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 AdoptionANSI 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/AbstractThis 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
|
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
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |