AS ISO 15539:2003(R2014) PDF

Scope: 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

AS ISO 15539:2003(R2014) history