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ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012

MEDICAL ELECTRICAL EQUIPMENT - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

This standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness, and data and system security.

This is done in redline so that you can see changes made by the amendment.

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October 21, 2013
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