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AS EN 501032002EN 50103:1995

Australian Standard

Guidance on the application of EN 29001and EN 46001 and of EN 29002 andEN 46002 for the active (including activeimplantable) medical device industry

AS

EN501

03

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This Australian Standard was prepared by Committee HE-012, Surgical Implants. It

was approved on behalf of the Council of Standards Australia on 26 June 2002 and

published on 28 June 2002.

The following are represented on Committee HE-012:

Australian Chamber of Commerce and Industry

Australian College of Operating Room Nurses

Australian Dental Association

Australian Industry Group

Australian Orthopaedic Association

Commonwealth Department of Health and Ageing

Department of Defence (Australia)

Medical Industry Association of Australia Inc

Neurological Society of Australasia

Royal Australasian College of Surgeons

Royal Perth Hospital

The Australian Society for Biomaterials

The University of New South Wales

The University of Sydney

Keeping Standards up-to-date

Standards are living documents which reflect progress in science, technology and

systems. To maintain their currency, all Standards are periodically reviewed, and

new editions are published. Between editions, amendments may be issued.

Standards may also be withdrawn. It is important that readers assure themselves

they are using a current Standard, which should include any amendments whichmay have been published since the Standard was purchased.

Detailed information about Standards can be found by visiting the Standards

Australia web site at www.standards.com.au and looking up the relevant Standardin the on-line catalogue.

Alternatively, the printed Catalogue provides information current at 1 January eachyear, and the monthly magazine, The Australian Standard, has a full listing of

revisions and amendments published each month.

We also welcome suggestions for improvement in our Standards, and especially

encourage readers to notify us immediately of any apparent inaccuracies or

ambiguities. Contact us via email at mail@standards.com.au, or write to the Chief

Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW2001.

This Standard was issued in draft form for comment as DR 02158.

http://www.standards.com.au/http://www.standards.com.au/

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www.standards.com.au Standards Australia

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