I.S. EN ISO 5840-2:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
Hardcopy , PDF
22-02-2021
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
7 Design verification testing and analysis/design
validation
Annex A (informative) - Heart valve substitute hazards,
associated failure modes, and evaluation methods
Annex B (informative) - In vitro procedures for testing
unstented or similar valves in compliant chambers
Annex C (informative) - Preclinical in vivo evaluation
Annex D (informative) - Description of the surgical heart
valve substitute
Annex E (informative) - Examples of components of some
surgical heart valve substitutes
Annex F (informative) - Guidelines for verification of
hydrodynamic performance
Annex G (informative) - Durability testing
Annex H (informative) - Examples of design specific testing
Annex I (informative) - Fatigue assessment
Annex J (normative) - Methods of evaluating clinical data
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
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