AS ISO 25539.

1—2003
ISO 25539-1:2003
AS ISO 25539.1

Australian Standard™
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

Cardiovascular implants—Endovascular
devices

Part 1: Endovascular prostheses

 This Australian Standard was prepared by Committee HE-012, Surgical Implants. It
was approved on behalf of the Council of Standards Australia on 21 May 2003 and
published on 30 June 2003.

The following are represented on Committee HE-012:

Australian Chamber of Commerce and Industry
Australian College of Operating Room Nurses
Australian Dental Association
Australian Industry Group
Australian Orthopaedic Association
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Australian Society for Biomaterials

Commonwealth Department of Health and Ageing
Department of Defence (Australia)
Medical Industry Association of Australia Inc
Neurological Society of Australasia
Royal Australasian College of Surgeons
Royal Perth Hospital
University of New South Wales
University of Sydney

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Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW
2001.

This Standard was issued in draft form for comment as DR 03181.

 AS ISO 25539.1—2003

Australian Standard™
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

Cardiovascular implants—Endovascular
devices

Part 1: Endovascular prostheses

First published as AS ISO 25539.1—2003.

COPYRIGHT
© Standards Australia International
All rights are reserved. No part of this work may be reproduced or copied in any form or by any
means, electronic or mechanical, including photocopying, without the written permission of the
publisher.
Published by Standards Australia International Ltd
GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 5341 8
 ii

PREFACE
This Standard was prepared by the Australian members of the Joint Standards
Australia/Standards New Zealand Committee HE-012, Surgical Implants. After consultation
with stakeholders in both countries, Standards Australia and Standards New Zealand
decided to develop this Standard as an Australian, rather than an Australian/New Zealand
Standard.
This Standard is identical with and has been reproduced from ISO 25539-1:2003,
Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses.
The objective of this Standard is to specify 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
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

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.
The terms ‘normative’ and ‘informative’ are used to define the application of the annex to
which they apply. A normative annex is an integral part of a standard, whereas an
informative annex is only for information and guidance.
As this Standard is reproduced from an international Standard, the following applies:
(a) Its number does not appear on each page of text and its identity is shown only on the
cover and title page.
(b) In the source text ‘this International Standard’ should read ‘this Australian Standard’.
(c) A full point substitutes for a comma when referring to a decimal marker.
References to International Standards should be replaced by references to Australian or
Australian/New Zealand Standards as follows:
Reference to International Standard Australian Standard
ISO AS ISO
7198 Cardiovascular implants— 7198 Cardiovascular implants—
Tubular vascular prostheses Tubular vascular prostheses
10993 Biological evaluation of medical 10993 Biological evaluation of medical
devices devices
10993-1 Part 1: Evaluation and testing 10993.1 Part 1: Evaluation and testing
10993-3 Part 3: Tests for genotoxicity, 10993.3 Part 3: Tests for genotoxicity,
carcinogenicity and reproductive carcinogenicity and reproductive
toxicity toxicity
10993-4 Part 4: Selection of tests for 10993.4 Part 4: Selection of tests for
interactions with blood interactions with blood
10993-5 Part 5: Tests for in vitro 10993.5 Part 5: Tests for in vitro
cytotoxicity cytotoxicity
10993-6 Part 6: Tests for local effects after 10993.6 Part 6: Tests for local effects after
implantation implantation
10993-7 Part 7: Ethylene oxide 10993.7 Part 7: Ethylene oxide
sterilization residuals sterilization residuals
10993-8 Part 8: Selection and qualification 10993.8 Part 8: Selection and qualification
of reference materials for of reference materials for
 iii
Reference to International Standard
ISO
biological tests
10993-9 Part 9: Framework for
identification and quantification
of potential degradation products
10993-10 Part 10: Tests for irritation and
delayed-type hypersensitivity
10993-11 Part 11: Tests for systematic
toxicity
10993-12 Part 12: Sample preparation and
reference materials
10993-13 Part 13: Identification and
quantification of degradation
products from polymeric medical
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
devices
10993-14 Part 14: Identification and
quantification of degradation
products from ceramics
10993-15 Part 15: Identification and
quantification of degradation
products from metals and alloys
10993-16 Part 16: Toxicokinetic study
design for degradation products
and leachables
11134 Sterilization of health care
products—Requirements for
validation and routine control—
Industrial moist heat sterilization
11135 Medical devices—Validation and
routine control of ethylene oxide
sterilization
11137 Sterilization of health care
products—Requirements for
validation and routine control —
Radiation sterilization
13485 Quality systems—Medical
devices—Particular requirements
for the application of ISO 9001
13488 Quality systems—Medical
devices—Particular requirements
for the application of ISO 9002
14155 Clinical investigation of medical
devices
14160 Sterilization of single-use medical 14160
devices incorporating materials of
animal origin—Validation and
routine control of sterilization by
liquid sterilants
14630 Non-active surgical implants—
General requirements
Australian Standard
AS ISO
biological tests
10993.9 Part 9: Framework for
identification and quantification
of potential degradation products
10993.10 Part 10: Tests for irritation and
delayed-type hypersensitivity
10993.11 Part 11: Tests for systematic
toxicity
10993.12 Part 12: Sample preparation and
reference materials
10993.13 Part 13: Identification and
quantification of degradation
products from polymeric medical
devices
10993.14 Part 14: Identification and
quantification of degradation
products from ceramics
10993.15 Part 15: Identification and
quantification of degradation
products from metals and alloys
10993.16 Part 16: Toxicokinetic study
design for degradation products
and leachables
11134 Sterilization of health care
products—Requirements for
validation and routine control—
Industrial moist heat sterilization
11135 Medical devices—Validation and
routine control of ethylene oxide
sterilization
11137 Sterilization of health care
products—Requirements for
validation and routine control—
Radiation sterilization
13485 Quality systems—Medical
devices—Particular requirements
for the application of ISO 9001
13488 Quality systems—Medical
devices—Particular requirements
for the application of ISO 9002
14155 Clinical investigation of medical
devices
Sterilization of single-use medical
devices incorporating materials of
animal origin—Validation and
routine control of sterilization by
liquid sterilants
14630 Non-active surgical implants—
General requirements
 iv

CONTENTS

Introduction ........................................................................................................................................................ v
1 Scope...................................................................................................................................................... 1
2 Normative references ........................................................................................................................... 1
3 Terms and definitions........................................................................................................................... 2
4 Intended performance .......................................................................................................................... 3
5 Design attributes................................................................................................................................... 3
5.1 General ................................................................................................................................................... 3
5.2 Delivery system..................................................................................................................................... 4
5.3 Implant.................................................................................................................................................... 4
6 Materials................................................................................................................................................. 4
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7 Design evaluation ................................................................................................................................. 5

7.1 General ................................................................................................................................................... 5
7.2 Delivery (and/or endovascular) system .............................................................................................. 5
7.3 Implant.................................................................................................................................................. 11
7.4 Preclinical in vivo evaluation ............................................................................................................. 19
7.5 Clinical evaluation............................................................................................................................... 22
8 Manufacturing ..................................................................................................................................... 25
9 Sterilization .......................................................................................................................................... 25
9.1 Products supplied sterile ................................................................................................................... 25
9.2 Products supplied non-sterile ........................................................................................................... 26
9.3 Sterilization residuals ......................................................................................................................... 26
10 Packaging ............................................................................................................................................ 26
10.1 Protection from damage in storage and transport .......................................................................... 26
10.2 Marking................................................................................................................................................. 27
10.3 Information supplied by the manufacturer....................................................................................... 27
Annex A (informative) Attributes of endovascular devices— Technical and clinical considerations..... 29
Annex B (informative) Bench and analytical tests ........................................................................................ 36
Annex C (informative) Definitions of reportable clinical events .................................................................. 39
Bibliography ..................................................................................................................................................... 42
 v

INTRODUCTION

This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular
prostheses and the methods of test that will enable their evaluation. It is the first part of a proposed three-part
International Standard. ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for
the requirements. The Technical Specification was developed by first identifying the design requirements for
endovascular implants and listing the potential implant and clinical failure modes. Tests were then identified to
address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that
assessment.

Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the
relatively recent development of some of these implants, acceptable standardized in vitro tests and clinical
results are not always available. As further scientific and clinical data become available, appropriate revision
of this part of ISO 25539 will be undertaken.
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

vi

NOTES
 1

AUSTRALIAN STANDARD

Cardiovascular implants—Endovascular devices

Part 1: Endovascular prostheses

1 Scope
1.1 This part of ISO 25539 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
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

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.

2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

ISO 7198:1998, Cardiovascular implants — Tubular vascular prostheses

ISO 11134:1994, Sterilization of health care products — Requirements for validation and routine control —
Industrial moist heat sterilization

ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization

ISO 11137:1995, Sterilization of health care products — Requirements for validation and routine control —
Radiation sterilization

ISO 10993 (all parts), Biological evaluation of medical devices

ISO 11607:1997, Packaging for terminally sterilized medical devices

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13488:1996, Quality systems — Medical devices — Particular requirements for the application of
ISO 9002

ISO 14155 (all parts), Clinical investigation of medical devices for human subjects

www.standards.com.au  Standards Australia

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AS ISO 25539.1-2003, Cardiovascular implants -

Endovascular devices Endovascular prostheses
This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

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