EN ISO 5840:2009
(Main)Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.
It is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
ISO 5840:2005 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
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)
L'ISO 5840:2005 s'applique à tous les dispositifs destinés à être implantés comme prothèses valvulaires dans le cœur humain.
Elle s'applique à la fois aux prothèses valvulaires récemment mises au point et aux prothèses valvulaires modifiées, ainsi qu'aux dispositifs auxiliaires, à l'emballage et à l'étiquetage exigés pour leur implantation et pour la détermination de la taille appropriée de la prothèse valvulaire à implanter.
L'ISO 5840:2005 souligne une approche destinée à qualifier la conception et la fabrication d'une prothèse valvulaire à travers la gestion des risques. La sélection des méthodes et des essais de qualification appropriés se fait à partir de l'appréciation du risque. Les essais peuvent inclure les essais destinés à évaluer les propriétés physiques, chimiques, biologiques et mécaniques des prothèses valvulaires ainsi que de leurs matériaux et composants. Ces essais peuvent également englober les essais destinés à l'évaluation préclinique in vivo et à l'évaluation clinique des prothèses valvulaires à l'état fini.
L'ISO 5840:2005 impose des spécifications de conception et des spécifications de performance minimale, pour les prothèses valvulaires, lorsqu'il existe des preuves scientifiques et/ou cliniques adéquates les justifiant.
Elle ne s'applique pas aux prothèses valvulaires destinées à être implantées dans des cœurs artificiels ou dans des dispositifs d'assistance cardiaque.
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko (ISO 5840:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 5840:2006
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMH3URWH]H]DVUþQR]DNORSNR ,62
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
Herz- und Gefäßimplantate - Herzklappenprothesen (ISO 5840:2005)
Implants cardiovasculaires - Prothèses valvulaires (ISO 5840:2005)
Ta slovenski standard je istoveten z: EN ISO 5840:2009
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 5840
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 5840:2005
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 19 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 5840:2009: 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 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 5840:2009 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 5840:2005.
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 EC Directive.
For relationship with EC 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 5840:2005 has been approved by CEN as a EN ISO 5840:2009 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-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
5 1, 2, 3, 6
6.1 1, 3
6.2.1 and 6.2.2 3, 4 Procedure for quality system
(design input) aiming at
supporting general ERs 3 and 4.
6.2.3 with annex P 3, 5, 8.1, 8.3
6.2.3 with annex Q 13.1, 13.3, 13.4, 13.5, 13.6 The part of ER 13.3 a) relating to
authorised representative is not
addressed in this European
Standard.
ER 13.3.f) is only partly
addressed in this European
Standard: safety issue
concerning single use.
The part of ER 13.6.h) relating to
single use is not addressed in
this European Standard.
ER 13.6.o) is not addressed in
this European Standard.
ER 13.6.q) is not addressed in
this European Standard.
6.2.3 with annex S 8.1, 8.3, 8.4
6.3 and 6.4 Elements of procedure for
Quality system aiming at
supporting all safety and
performance ERs
6.5 Elements of procedure for risk
management
7.1, 7.2.1 Elements of procedure for
quality system aiming at
supporting all safety and
performance ERs
7.2.2 1, 7.1, 8.2, 9.2, 12.7.1
7.2.3 3, 4
7.2.4 3, 4, 9.2, 12.7.1
7.3 1, 6 Preclinical in vivo evaluation also
aims at reducing the risks for
human subjects undergoing
clinical investigations
7.4 with annex R 6.a
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 5840
Fourth edition
2005-03-01
Cardiovascular implants — Cardiac valve
prostheses
Implants cardiovasculaires — Prothèses valvulaires
Reference number
ISO 5840:2005(E)
©
ISO 2005
ISO 5840:2005(E)
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ISO 5840:2005(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Abbreviations. 10
5 Fundamental requirements. 11
6 Device description. 11
6.1 Intended use. 11
6.2 Design inputs. 11
6.2.1 Operational specifications. 11
6.2.2 Performance specifications. 12
6.2.3 Packaging, labelling, and sterilization . 13
6.3 Design outputs. 13
6.3.1 General. 13
6.3.2 Examples of components of some heart valve substitutes . 13
6.4 Design transfer (manufacturing qualification). 14
6.5 Risk management. 14
6.5.1 Hazard identification. 14
6.5.2 Failure mode identification. 14
6.5.3 Risk estimation. 15
6.5.4 Risk evaluation. 15
6.5.5 Risk control. 15
6.5.6 Risk review. 15
7 Verification testing and analysis/Design validation . 15
7.1 General requirements. 15
7.2 In vitro assessment. 16
7.2.1 Test conditions, sample selection and reporting requirements . 16
7.2.2 Material property assessment. 16
7.2.3 Hydrodynamic performance assessment. 17
7.2.4 Structural performance assessment. 18
7.3 Preclinical in vivo evaluation. 19
7.3.1 Overall requirements. 19
7.3.2 Methods. 20
7.3.3 Test report. 20
7.4 Clinical investigation. 21
7.4.1 Principle.
...
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