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CEN

prEN ISO 25539-3

(Main)

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023)

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023)

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 3: Hohlvenenfilter (ISO/DIS 25539-3:2023)

Dieses Dokument legt auf der Grundlage des derzeitigen medizinischen Wissensstandes Anforderungen an die Bewertung von Hohlvenenfiltersystemen (Filter und Einführsysteme) und Anforderungen bezüglich der Nomenklatur, der Implantatmerkmale und der vom Hersteller bereitzustellenden Informationen fest. In Anhang D ist ein Leitfaden für die Entwicklung von In-vitro-Prüfverfahren enthalten. Dieses Dokument ergänzt ISO 14630, die die allgemeinen Anforderungen an die Funktion nicht-aktiver chirurgischer Implantate festlegt.
ANMERKUNG 1   Aufgrund der Unterschiede in der Konstruktion von Implantaten, die von diesem Dokument erfasst sind, und in einigen Fällen durch das Erscheinen neuartiger Typen derartiger Implantate stehen nicht immer brauchbare genormte In-vitro-Prüfungen und klinische Ergebnisse zur Verfügung. Im Zuge der Bereitstellung weiterer wissenschaftlicher und klinischer Daten wird eine angemessene Überarbeitung dieses Dokuments notwendig werden.
Dieses Dokument gilt für Hohlvenenfilter, die dafür vorgesehen sind, durch Auffangen von Blutgerinnseln in der unteren Hohlvene (IVC, en: inferior vena cava) symptomatische Lungenembolien zu verhindern. Obwohl dieser Teil von ISO 25539 auf an anderen Positionen des Venensystems implantierte Filter (z. B. Vena cava superior, V.v. iliacae) anwendbar sein kann, behandelt er nicht speziell die Anwendung von Filtern an anderen Implantationspositionen.
Dieses Dokument gilt auch für permanente Filter mit ihren zugehörigen Einführsystemen, für rückholbare optionale Filter mit ihren zugehörigen Rückholsystemen und für konvertierbare Filter mit ihren zugehörigen Konversionssystemen. Obwohl dieser Teil von ISO 25539 hinsichtlich der Bewertung der Neuplatzierung der Filter nach chronischer Implantation anwendbar sein kann, behandelt er nicht speziell die Neuplatzierung von Filtern.
Dieses Dokument gilt nicht für temporäre Filter (z. B. „gebundene“ Filter), die nach einer festgelegten Zeitspanne wieder entfernt werden müssen, für Aspekte, die mit lebensfähigem Gewebe und lebensunfähigen biologischen Stoffen in Zusammenhang stehen, und für vor dem Hohlvenenfilterverfahren angewendete Verfahren und Geräte/Implantate (z. B. Venenpunktionskanülen).
Obwohl absorbierbare Filter und Filter mit absorbierbaren Beschichtungen innerhalb des Anwendungsbereiches dieses Dokuments liegen, ist dieses Dokument in Bezug auf die absorbierbaren Eigenschaften dieser Implantate nicht umfassend.
ANMERKUNG 2   Absorbierbare Implantate fallen in den Anwendungsbereich von ISO/TR 17137.
Obwohl beschichtete Filter und beschichtete Filtersysteme innerhalb des Anwendungsbereiches dieses Dokuments liegen, ist dieses Dokument hinsichtlich Beschichtungen nicht umfassend.
ANMERKUNG 3   Vaskuläre Medizinprodukt-Arzneimittel-Kombinationsprodukte fallen in den Anwendungsbereich von ISO 12417 1, und einige Beschichtungseigenschaften liegen im Anwendungsbereich von ISO 25539 4.

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 3 : Filtres caves (ISO/DIS 25539-3:2023)

Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 3. del: Filtri "vena cava" (ISO/DIS 25539-3:2023)

General Information

Status
Not Published
Publication Date
13-Oct-2024
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285 - Non-active surgical implants
Current Stage
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Start Date
09-Feb-2024
Completion Date
09-Feb-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
oSIST prEN ISO 25539-3:2023 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023)

Relations

Revises
EN ISO 25539-3:2011 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
Effective Date
19-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 25539-3:2023
01-september-2023
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 3. del: Filtri "vena
cava" (ISO/DIS 25539-3:2023)
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS
25539-3:2023)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 3: Hohlvenenfilter
(ISO/DIS 25539-3:2023)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 3 : Filtres caves
(ISO/DIS 25539-3:2023)
Ta slovenski standard je istoveten z: prEN ISO 25539-3
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 25539-3:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 25539-3:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 25539-3:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 25539-3
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-06-29 2023-09-21
Cardiovascular implants — Endovascular devices —
Part 3:
Vena cava filters
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 3: Filtres caves
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 25539-3:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 25539-3:2023
ISO/DIS 25539-3:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 25539-3
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:

Cardiovascular implants — Endovascular devices —
Part 3:
Vena cava filters
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 3: Filtres caves
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 25539-3:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 25539-3:2023
ISO/DIS 25539-3:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references .
...

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