Abstract

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

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Reconfirmed 30/05/2014. This standard has been reconfirmed in Australia in 2014 and remains current in New Zealand. Reconfirmation Notice 30/05/2014
Pages
ISBN
Committee	HE-012
Supersedes	DR 02173 CP