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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.

NOTE: Conformance to this standard may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act or the recommendations in the (1) listed below (Relevant FDA Guidance). Manufacturers should consider the information contained within these resources in their assessment of cybersecurity for their device.
Public Law, CFR Citation(s) and Procode(s)*
Any procode which describes a networkable medical device
Relevant FDA Guidance and/or Supportive Publications*
1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued February 2026.

2. Postmarket Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued December 2016.

3. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued September 2017.

4. 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
 Priya Aswani
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-5101
  priya.aswani@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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