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AS EN 45502.1-2002 (R2014)

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Active implantable medical devices – General requirements for safety, marking and information to be provided by the manufacturer
standard by Standards Australia,

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Description

Specifies requirements for active implantable medical devices for safety, marking and information to be provided by manufacturer.RECONFIRMATION NOTICETechnical Committee HE-012 has reviewed the content of this publication and inaccordance with Standards Australia procedures for reconfirmation, it has been determinedthat the publication is still valid and does not require change.Certain documents referenced in the publication may have been amended since the originaldate of publication. Users are advised to ensure that they are using the latest versions ofsuch documents as appropriate, unless advised otherwise in this Reconfirmation Notice.Approved for reconfirmation in accordance with Standards Australia procedures forreconfirmation on 29 April 2014.The following are represented on Technical Committee HE-012:Australian College of Operating Room NursesAustralian Dental AssociationAustralian Society for BiomaterialsMedical Technology Association of AustraliaNeurosurgical Society of AustralasiaRoyal Australasian College of SurgeonsRoyal Perth HospitalTherapeutic Goods Administration

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