BS EN ISO 5840-1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
02-08-2021
English
10-31-2015
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
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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