Requirements for the Validation of In-House In-Vitro Diagnostic Devices

This document defines the requirements for the Validation of In House In Vitro Diagnostic Devices.

Page last updated: 2004

    Commonwealth of Australia 2004

    ISBN 0 642 82439 8
    This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth available from the Department of Communications, Information Technology and the Arts. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Intellectual Property Branch, Department of Communications, Information Technology and the Arts, GPO Box 2154, Canberra ACT 2601 or posted at
    Publication Approval Number 3428 (JN 8417)

    Publications Production Unit
    Australian Government Department of Health and Ageing

    The National Pathology Accreditation Advisory Council (NPAAC) was established in 1979 to consider and make recommendations to the Australian, state and territory governments on matters related to the accreditation of pathology laboratories and the introduction and maintenance of uniform standards of practice in pathology laboratories throughout Australia. A function of NPAAC is to formulate standards and initiate and promote guidelines and education programs about pathology tests.

    Publications produced by NPAAC are issued as accreditation material to provide guidance to laboratories and accrediting agencies about minimum standards considered acceptable for good laboratory practice.

    Failure to meet these minimum standards may pose a risk to public health and patient safety.

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