標準號：AS EN 45502.1-2002 (R2014)
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：Specifies requirements for active implantable medical devices for safety, marking and information to be provided by manufacturer. 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