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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 043 Date of Entry 06/27/2016 
FR Recognition Number 13-82
Standard
ANSI AAMI ISO  TIR 80001-2-6:2014
Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
Scope/Abstract
ISO/TR 80001-2-6:2014 provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL 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.
Relevant FDA Guidance and/or Supportive Publications*
1. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued June 2025.

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

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
 CDRH Division of Medical Device Cybersecurity
  FDA/OC/CDRH/OST/ORR/
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  CyberMed@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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