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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 13-40
Standard
IEC  TR 80001-2-1 Edition 1.0 2012-07
Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
Identical Adoption
ANSI AAMI IEC TIR 80001-2-1 2012
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
Scope/Abstract
This technical report provides step-by-step information to aid responsible organizations in implementation of the risk management process required by IEC 80001-1. Specifically, it details the steps involved in executing subclause 4.4 of IEC 80001-1:2010 and provides guidance in the form of a study of risk management terms, risk management steps, an explanation of each step, step-by-step examples, templates, and lists of hazards and causes to consider.

The steps outlined within this technical report are considered to be universally applicable. Application of these steps can be scaled as described within this document.
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*
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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