14/30270462 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
31-10-2015
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 (normative) - Packaging
Annex C (normative) - Product labels, instructions
for use, and training
Annex D (normative) - Sterilization
Annex E (informative) - In vitro test guidelines
for paediatric devices
Annex F (informative) - Statistical procedures
when using in vitro performance criteria
Annex G (informative) - Examples and definitions
of some physical and material properties of
heart valve systems
Annex H (informative) - Examples of standards
applicable to testing of materials and
components of heart valve systems
Annex I (informative) - Raw and post-conditioning
mechanical properties for support structure
materials
Annex J (informative) - Corrosion assessment
Annex K (informative) - Echocardiographic protocol
Bibliography
Annex ZA (informative) - Relationship
between this European Standard
and the Essential Requirements of
EU Directive 93/42/EEC on medical
devices
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