BS ISO 25539-1 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
31-10-2009
English
01-01-2003
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Delivery system
5.3 Implant
6 Materials
7 Design evaluation
7.1 General
7.2 Delivery (and/or endovascular) system
7.3 Implant
7.4 Preclinical in vivo evaluation
7.5 Clinical evaluation
8 Manufacturing
9 Sterilization
9.1 Products supplied sterile
9.2 Products supplied non-sterile
9.3 Sterilization residuals
10 Packaging
10.1 Protection from damage in storage and transport
10.2 Marking
10.3 Information supplied by the manufacturer
Annex A (informative) Attributes of endovascular
devices - Technical and
clinical considerations
Annex B (informative) Bench and analytical tests
Annex C (informative) Definitions of reportable clinical events
Bibliography
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