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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
12-02-2021
30-09-2015
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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.