AS ISO 15539-2003

1 - AS ISO 15539-2003 CARDIOVASCULAR IMPLANTS-ENDOVASCULAR PROSTHESES
4 - PREFACE
6 - CONTENTS
7 - INTRODUCTION
9 - 1 Scope
9 - 2 Normative references
10 - 3 Terms and definitions
10 - 3.1 endovascular device
10 - 3.2 vascular stent
10 - 3.3 vena cava filter
11 - 3.4 endovascular prosthesis
11 - 4 Intended performance
11 - 5 Design attributes
11 - 6 Materials
11 - 7 Design evaluation
11 - 8 Manufacturing
11 - 9 Sterilization
11 - 9.1 Products supplied sterile
12 - 9.2 Products supplied non-sterile
12 - 9.3 Sterilization residuals
12 - 10 Packaging
12 - 10.1 Protection from damage in storage and transport
12 - 10.2 Maintenance of sterility in transit
12 - 11 Information supplied by the manufacturer
13 - Annex A - Attributes of endovascular devices - Technical and clinical considerations
21 - Annex B - Accessory devices for endovascular procedures - Technical and clinical considerations
25 - Annex C - Bench and analytical tests
27 - Annex D - Definitions of reportable clinical events
30 - Bibliography
30 - International Standards
30 - Fatigue analysis
30 - Fixation of the filter within the vena cava
30 - Filtration
31 - Vascular stents
31 - Endoleaks and vascular grafts
31 - European medical device sterilization standards

Specifies, based on current medical knowledge, the evaluation of the ability of an endovascular device to meet specified medical situations. Additional recommendations on packaging and sterilization are also provided. This draft Standard will supplement ASISO14630, which specifies general requirements for the performance of non-active surgical implants. It is applicable to endovascular devices, such as endovascular prostheses, vascular stents and filters.

1.1 This Technical Specification gives recommendations, based on current medical knowledge, for evaluating the ability of an endovascular device to meet specified medical situations. Additional recommendations on packaging and sterilization are also provided.This Technical Specification should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.1.2 This Technical Specification is applicable to endovascular devices, such as endovascular prostheses, vascular stents and filters used in the following locations:a) aorta;b) coronary arteries;c) supra-aortic trunks (e.g. carotid arteries, vertebral arteries);d) pulmonary artery;e) visceral arteries (e.g. renal, mesenteric);f) peripheral arteries;g) arterio-venous access shunts;h) veins;i) vena cava;j) transjugular intrahepatic porto-systemic shunts (TIPS or TIPSS).1.3 This Technical Specification 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. The requirements as stated in ISO 14630 apply for excluded products.1.4 This Technical Specification is not applicable to procedures and devices used prior to the introduction of the endovascular devices (defined in 3.1 through 3.4), such as balloon angioplasty devices.NOTE Annexes A and B give structured guidelines to the appropriate tests/studies and information on requirements to check against specific device-related problems during the design of medical devices and accessories. Annex C gives guidelinesto appropriate tests. Annex D gives medical definitions for reportable clinical events.

First published as AS ISO 15539-2003.