AAMI ISO 25539-3 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
Hardcopy , PDF
21-05-2020
English
01-01-2011
Glossary of equivalent standards
Committee Representation
Background of ANSI/AAMI adoption of ISO 25539-3:2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Attributes of endovascular
devices - Vena cava filters - Technical and
clinical considerations
Annex B (informative) - Descriptions of potential device
effects of failure and failure modes and descriptions
of detrimental clinical effects
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Annex E (informative) - Examples of terms for clinical use of
vena cava filters
Bibliography
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