AS ISO 15539-2003 (R2014)

Table of Contents

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

Abstract

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 AS ISO 14630, 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.

RECONFIRMATION NOTICE
Technical Committee HE-012 has reviewed the content of this publication and in
accordance with Standards Australia procedures for reconfirmation, it has been determined
that the publication is still valid and does not require change.
Certain documents referenced in the publication may have been amended since the original
date of publication. Users are advised to ensure that they are using the latest versions of
such documents as appropriate, unless advised otherwise in this Reconfirmation Notice.
Approved for reconfirmation in accordance with Standards Australia procedures for
reconfirmation on 29 April 2014.
The following are represented on Technical Committee HE-012:
Australian College of Operating Room Nurses
Australian Dental Association
Australian Society for Biomaterials
Medical Technology Association of Australia
Neurosurgical Society of Australasia
Royal Australasian College of Surgeons
Royal Perth Hospital
Therapeutic Goods Administration

Scope

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 guidelines
to appropriate tests. Annex D gives medical definitions for reportable clinical events.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Reconfirmed 30/05/2014. This standard has been reconfirmed in Australia in 2014 and remains current in New Zealand. Reconfirmation Notice 30/05/2014
Pages
ISBN
Committee	HE-012
Supersedes	DR 03121 CP