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80001-1 Managing Medical IT-Networks

80001-1ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities aims to ensure both the delivery of safe, high-quality healthcare, and the security and privacy of patient data as medical devices and information management systems converge.

80001-1 specifies general requirements for the application of risk management of IT-networks incorporating medical devices that achieve essential properties such as safety, effectiveness, data & system security and interoperability. It defines responsibilities for parties such as medical device manufacturers, non-medical device manufacturers, the responsible organization, IT-network integrator, and potentially others, engaged in installing, using, reconfiguring, maintaining and decommissioning IT-networks incorporating medical devices. This Standard addresses risks related to patients, operators and/or third parties.

Implementing IEC 80001-1 will help you understand and address the requirements of the FDA's MDDS regulation. It is also integral to successfully deploying technology in support of the Office of the National Coordinator for Health Information Technology’s meaningful use requirements.  80001-1 aids in the successful deployment and management of networked medical technology to truly realize the anticipated clinical and organizational benefits.

Click here to view the Table of Contents, Introduction, and Scope of IEC 80001-1 (PDF)

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80001-1-PDF

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AAMI offers four Technical Information Reports to aid in understanding and implementing 80001-1:

Order the set of Getting Started with IEC 80001 and the 80001-1 standard and SAVE!

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Getting Started with IEC 80001 AND 80001-1 standard

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Getting Started with IEC 80001 AND 80001-1 standard (PDF)

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