AS ISO 25539.1-2003

1 - AS ISO 25539.1-2003 CARDIOVASCULAR IMPLANTS-ENDOVASCULAR DEVICES - ENDOVASCULAR PROSTHESES
4 - PREFACE
6 - CONTENTS
7 - INTRODUCTION
9 - 1 Scope
9 - 2 Normative references
10 - 3 Terms and definitions
10 - 3.1 attachment system
10 - 3.2 delivery system
10 - 3.3 determine
10 - 3.4 endoleak
10 - 3.5 endovascular prosthesis endovascular graft endovascular implant
11 - 3.6 endovascular system
11 - 3.7 evaluate
11 - 3.8 graft material
11 - 3.9 reportable clinical events
11 - 4 Intended performance
11 - 5 Design attributes
11 - 5.1 General
12 - 5.2 Delivery system
12 - 5.3 Implant
12 - 6 Materials
13 - 7 Design evaluation
13 - 7.1 General
13 - 7.2 Delivery (and/or endovascular) system
13 - 7.2.1 Ability to access
15 - 7.2.2 Ability to deploy
17 - 7.2.3 Ability to withdraw
18 - 7.2.4 Biocompatibility
18 - 7.2.5 Haemostasis
19 - 7.3 Implant
19 - 7.3.1 Ability to accurately deploy
20 - 7.3.2 Fixation effectiveness
21 - 7.3.3 Implant integrity
23 - 7.3.4 Permeability
23 - 7.3.5 Modularity
24 - 7.3.6 Sizing
25 - 7.3.7 Patency
26 - 7.3.8 Magnetic resonance imaging (MRI) compatibility
27 - 7.4 Preclinical in vivo evaluation
27 - 7.4.1 Purpose
27 - 7.4.2 Specific aims
27 - 7.4.3 Protocol
27 - 7.4.4 Data acquisition
29 - 7.4.5 Test report and additional information
30 - 7.5 Clinical evaluation
30 - 7.5.1 Purpose
30 - 7.5.2 Specific aims
30 - 7.5.3 Protocol
31 - 7.5.4 Data acquisition
32 - 7.5.5 Final report
33 - 8 Manufacturing
33 - 9 Sterilization
33 - 9.1 Products supplied sterile
34 - 9.2 Products supplied non-sterile
34 - 9.3 Sterilization residuals
34 - 10 Packaging
34 - 10.1 Protection from damage in storage and transport
34 - 10.1.1 General
34 - 10.1.2 Unit container
34 - 10.1.3 Outer container
34 - 10.1.4 Shipping container
34 - 10.1.5 Maintenance of sterility in transit
35 - 10.2 Marking
35 - 10.2.1 Container label
35 - 10.2.2 Record label
35 - 10.3 Information supplied by the manufacturer
35 - 10.3.1 General
36 - 10.3.2 Information and instructions for use
37 - Annex A - Attributes of endovascular devices - Technical and clinical considerations
44 - Annex B - Bench and analytical tests
47 - Annex C - Definitions of reportable clinical events
50 - Bibliography

Specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to AS ISO 14630, which specifies general requirements for the performance of non-active surgical implants. It is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.

1.1 This part of ISO 25539 specifies requirements for endovascular prostheses, based upon currentmedical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.1.2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.1.3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.1.4 This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.1.5 This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the endovascular system (defined in 3.6), such as balloon angioplasty devices.

First published as AS ISO 25539.1-2003.