DIN EN ISO 5840-2 E : 2016
Current
The latest, up-to-date edition.
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
Hardcopy , PDF
English
01-01-2016
National foreword
National Annex NA (informative) - Bibliography
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
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
Bibliography
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