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ANSI/AAMI/ISO 5840-3:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
Hardcopy , PDF
09-04-2024
English
04-12-2012
Glossary of equivalent standards
Committee representation
Background
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) - Rationale for the provisions
of this part of ISO 5840
Annex B (informative) - Examples of transcatheter
heart valve substitutes, components and
delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions
for use and training
Annex E (normative) - Sterilization
Annex F (informative) - Valve description
Annex G (informative) - Transcatheter heart valve
substitute hazards, associated failure modes
and evaluation methods
Annex H (informative) - In vitro test guidelines for
paediatric devices
Annex I (informative) - Statistical procedures when using
performance criteria
Annex J (informative) - Examples and definitions of some
physical and material properties of transcatheter
heart valve substitutes and their components
Annex K (informative) - Examples of standards applicable
to testing of materials and components of
transcatheter heart valve substitutes
Annex L (informative) - Raw and post-conditioning mechanical
properties for support structure materials
Annex M (informative) - Corrosion assessment
Annex N (informative) - Guidelines for verification of
hydrodynamic performance
Annex O (informative) - Durability testing
Annex P (informative) - Fatigue assessment
Annex Q (informative) - Preclinical in vivo evaluation
Annex R (normative) - Adverse event classification during
clinical investigation
Annex S (informative) - Echocardiographic protocol
Bibliography
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