Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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032
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Date of Entry 08/06/2013
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FR Recognition Number
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13-44
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Standard | |
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
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Identical AdoptionANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
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Scope/AbstractIEC/TR 80001-2-3:2012(E), which is a technical report, supports the Healthcare Delivery Organizations (HDO) in the risk management of medical IT-networks that incorporate one or more wireless links. The report, as part of IEC 80001, considers the use of wirelessly networked medical devices on a medical IT-network and offers practical techniques to address the unique risk management requirements of operating wirelessly enabled medical devices in a safe, secure and effective manner. The targeted audience for this technical report is the HDO IT department, biomedical and clinical engineering departments, risk managers, and the people responsible for design and operation of the wireless IT network. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Any procode which describes a networkable medical device |
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Relevant FDA Guidance and/or Supportive Publications*
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, August 2013
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |