I.S. EN 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
03-02-2021
English
01-01-2013
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
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