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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 032 Date of Entry 08/06/2013 
FR Recognition Number 13-44
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
Identical Adoption
ANSI AAMI IEC TIR 80001-2-3:2012
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
Scope/Abstract
IEC/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.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Any procode which describes a networkable medical device
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.
FDA Technical Contact
 Brian Fitzgerald
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2579
  Brian.Fitzgerald@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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