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AS ISO 25539.1-2003

AS ISO 25539.1-2003

Cardiovascular implants - Endovascular devices Endovascular prostheses

Standards Australia

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Table of Contents

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

Abstract

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.

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 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.

General Product Information

Document Type Standard
Status Current
Publisher Standards Australia
ProductNote Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Committee HE-012
Supersedes
  • DR 03181 CP

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