M00027153
New product
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
International Organization for Standardization
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Availability date: 11/05/2021
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
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
Specifies an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 150 |
Supersedes |
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