EN ISO 5840:2005

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

2005-12-01  60.60 de-synchornized, ISO/CS failed to notify of publication date.
2000-07-10  This WI should be processed in // VA/ISO lead with the revision of ISO 5840.
2000-04-20  Pending because the WI not yet created at ISO (NT).

Herz- und Gefäßimplantate - Herzklappenprothesen (ISO 5840:2005)

1.1   Diese Internationale Norm ist auf alle Geräte anwendbar, die für die Implantation im menschlichen Herzen als Herzklappenprothese vorgesehen sind.
1.2   Diese Internationale Norm ist sowohl auf neu entwickelte als auch auf veränderte Herzklappenprothesen und ihre Zubehörteile anwendbar, sie gilt weiter für die Verpackung und die für die Implantation und die Festlegung der geeigneten Größe der zu implantierenden Herzklappenprothese erforderliche Kennzeichnung.
1.3   Diese Internationale Norm umreißt eine Herangehensweise zur Qualitätsverbesserung der Gestaltung und Herstellung einer Herzklappenprothese mittels der Risikobeurteilung. Die Wahl der geeigneten Prüfungen und Verfahren für die Qualitätsverbesserung muss sich aus der Risikobeurteilung ableiten. Zu diesen Prüfungen können solche zur Beurteilung der physikalischen, chemischen, biologischen und mechanischen Eigenschaften von Herzklappenprothesen und von deren Werkstoffen und Bauteilen gehören. Diese Prüfungen können auch die vorklinische In-vivo-Bewertung und die klinische Bewertung der fertigen Herzklappenprothese einschließen.
1.4   Diese Internationale Norm legt Spezifikationen für die Gestaltung und Mindestleistungskriterien für Herzklappenprothesen fest, wo für deren Begründung angemessene wissenschaftliche und/oder klinische Nachweise vorliegen.
1.5   Diese Internationale Norm schließt Herzklappenprothesen aus, die für die Implantation in künstlichen Herzen oder herzunterstützenden Geräten konstruiert sind.
ANMERKUNG   Eine Begründung für die Festlegungen dieser Internationalen Norm findet sich in Anhang A.

Implants cardiovasculaires - Prothèses valvulaires (ISO 5840:2005)

Vsadki (implantati) za srce in ožilje – Proteze za srčno zaklopko (ISO 5840:2005)

General Information

• Status: Withdrawn
• Publication Date: 13-Dec-2005
• Withdrawal Date: 12-May-2009
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 3 - Cardiac and vascular implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 13-May-2009
• Completion Date: 13-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 5840:2006 - Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

Relations

• Replaces: EN 12006-1:1999 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 5840:2009 - Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 5840:2006
01-februar-2006
1DGRPHãþD
SIST EN 12006-1:2000
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH±3URWH]H]DVUþQR]DNORSNR,62
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
Herz- und Gefäßimplantate - Herzklappenprothesen (ISO 5840:2005)
Implants cardiovasculaires - Protheses valvulaires (ISO 5840:2005)
Ta slovenski standard je istoveten z: EN ISO 5840:2005
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 5840:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 5840
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2005
ICS 11.040.40 Supersedes EN 12006-1:1999
English Version
Cardiovascular implants - Cardiac valve prostheses (ISO
5840:2005)
Implants cardiovasculaires - Prothèses valvulaires (ISO Herz- und Gefäßimplantate - Herzklappenprothesen (ISO
5840:2005) 5840:2005)
This European Standard was approved by CEN on 28 February 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5840:2005: E
worldwide for CEN national Members.

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EN ISO 5840:2005 (E)




Foreword



The text of ISO 5840:2005 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 5840:2005 by
Technical Committee CEN/TC 285 "Non-active surgical implants", the secretariat of which is held by NEN.

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 June 2006, and conflicting national standards shall be withdrawn at
the latest by June 2006.

This document supersedes EN 12006-1:1999.

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(s).

For relationship with EU Directive(s), 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, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.



Endorsement notice

The text of ISO 5840:2005 has been approved by CEN as EN ISO 5840:2005 without any modifications.


2

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EN ISO 5840:2005 (E)

ANNEX ZA
(informative)

Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42


By agreement between ISO and CEN, this CEN annex is included in the DIS and the FDIS but will not
appear in the published ISO standard.


This International Standard has been prepared under a mandate given to CEN by the European Commission
to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42.

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 normative
clauses of this standard given in Table ZA.1 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 regulation
...