EN ISO 5840-2:2015
(Main)Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
ISO 5840-2:2015 outlines an approach for qualifying the design and manufacture of a surgical 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 surgical 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 surgical heart valve substitute.
ISO 5840-2:2015 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840‑3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.
ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
ISO 5840-2:2015 excludes homografts.
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO 5840-2:2015)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires implantées chirurgicalement (ISO 5840-2:2015)
ISO 5840-2:2015 s'applique aux prothèses valvulaires destinées à être implantées dans le c?ur humain et nécessitant en général une circulation extra-corporelle et une visualisation directe.
ISO 5840-2:2015 s'applique à la fois aux prothèses valvulaires chirurgicales récemment mises au point et aux prothèses valvulaires chirurgicales modifiées ainsi qu'aux accessoires, à l'emballage et à l'étiquetage exigés pour leur implantation et pour la détermination de la taille appropriée de la prothèse valvulaire chirurgicale à implanter.
ISO 5840-2:2015 présente une approche pour la qualification de la conception et de la fabrication d'une prothèse valvulaire chirurgicale 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 chirurgicales 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 chirurgicales à l'état fini.
ISO 5840-2:2015 définit les exigences de performances relatives aux prothèses valvulaires chirurgicales lorsqu'une preuve scientifique et/ou clinique adéquate existe pour les justifier.
Pour les nouvelles prothèses valvulaires chirurgicales (par exemple, les prothèses sans suture), les exigences de la présente Norme internationale et de l'ISO 5840‑3 peuvent être pertinentes. Elles doivent être considérées comme applicables à la conception spécifique du dispositif et s'appuyer sur les résultats de l'analyse des risques.
ISO 5840-2:2015 exclut les prothèses valvulaires destinées à être implantées dans les c?urs artificiels ou dans des dispositifs d'assistance cardiaque.
ISO 5840-2:2015 ne couvre pas les allogreffes.
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 2. del: Kirurško vsajeni (implantirani) nadomestki srčne zaklopke (ISO 5840-2:2015)
Ta del standarda ISO 5840 velja za nadomestke srčne zaklopke, namenjene vsaditvi v človeško srce, ki navadno potrebujejo kardiopulmonalni obvod z neposredno vizualizacijo.
Ta del standarda ISO 5840 velja tako za na novo razvite in modificirane kirurške nadomestke srčne zaklopke kot tudi za dodatne naprave, zahteve glede pakiranja in označevanja za vsaditev ter določanje ustrezne velikosti nadomestka srčne zaklopke za vsaditev.
Ta del standarda ISO 5840 določa pristop za potrjevanje oblike in izdelave kirurškega nadomestka srčne zaklopke v skladu z obvladovanjem tveganj. Izbor ustreznih preskusov in metod za potrjevanje se izpelje iz ocene tveganja. Preskusi lahko vključujejo preskuse za oceno fizikalnih, kemičnih, bioloških in mehanskih lastnosti kirurških nadomestkov srčne zaklopke ter drugih materialov in sestavin. Preskusi lahko vključujejo tudi preskuse za predklinično oceno in vivo ter klinično oceno končanega kirurškega nadomestka srčne zaklopke.
Ta del standarda ISO 5840 opredeljuje obratovalne pogoje kirurških nadomestkov srčne zaklopke,
če je to potrebno na podlagi znanstvenih in/ali kliničnih dokazov.
Zahteve iz tega mednarodnega standarda kot tudi iz standarda ISO 5840-3 so morda relevantne za nove kirurške nadomestke srčne zaklopke, npr. brezšivne, veljajo za določene oblike naprav in morajo temeljiti na rezultatih ocene analize tveganja.
Ta del standarda ISO 5840 izključuje nadomestke srčnih zaklopk, namenjene vsaditvi v umetno srce ali napravo za podporo delovanja srca. Ta del standarda ISO 5840 izključuje homografte.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2015
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SIST EN ISO 5840:2009
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Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart
valve substitutes (ISO 5840-2:2015)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter
Herzklappenersatz (ISO 5840-2:2015)
Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Prothèse valvulaires
implantées chirurgicalement (ISO 5840-2:2015)
Ta slovenski standard je istoveten z: EN ISO 5840-2:2015
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 5840-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5840:2009
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
2: Surgically implanted heart valve substitutes (ISO 5840-
2:2015)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 2: Prothèse valvulaires implantées Teil 2: Chirurgisch implantierter Herzklappenersatz
chirurgicalement (ISO 5840-2:2015) (ISO 5840-2:2015)
This European Standard was approved by CEN on 24 July 2015.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5840-2:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4
European foreword
This document (EN ISO 5840-2:2015) 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 2016, and conflicting national standards shall
be withdrawn at the latest by September 2018.
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 5840:2009.
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, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 5840-2:2015 has been approved by CEN as EN ISO 5840-2:2015 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
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 Union 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.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
regulations.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC on medical devices
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this European Standard of Directive 93/42/EEC
Clause 5, 6.1, 6.2.1, 6.2.2, 6.4 7.1
6.2, 6.2.3, 6.4, 7.2.2.2 7.2
6.2, 6.4 7.3
6.2, 6.4, 6.5, 7.2.2.2 7.5
6.2.2, 6.4, 6.5 7.6
6.2, 6.4, 6.5 8.1
6.5, 7.2.2.2 8.2
6.2.3 8.3
6.2.3 8.4
6.4 8.5
6.2.3 8.6
6.2.3 8.7
6.3, 6.2.3 9.1
6.2.1, 6.2.2, 6.4, 6.5 9.2
6.2.3, 6.3 13
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 5840-2
First edition
2015-09-15
Cardiovascular implants — Cardiac
valve prostheses —
Part 2:
Surgically implanted heart valve
substitutes
Implants cardiovasculaires — Prothèses valvulaires —
Partie 2: Prothèse valvulaires implantées chirurgicalement
Reference number
ISO 5840-2:2015(E)
©
ISO 2015
ISO 5840-2:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
ISO 5840-2:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations. 4
5 Fundamental requirements . 4
6 Device description . 5
6.1 Intended use . 5
6.2 Design inputs . 5
6.2.1 Operational specifications . 5
6.2.2 Performance specifications . 5
6.2.3 Packaging, labelling, and sterilization . 6
6.3 Design outputs . 6
6.3.1 General. 6
6.4 Design transfer (manufacturing qualification) . 6
6.5 Risk management . 6
7 Design verification testing and analysis/design validation . 6
7.1 General requirements . 6
7.2 In vitro assessment . 7
7.2.1 Test conditions, sample selection, and reporting requirements . 7
7.2.2 Material property assessment . 8
7.2.3 Hydrodynamic performance assessment . 8
7.2.4 Structural performance assessment .10
7.2.5 Device MRI safety .11
7.2.6 Additional implant design evaluation requirements .11
7.2.7 Design specific testing .12
7.2.8 Simulated use.12
7.2.9 Human factors/usability assessment .12
7.3 Preclinical in vivo evaluation .12
7.3.1 Overall requirements .12
7.3.2 Methods .13
7.3.3 Test report .14
7.4 Clinical investigation .15
7.4.1 General.15
7.4.2 Statistical considerations .
...
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