DIN EN ISO 5840-1 E : 2015
Current
The latest, up-to-date edition.
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
Hardcopy , PDF
English
01-01-2015
National foreword
National Annex NA (informative) - Bibliography
European foreword.
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 5480
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on medical devices
Bibliography
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