships with other standards: It is inter standard links to EN ISO 25539-2:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 25539-2:2020 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 25539-2:2020 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-november-2020
Nadomešča:
SIST EN ISO 25539-2:2013
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 2. del: Žilne opornice
(stent) (ISO 25539-2:2020)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-
2:2020)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539
-2:2020)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses
vasculaires (ISO 25539-2:2020)
Ta slovenski standard je istoveten z: EN ISO 25539-2:2020
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 25539-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 25539-2:2012
English Version
Cardiovascular implants - Endovascular devices - Part 2:
Vascular stents (ISO 25539-2:2020)
Implants cardiovasculaires - Dispositifs Kardiovaskuläre Implantate - Endovaskuläre
endovasculaires - Partie 2: Endoprothèses vasculaires Implantate - Teil 2: Gefäßstents (ISO 25539-2:2020)
(ISO 25539-2:2020)
This European Standard was approved by CEN on 20 August 2020.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-2:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 25539-2:2020) 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 March 2021, and conflicting national standards shall
be withdrawn at the latest by March 2021.
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 25539-2:2012.
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 25539-2:2020 has been approved by CEN as EN ISO 25539-2:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 25539-2
Third edition
2020-09
Cardiovascular implants —
Endovascular devices —
Part 2:
Vascular stents
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 2: Endoprothèses vasculaires
Reference number
ISO 25539-2:2020(E)
©
ISO 2020
ISO 25539-2:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
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Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 25539-2:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements for stent systems . 6
4.1 General . 6
4.2 Type of stent . 6
4.3 Materials of construction for stent system . 6
4.4 Configuration and size designation for stents and stent systems . 6
4.5 Intended clinical use designation . 7
4.6 Balloon designation . 8
5 Intended performance . 8
6 Design attributes . 8
6.1 General . 8
6.2 Stent system . 8
6.3 Stent. 8
6.4 Stent system and stent . 9
6.5 Coating on delivery system or stent . 9
6.6 Coating on stent . 9
6.7 Absorbable stent or coating . 9
6.8 Drug-eluting stent .10
7 Materials .10
8 Design evaluation .10
8.1 General .10
8.2 Sampling .11
8.3 Conditioning of test samples .12
8.4 Reporting .12
8.5 Bench and analytical tests .13
8.5.1 Stent system and delivery system .13
8.5.2 Stent .16
8.5.3 Absorbable stents and stents containing an absorbable coating .22
8.5.4 Coating on a delivery system .22
8.5.5 Coating on a stent .22
8.5.6 Drug-containing stent.22
8.6 Preclinical in vivo evaluation .23
8.6.1 Purpose .23
8.6.2 Specific aims .23
8.6.3 Protocol considerations .24
8.6.4 Data acquisition .24
8.6.5 Test report and additional information .26
8.7 Clinical evaluation .27
8.7.1 Purpose .27
8.7.2 Specific aims .27
8.7.3 Protocol considerations .28
8.7.4 Data acquisition .29
8.7.5 Final report .31
9 Post-market surveillance .32
10 Manufacturing .32
11 Sterilization .32
ISO 25539-2:2020(E)
11.1 Products supplied sterile .32
11.2 Sterilization residuals .33
12 Packaging .33
12.1 General .33
12.1.1 General.33
12.1.2 Unit container .33
12.1.3 Outer container .33
12.1.4 Shipping container .33
12.1.5 Maintenance of sterility in transit .33
12.2 Labelling .33
12.2.1 Container label .33
12.2.2 Stents without delivery systems .33
12.2.3 Stent systems (stents with delivery system) .34
12.2.4 Record label . .34
12.3 Information supplied by the manufacturer .34
12.3.1 General.34
12.3.2 Information and instructions for use for stents and/or stent systems .35
Annex A (informative) Relationship between testing requirements, device attributes, and
potential failure modes and guidance for the creation of a device evaluation strategy .36
Annex B (informative) Description of clinical effects of failure .53
Annex C (informative) Description of device effects of failure .56
Annex D (informative) Test methods .58
Bibliography .113
iv © ISO 2020 – All rights reserved
ISO 25539-2:2020(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 of the voluntary nature of standards, 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee
for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance
with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 25539-2:2012), which has been
technically revised.
The main changes compared to the previous edition are updates to the testing and clinical use of
vascular stents as well as improved consistency in nomenclature and reporting requirements.
A list of all parts in the ISO 25539 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
ISO 25539-2:2020(E)
Introduction
This document was prepared to provide minimum requirements for vascular stents. The rationale
for the requirements for bench tests and analyses to assess device performance, guidance on the
identification of appropriate testing to evaluate a specific device design, and guidance for developing
test methods are provided in informative annexes. Further clarification of terminology is provided in
additional informative annexes.
This document has been updated to reflect current knowledge regarding the testing and clinical use of
vascular stents, reflected in modifications to the requirements in the main body and in the guidance for
developing test methods in Annex D. In addition, revisions have been made to improve consistency in
nomenclature and reporting and to enhance the utility of this document.
Requirements particular to the evaluation of specific characteristics of stents (e.g. coatings, drug-
elution, absorption) are incorporated by reference to appropriate standards. However, not all tests
listed in the referenced standards are applicable to vascular stents. Only tests that address the design
attributes specified in Clause 6 are required for compliance to this document.
This revised document introduces methodology to identify appropriate testing and analyses for a
specific vascular stent, designated as the device evaluation strategy. The requirement regarding the
device evaluation strategy is in the main body. Annex A provides guidance for developing a focused
device evaluation strategy table that is specific to the unique characteristics of a device, device design
modifications, or changes in intended use. Annex A also provides guidance for the development of a
comprehensive device evaluation strategy table that may be used when it is not sufficient to focus only
on the unique characteristics or changes.
NOTE ISO 25539-1:2017 includes tables that can be used to justify the testing needed for device design
modifications and changes in intended use in Annex A. In this document, this concept is called a focused device
evaluation strategy table and can be applied to a new device as well as device design modifications or changes in
the intended use.
The other significant modifications in the requirements include the addition of non-radial durability
testing, with guidance on the selection of appropriate testing, and specific requirements for testing
to evaluate patency-related characteristics. Guidance for the development of appropriate tests to meet
these requirements is included in Annex D.
The guidance on the development of methods to address the requirement for evaluating fatigue and
durability through computational analyses has been modified significantly to include recommendations
regarding verification of the solution and validation of the computational model, as well as reporting.
The guidance on the model development for simulated use has also been significantly revised to
improve the clinical relevance of this testing.
The specific requirements to evaluate pushability, flexibility, torquability, trackability, and deployment
accuracy of a stent system have been removed and incorporated within the simulated use evaluation
requirement to better reflect how these attributes are evaluated. Similarly, the requirement to evaluate
tubing tensile strength has been removed and incorporated within the evaluation of tensile bond
strength.
In addition to modifications to specific design evaluation requirements, guidance has been provided
regarding the assessment of the acceptability of test results. When the requirement is to quantitatively
appraise or analyse a parameter, test results generally may be compared to a quantitative value (i.e.
acceptance criteria). For characterization tests it is appropriate to provide an explanation of the
relevance of the results. Additionally, some testing may include comparison to test data or existing data
from a previously evaluated device.
For design evaluation, requirements regarding sampling, conditioning of test samples, and reporting
have been incorporated in the main body. Guidance on these elements of testing and documentation
were previously only included in Annex D.
vi © ISO 2020 – All rights reserved
ISO 25539-2:2020(E)
The revisions to the annexes to this document are as follows:
Annex of ISO 25539-2:2012 Revision
Annex A — Attributes of endovascular devic- Annex A now includes the relationship between testing
es — Vascular stents — Technical and clinical requirements, device attributes, and potential failure
considerations modes and guidance for the creation of a device evaluation
strategy.
Annex B — Bench and analytical tests The list of tests is included in Table D.1.
Annex B now includes a description of potential clinical
effects of failure. Effects of failure for stents used with end-
ovascular prostheses are included.
Annex C — Definitions of reportable clinical The term “reportable” clinical events is no longer used in
events this document.
Annex C now includes a description of potential device
effects of failure. Effects of failure for stents used with end-
ovascular prostheses are included.
Annex D — Test methods This edition incorporates the sample equations as a supple-
ment to the radial fatigue durability test from ISO 25539-
2:2012, Annex E in Annex D.
Annex E — Supplement to the radial fatigue and There is no longer an Annex E as the sample equations as a
durability test analytical approach supplement to the fatigue durability test have been incorpo-
rated in Annex D.
It is recognized by this ISO committee that many stent systems have been shown to be safe and effective
in clinical use. This update is not intended to require additional evaluation of these devices to remain
in compliance with this document as the testing would not provide useful information regarding the
expected clinical performance of the device. Manufacturers may rely on historical data gathered under
the guidance of the previous edition of ISO 25539-2. Similarly, for device modifications or changes in
intended clinical use, this update is not intended to require additional evaluation of any aspects of the
device that are not expected to change clinical performance.
NOTE The relationship between testing requirements, device attributes, and potential failure modes is
provided in Clause A.1. Clause A.1 also provides general information regarding device evaluation strategies.
Tables A.2 and A.3 provide the rationale for the requirements specified in this document for bench tests and
analyses to assess device performance. An explanation of the table headings for A.2 and A.3 are described in
Table A.1.
Guidance for the creation of a device-specific evaluation strategy is provided in Clause A.2. Two approaches to
create a device-specific evaluation strategy are provided: 1) focused device evaluation strategy in A.2.1; and 2)
comprehensive device evaluation strategy in A.2.2.
Annex B provides a description of the potential clinical effects of failure identified in Annex A.
Annex C provides a description of the potential device effects of failure identified in Annex A.
Additional descriptions of clinical and device effects of failure are included in Annexes B and C, respectively.
Annex D provides information to consider in developing appropriate bench test and analytical methods.
INTERNATIONAL STANDARD ISO 25539-2:2020(E)
Cardiovascular implants — Endovascular devices —
Part 2:
Vascular stents
1 Scope
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery
systems) and requirements with respect to nomenclature, design attributes and information supplied
by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro
test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies
general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to
the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not
always available. As further scientific and clinical data become available, appropriate revision of this document
will be necessary.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular
scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of
the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent
systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this
document, comprehensive requirements and testing are not described for these uses. Similarly, specific
stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and
testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion,
including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated
endovascular prosthesis), are within the scope of this document, but test methods are not described for
the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical
evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the
scope of this document. Stents covered with materials that significantly modify the permeability of the
uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The
stent design or intended use might dictate the need to address functional requirements identified in
both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses,
stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides
requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with
vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular
stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow
diverters are within the scope of this document, but comprehensive requirements and testing are not
described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive
with respect to the drug-eluting properties of these devices.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1.
ISO 25539-2:2020(E)
Although absorbable stents and stents with absorbable coatings are within the scope of this document,
this document is not comprehensive with respect to the absorbable properties of these devices.
NOTE 3 Absorbable implants are within the scope of ISO/TS 17137.
Although coated stents and coated stent systems are within the scope of this document, this document
is not comprehensive with respect to coatings.
NOTE 4 Some coating properties are within the scope of ISO 17327-1.
This document does not address the requirements for, and the evaluation of, viable tissues and non-
viable biologic materials used in the construction of vascular stents.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993 (all parts), Biological evaluation of medical devices — Part 1: Evaluation and testing within a
risk management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
ISO 14630, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
2 © ISO 2020 – All rights reserved
ISO 25539-2:2020(E)
3.1
adverse event
unfavorable change in health that occurs in a subject who participates in a study while receiving the
treatment or within a specified time after receiving treatment
Note 1 to entry: For the purpose of this document, clinical effects of failure are a subset of adverse events and are
described separately.
Note 2 to entry: Adverse events are categorized by the system affected (e.g. cardiac, vascular, respiratory,
neurological, renal, gastro-intestinal) and the severity of the event.
3.2
post-dilation
use of a balloon to facilitate the complete deployment (or expansion) of a self-expanding stent (3.22.9)
3.3
bridging stent
vascular stent used in combination with an endovascular prosthesis to complete the treatment of a lesion
Note 1 to entry: See 3.22 for vascular stent.
3.4
clinical effect of failure
specific clinical observations potentially associated with device failures
Note 1 to entry: Clinical effects of failure are described in Annex B.
3.5
coating
additional layer of organic or inorganic material, other than living cells, on the surface of a substrate
that modifies its surface properties
Note 1 to entry: This coating can be intended to be permanent or temporary and can be applied to the external
and/or internal surface.
3.5.1
absorbable coating
coating (3.5) that is intended to be absorbed
Note 1 to entry: Drugs are excluded from this definition of absorbable coatings.
3.6
delivery system
system or mechanism used to deliver the stent to the targeted position and to deploy the stent
Note 1 to entry: The delivery system is removed after stent placement. Examples of delivery systems include
balloon catheters or mechanically activated systems.
3.7
determine
appraise or analyse quantitatively
Note 1 to entry: Also see evaluate (3.14).
3.8
device effects of failure
consequence to the device potentially associated with device failures
Note 1 to entry: Device effects of failure are described in Annex C.
ISO 25539-2:2020(E)
3.9
device evaluation strategy
rationale for the testing selected for a specific stent system, based on the requirements of the device
design and potential failure modes
3.10
comprehensive device evaluation strategy table
optional communication tool to present the device evaluation strategy for a specific stent system that
addresses all attributes and failure modes (3.15)
3.11
focused device evaluation strategy table
optional communication tool to present the device evaluation strategy for a specific stent system that
focuses on the unique characteristics of the device design or procedure and unique aspects of the
intended use
3.12
dogboning
dumbbell-shaped balloon observed when the unconstrained ends of the balloon expand beyond the
dilated stent outer diameter
3.13
drug
active pharmaceutical ingredient [pharmacologically active (drug or medicinal) substance used as
a raw material, which is coated on, bound to, or incorporated into the device to achieve an ancillary
device function (e.g. minimizing vascular restenosis)] in its final form for administration to the patient
(e.g. tablet, solution, spray), that is intended to prevent, diagnose, or treat disease and that achieves its
principal intended action in or on the body by pharmacological, immunological, or metabolic means
3.14
evaluate
qualitatively appraise or analyse
Note 1 to entry: Also see determine (3.7).
3.15
failure mode
difficulty or failure of the stent system that can be encountered (hazards) in preclinical in vivo or
clinical use of a vascular stent and could result in consequences (harm) to the subject
3.16
nominal diameter
primary labelled diameter of the stent
3.17
rated burst pressure
RBP
pressure at which a balloon would not be expected to burst based on appropriate confidence and
reliability
3.18
stent configuration
stent shape and geometry
Note 1 to entry: Examples include cylindrical, tapered, flared, coiled, segmented, bifurcated, articulated, closed
cell, open cell.
4 © ISO 2020 – All rights reserved
ISO 25539-2:2020(E)
3.19
stent outer surface area
maximum contact area between the stent and the vessel
Note 1 to entry: Although the entire stent may not contact the vessel wall depending on the conformance to the
vessel wall and the intended clinical use (e.g. for treatment of aneurysms), the stent outer surface area would
include the maximum potential area along the entire length of the stent.
3.20
stent-free surface area
percentage of surface area of cylinder formed by the implant frame, which is not covered by implant
material
3.21
stent system
vascular stent and its delivery system (3.6)
Note 1 to entry: If a stent is to be mounted on a delivery balloon, as specified in the instructions for use (IFU),
the balloon catheter is not considered part of the stent system with respect to the design requirements and
evaluation specified in this document, with the exception of the simulated use, in vivo animal, and clinical study
requirements. The balloon catheter would be part of the stent system for testing that evaluates the stent only
where the stent system is needed to conduct the testing.
3.22
vascular stent
vascular scaffold
stent
implant
transluminally placed balloon-expandable or self-expanding implant intended to maintain or restore
vessel patency or function
Note 1 to entry: Stents can have surface modifications, such as drug and/or other coatings.
Note 2 to entry: The requirements of this document include vascular stents and vascular scaffolds (e.g. absorbable
vascular scaffolds) and both are covered by the term stent for simplicity.
Note 3 to entry: The following stent types are within the scope of this document.
3.22.1
absorbable stent
stent that is designed to be a temporary structure without requiring explantation
3.22.2
articulated stent
stent constructed of segments with distinct connections
3.22.3
balloon-expandable stent
stent where the diameter is increased from its pre-deployed size to its deployed size with the aid of
a balloon
3.22.4
bare stent
stent without a coating or covering
Note 1 to entry: Bare stents can be constructed of a single or multiple materials.
Note 2 to entry: Bare stents can contain a metal oxide layer.
ISO 25539-2:2020(E)
3.22.5
coated stent
stent with a surface layer of an additional material(s) that does not provide significant (e.g. more than
5 %) structural support or appreciably reduce the permeability of the bare stent [e.g. by covering the
stent-free surface area (3.20)]
Note 1 to entry: Stents containing only a metal oxide layer are not considered a coated stent for the purposes of
this document.
3.22.6
covered stent
stent covered with an additional material(s) that appreciably reduces permeability of the bare stent
[e.g. by covering the stent-free surface area (3.20)]
Note 1 to entry: Covered stents are within the scope of ISO 25539-1. The stent design might dictate the need to
address functional requirements identified in both ISO 25539-1 and this document.
3.22.7
drug-containing stent
stent that has a drug coating that is not intended to release the drug
Note 1 to entry: For the purposes of this document, drug-eluting refers to both drug-eluting and dr
...
표준 EN ISO 25539-2:2020은 혈관 스텐트 및 배달 시스템의 평가를 위한 요구 사항을 명시하고 있습니다. 이 문서는 혈관 협착증이나 기타 혈관 이상을 치료하는 데 사용되는 혈관 스텐트 및 혈관 스캐폴드의 설계 속성, 명명법 및 제조업체가 제공하는 정보에 대한 요구 사항을 포함합니다. 또한, Annex D에서는 인 비트로 테스트 방법 개발을 위한 지침이 포함되어 있어 실험 실무에 도움이 됩니다. 이 표준의 강점 중 하나는 의료 지식의 현재 상태에 기반하여 실질적이고 명확한 요구 사항을 설정하고 있다는 점입니다. 혈관 스텐트는 상당한 변형이 있을 수 있으며, 이 표준은 그러한 변형을 반영하여 다양한 종류의 스텐트를 포괄적으로 다룹니다. 특히, 이 문서는 동맥 협착증의 내과적 치료에 특정 요구 사항을 제시하며, 이는 임상 적용에 매우 중요한 요소입니다. EN ISO 25539-2:2020의 적용 범위는 스텐트 시스템에 그치지 않고, 약물 또는 기타 코팅이 있는 혈관 스텐트와 같은 표면 수정 스텐트도 포함됩니다. 이는 복합적 치료가 필요한 경우 스텐트 설계 및 용도에 따라 기능적 요구 사항을 해결하는 데 기여할 수 있습니다. 또한, 이 문서는 ISO 10555-4의 요구 사항을 넘어서는 요건을 제공하여 혈관 스텐트와 함께 사용되는 풍선의 사용에 대한 구체적 지침도 포함하고 있습니다. 이 표준은 의약품 방출 스텐트와 같은 혁신적인 장비도 포괄하지만, 특정 약물 방출 특성에 대한 포괄적인 규정은 제공하지 않고 있습니다. 이와 관련하여 흡수성 스텐트 및 흡수성 코팅이 있는 스텐트도 같은 맥락에서 다루어지지만, 이들에 대한 완전한 요구 사항이 설명되어 있지 않습니다. 종합적으로 볼 때, EN ISO 25539-2:2020 표준은 혈관 스텐트의 성능과 안전성을 보장하기 위해 필요한 평가 기준을 제시하며, 혈관 장치 및 약물 조합 제품에 대한 요구 사항이 ISO 12417-1의 범위 안에 있음을 확인하여 의료 기기의 발전에 기여합니다. 다양한 임상 상황을 고려한 표준은 혈관 치료 장비의 품질과 신뢰성을 높이는 데 중요한 역할을 합니다.
Le document SIST EN ISO 25539-2:2020 spécifie des exigences cruciales pour l’évaluation des systèmes de stents vasculaires et des systèmes de livraison associés. Cette norme est d'une importance capitale dans le domaine des implants cardiovasculaires, car elle offre un cadre structuré pour la nomenclature, les attributs de conception et les informations à fournir par le fabricant. La pertinence de cette norme découle de sa capacité à intégrer les connaissances médicales actuelles pour garantir la sécurité et l'efficacité des dispositifs endovasculaires. Parmi ses points forts, la norme comprend des orientations pour le développement de méthodes de test in vitro, ce qui est essentiel pour améliorer la validité des évaluations cliniques des stents. Elle couvre un large éventail d'applications, y compris les stents vasculaires et les échafaudages vasculaires utilisés pour traiter des sténoses ou d'autres anomalies vasculaires. De plus, cette norme s'adapte aux variations de conception des implants en permettant une certaine flexibilité dans les tests, tout en soulignant la nécessité d'évoluer avec l'acquisition de nouvelles données scientifiques et cliniques. La norme est également pertinente pour les stents présentant des modifications de surface, telles que les revêtements médicamenteux, tout en intégrant des exigences supplémentaires concernant l'utilisation des ballons associés aux systèmes de stents. Cela apporte une valeur ajoutée en garantissant que tous les aspects du design et de la fonctionnalité des stents sont pris en compte, ce qui peut potentiellement améliorer les résultats cliniques. Bien qu'elle ne couvre pas de manière exhaustive l'ensemble des configurations et applications possibles, comme les stents utilisés dans le traitement des sténoses veineuses ou les stents à élution de médicaments, elle fournit néanmoins une base solide pour les développements futurs dans le domaine des dispositifs endovasculaires. La prise en compte des dispositifs de combinaison de médicaments et des stents absorbables montre également une capacité d'anticipation des besoins évolutifs de la médecine cardiovasculaire. En résumé, le SIST EN ISO 25539-2:2020 est une norme essentielle qui non seulement fixe des exigences claires et structurées pour les systèmes de stents vasculaires, mais qui est également adaptable aux innovations et aux nouvelles découvertes dans le secteur médical. Elle jouera sans aucun doute un rôle fondamental dans l’amélioration et la standardisation des dispositifs endovasculaires, garantissant ainsi une meilleure sécurité pour les patients.
The EN ISO 25539-2:2020 standard addresses the evaluation of vascular stents and their delivery systems, providing a comprehensive guideline that is vital for manufacturers and healthcare professionals involved in cardiovascular implants. The scope of this standard encompasses various aspects, including nomenclature, design attributes, and essential information that manufacturers are required to furnish. This systematic approach ensures that stent systems are evaluated based on current medical knowledge, which enhances the reliability and safety of these devices. One of the primary strengths of ISO 25539-2:2020 is that it constitutes a supplemental document to ISO 14630, which lays down general performance requirements for non-active surgical implants. This relationship ensures that the unique considerations associated with vascular stents are properly addressed while still maintaining a consistent framework for comparisons with other implant types. The standard also includes guidelines for the development of in vitro test methods in Annex D, which is crucial given the variability of stent designs and the emergence of novel types. These guidelines are essential for manufacturers to create robust testing frameworks that can validate the efficacy and safety of different stent designs. Despite the challenges in creating standardized tests for all design variations, this document provides a foundational basis for ongoing research and development efforts. Of particular relevance is the inclusion of vascular scaffolds, such as absorbable vascular scaffolds, which addresses the evolving landscape of cardiovascular treatment options. While the standard is comprehensive regarding vascular stenoses, it recognizes that specific configurations, such as bifurcation stents, require further exploration and detailed requirements. Moreover, the inclusion of drug-eluting stents and those with surface modifications signifies the standard's responsiveness to contemporary advances in stenting technology. Although it does not cover every detail regarding their drug-eluting properties, it ensures that these innovations are considered within the broader framework of vascular devices. Another strength of the EN ISO 25539-2:2020 standard is the clear delineation of components within its scope. This ranges from integral balloons to tacking devices and coil supporting devices. This holistic view helps ensure that all relevant technologies are assessed for safety and effectiveness, addressing the complexities involved in endovascular treatments. Overall, the EN ISO 25539-2:2020 standard is a critical document that provides valuable guidelines for the evaluation of vascular stents. Its emphasis on design, nomenclature, and the importance of continuous revision in light of new scientific data highlights its dynamic relevance in the field of cardiovascular implants.
Die Norm EN ISO 25539-2:2020 widmet sich der Standardisierung von kardiovaskulären Implantaten, speziell von endovaskulären Geräten, und fokussiert sich auf vaskuläre Stents. Ihr Umfang beinhaltet entscheidende Anforderungen für die Evaluierung von Stentsystemen und deren Liefermethoden basierend auf dem aktuellen medizinischen Wissen. Die Norm legt Anforderungen hinsichtlich Nomenklatur, Designeigenschaften und Informationen fest, die vom Hersteller bereitgestellt werden müssen. Ein herausragendes Merkmal dieser Norm ist, dass sie den Entwicklern von Stents eine klare Richtlinie zur Verfügung stellt, welche Aspekte bei der Gestaltung und Prüfung von vascular stents berücksichtigt werden sollten. Insbesondere die Aufnahme von Leitlinien zur Entwicklung von in vitro-Testmethoden im Anhang D stellt sicher, dass die Norm sowohl Forschung als auch klinische Anwendungen fördert. Die Relevanz dieser Norm zeigt sich in ihrer Anwendbarkeit auf eine Vielzahl von Anwendungsfällen, wie die Behandlung von vaskulären Stenosen oder anderen vaskulären Anomalien. Auch wenn einige spezifische Anforderungen für die endovaskuläre Behandlung von arteriellen Stenosen definiert sind, ist die Norm flexibel genug, um verschiedene Stentkonfigurationen, wie Bifurkationsstents oder absorbierbare vaskuläre Gerüste, abzudecken. Die Norm umfasst zudem Stents, die mit einem Endoprothesen-System kombiniert werden, und solche mit Oberflächenmodifikationen, wie beschichtete Stents. Diese Flexibilität spiegelt sich in der Möglichkeit wider, dass die Entwicklung und der Einsatz von Stents auch weiterhin von weiteren klinischen Daten abhängig sind, was die Norm zukunftssicher macht. Ein weiteres positives Element ist, dass die Norm Anforderungen an Ballons enthält, die integral zum Stentsystem gehören, und über die Anforderungen der ISO 10555-4 hinausgeht. Dies erleichtert die Entwicklung von umfassenden Lösungen, die auf vaskuläre Stents zugeschnitten sind. Zusammengefasst bietet die EN ISO 25539-2:2020 eine fundierte Grundlage für die Sicherheits- und Leistungsbewertung von vaskulären Stents. Ihre vielfältigen Anwendungsbereiche und klaren Anforderungen stellen sicher, dass die Norm nicht nur heute, sondern auch in Zukunft relevant bleibt, während sie auf die Herausforderungen im Bereich der kardiovaskulären Implantate eingeht.
EN ISO 25539-2:2020は、血管ステントやデリバリーシステムを含むステントシステムの評価に関する要件を明確に規定しています。この標準文書は、現在の医療知識に基づいて、製造者が提供する情報、設計属性、命名法に関する要件を定めており、特に血管狭窄やその他の血管異常を治療するために使用される血管ステント及び血管スキャフォールドの審査に関連しています。 この標準の特筆すべき強みは、血管ステントの設計や機能に関連する基準を提供し、医療の革新に則った評価方法を示している点です。特に、血管ステントが腎動脈に展開される際の橋渡しステントのような独自の使用法も考慮されているため、さまざまな治療シナリオに対応可能です。また、薬剤溶出型ステントや表面改質を施したステントに対するガイドラインも提供されており、医療機器としての包括的な評価を促進します。 文書は、ISO 14630の一般的な要件に補足的であるため、血管ステントの性能において高い信頼性を保持しています。付録Dに含まれるin vitro試験方法の開発に関するガイダンスは、臨床応用に向けた実践的な指針を提供し、研究や開発における新しい知見を反映させるための基礎を築いています。 ただし、特定のデバイス構成（例：分岐ステント）や血管ステントの他の適用（例：静脈ステンティング）に関しては、包括的な要件や試験が詳細に説明されていない点に留意する必要があります。また、新たな科学的および臨床データに基づいて、この文書の適切な改訂が求められる可能性があることも強調されています。 血管ステントにおけるバルーンの使用についても、新たに規定された要件があり、その使用状況に応じた適切な基準が設けられています。全体として、EN ISO 25539-2:2020は、現在の医療技術とその発展を反映した意味で、高い関連性を持ち、人々の健康を支えるための基盤を構築しています。
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