DOI: 10.1097/JCE.0000000000000165

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Issn Print: 0363-8855

Publication Date: 2016/07/01


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ISO/IEC 80001 (Risk Management of Medical Devices on a Network)

Arif Subhan

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Excerpt

ISO/IEC 80001 (Risk Management of Medical Devices on a Network) is a topic within the section “Information Technology—Telecommunications.” The section of “Information Technology (IT)—Telecommunications” comprises 8% of the 2016 Certified in Clinical Engineering examination.1
This standard was approved by the Association for the Advancement of Medical Instrumentation (AAMI) in 2010 as ANSI/AAMI/IEC 80001-1:2010 and is titled “Application of risk management for IT networks incorporating medical devices, part 1: roles, responsibilities and activities.
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