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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 13-83
Standard
AAMI TIR57:2016 Principles for medical device security - Risk management.
Scope/Abstract
Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Document Issued on: October 2, 2014.

Postmarket Management of Cybersecurity in Medical Devices- Draft Guidance for Industry and Food and Drug Administration Staff, Document issued on: January 22, 2016.

NIST Special Publication 800-82, Guide to Industrial Control Systems (ICS) Security, June 2011.

FDA Technical Contact
 Brian Fitzgerald
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-2579
  brian.fitzgerald@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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