as en 45502.1-2002 active implantable medical devices general requirements for safety marking and...
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7/31/2019 As en 45502.1-2002 Active Implantable Medical Devices General Requirements for Safety Marking and Information
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AS EN 45502.12002EN 45502-1:1997
Australian Standard
Active implantable medical devices
Part 1: General requirements for safety,marking and information to be providedby the manufacturer
AS
EN455
02.1
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This Australian Standard was prepared by Committee HE-012, Surgical Implants. Itwas 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
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Standards are living documents which reflect progress in science, technology andsystems. To maintain their currency, all Standards are periodically reviewed, andnew editions are published. Between editions, amendments may be issued.Standards may also be withdrawn. It is important that readers assure themselvesthey 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 StandardsAustralia web site at www.standards.com.au and looking up the relevant Standard
in 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 ofrevisions and amendments published each month.
We also welcome suggestions for improvement in our Standards, and especiallyencourage readers to notify us immediately of any apparent inaccuracies orambiguities. Contact us via email at [email protected], or write to the ChiefExecutive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW2001.
This Standard was issued in draft form for comment as DR 02173.
http://www.standards.com.au/http://www.standards.com.au/ -
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AS EN 45502.1-2002, Active implantable medicaldevices General requirements for safety, markingand information to be provided by themanufacturer
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