16/30310949 DC : 0
NA
Status of Standard is Unknown
BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
Hardcopy , PDF
English
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 International Standard
Annex B (informative) - Examples of heart valve
repair devices and delivery systems
Annex C (normative) - Packaging
Annex D (normative) - Product labels, instructions
for use, and training
Annex E (normative) - Sterilization
Annex F (informative) - Heart valve repair system
characteristics
Annex G (informative) - Heart valve repair system
hazards, associated failure modes and
evaluation methods
Annex H (informative) - In vitro test guidelines for
paediatric devices
Annex I (informative) - Examples and definitions of
some physical and material properties of heart
valve repair devices and their components
Annex J (informative) - Examples of Standards
applicable to testing of materials and
components of heart valve repair devices
Annex K (informative) - Considerations for device
material properties undergoing alterations
post implantation
Annex L (informative) - Corrosion assessment
Annex M (informative) - Guidelines for in vitro
evaluation of functional performance
of the repair
Annex N (informative) - Durability testing
Annex O (informative) - Fatigue assessment
Annex P (informative) - Preclinical in vivo evaluation
Annex Q (normative) - Adverse event classification
during clinical investigation
Annex R (informative) - Imaging protocol
Annex S (informative) - Clinical investigation endpoints
for valve repair devices: Suggestions for
endpoints and their timing
Annex T (informative) - Additional device design
evaluation requirements
Annex U (informative) - Guidelines for delivery
system design evaluation testing
Bibliography
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