AAMI ISO 5840-1 : 2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
22-06-2018
English
01-01-2016
Glossary of equivalent standards
Committee representation
Background on AAMI adoption of ISO 5840-1:2015
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 5840
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
pediatric 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
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