EN ISO 5840-1:2015
(Main)Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.
ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1:2015 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 preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1:2015 defines operational conditions for heart valve substitutes.
ISO 5840-1:2015 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen (ISO 5840-1:2015)
Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales (ISO 5840-1:2015)
ISO 5840-1:2015 s'applique aux prothèses valvulaires destinées à une implantation chez l'homme et indique des exigences générales. Les exigences spécifiques figurent dans les parties qui succèdent à la présente partie de l'ISO 5840.
ISO 5840-1:2015 s'applique à la fois aux prothèses valvulaires récemment mises au point et à celles qui ont été 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 à implanter.
ISO 5840-1:2015 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. Les 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.
ISO 5840-1:2015 définit les conditions de fonctionnement des prothèses valvulaires.
ISO 5840-1:2015 exclut les allogreffes.
NOTE Une justification des dispositions de la présente partie de l'ISO 5840 est donnée dans l'Annexe A.
Vsadki (implantati) za srce in ožilje - Proteze za srčno zaklopko - 1. del: Splošne zahteve (ISO 5840-1:2015)
Ta del standarda ISO 5840 velja za nadomestke srčne zaklopke, namenjene vsaditvi v človeško telo, in
določa splošne zahteve. Nadaljnji deli skupine standardov ISO 5840 določajo posebne zahteve. Ta del standarda ISO 5840 velja tako za na novo razvite in modificirane 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 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 nadomestkov srčne zaklopke ter drugih materialov in sestavin.
Preskusi lahko vključujejo tudi preskuse za predklinično oceno in vivo ter klinično oceno končanega nadomestka srčne zaklopke.
Ta del standarda ISO 5840 opredeljuje obratovalne pogoje nadomestkov srčne zaklopke.
Ta del standarda ISO 5840 izključuje homografte.
OPOMBA: pojasnilo določb tega dela standarda ISO 5840 je podano v dodatku A.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2015
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMH3URWH]H]DVUþQR]DNORSNRGHO 6SORãQH
]DKWHYH ,62
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO
5840-1:2015)
Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen
(ISO 5840-1:2015)
Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales (ISO
5840-1:2015)
Ta slovenski standard je istoveten z: EN ISO 5840-1:2015
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 5840-1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Cardiovascular implants - Cardiac valve prostheses - Part
1: General requirements (ISO 5840-1:2015)
Implants cardiovasculaires - Prothèses valvulaires - Herz- und Gefäßimplantate - Herzklappenprothesen -
Partie 1: Exigences générales (ISO 5840-1:2015) Teil 1: Allgemeine Anforderungen (ISO 5840-1:2015)
This European Standard was approved by CEN on 10 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 5840-1:2015 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 5840-1:2015) 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 March 2016.
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 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 5840-1:2015 has been approved by CEN as EN ISO 5840-1:2015 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
5, 6, 7 7.1
5, 6.2.4, 6.4, 6.5 7.2
6.2.2, 6.2.3, 7.3 7.3
6.5 7.5
6.2.2, 6.5 7.6
5, 6.4, 6.5 8.1
6.2.4, 6.4 8.3
6.2.4 8.4
6.4 8.5
6.2.4 8.6
6.2.4 8.7
6.2.1, 6.3, 7 9.1
6.2.1, 6.3, 6.4, 6.5, 7 9.2, 1. indent
6.4, 6.5, 7 9.2, 2. indent
6.4, 6.5, 7 9.2, 3. indent
6.2.1, 6.3, 6.4, 6.5, 7 9.2, 4. indent
6.2.4 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 5840-1
First edition
2015-09-15
Cardiovascular implants — Cardiac
valve prostheses —
Part 1:
General requirements
Implants cardiovasculaires — Prothèses valvulaires —
Partie 1: Exigences générales
Reference number
ISO 5840-1:2015(E)
©
ISO 2015
ISO 5840-1:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
ISO 5840-1:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations.11
5 Fundamental requirements .12
6 Device description .12
6.1 Intended use .12
6.2 Design inputs .12
6.2.1 Operational specifications .12
6.2.2 Performance specifications .12
6.2.3 Implant procedure.12
6.2.4 Packaging, labelling, and sterilization .13
6.3 Design outputs .13
6.4 Design transfer (manufacturing verification/validation) .14
6.5 Risk management .14
7 Design verification testing and analysis/design validation .15
7.1 General requirements .15
7.2 In vitro assessment .15
7.3 Preclinical in vivo evaluation .15
7.4 Clinical investigations .15
Annex A (informative) Rationale for the provisions of this part of ISO 5480 .16
Annex B (normative) Packaging .19
Annex C (normative) Product labels, instructions for use, and training .20
Annex D (normative) Sterilization .23
Annex E (informative) In vitro test guidelines for paediatric devices .24
Annex F (informative) Statistical procedures when using in vitro performance criteria .28
Annex G (informative) Examples and definitions of some physical and material properties
of heart valve systems .29
Annex H (informative) Examples of standards applicable to testing of materials and
components of heart valve systems .40
Annex I (informative) Raw and post-conditioning mechanical properties for support
structure materials .46
Annex J (informative) Corrosion assessment .48
Annex K (informative) Echocardiographic protocol .51
Bibliography .54
ISO 5840-1:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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