EN ISO 5840:2005

SLOVENSKI STANDARD
01-februar-2006
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SIST EN 12006-1:2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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.

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 regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42
Clauses/Subclauses Essential Requirements Qualifying remarks/Notes
of the Standard of Directive 93/42
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
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 14
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. 21
7.4.2 General. 21
7.4.3 Number of institutions. 21
7.4.4 Number of patients . 21
7.4.5 Duration of the study. 22
7.4.6 Clinical data requirements. 22
7.4.7 Clinical investigation report. 24
Annex A (informative) Rationale for the provisions of this International Standard . 26
Annex B (informative) Heart valve substitute hazards, associated failure modes and
evaluation methods . 29
Annex C (informative) Risk assessment guidelines . 3
...