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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 047 Date of Entry 08/21/2017 
FR Recognition Number 13-67
Standard
ISO IEEE  11073-10418 First edition 2014-03-01
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
Scope/Abstract
The scope of this standard is to establish a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personalcomputers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of functionality of INR devices.In the context of personal health devices, INR monitoring refers to the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions.This standard provides the data modeling and its transport shim layer according to IEEE Std 11073-20601aTM-20101 and does not specify the measurement method.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.7750 Test, Time, Prothrombin Class 2 GJS
Relevant FDA Guidance and/or Supportive Publications*
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005

Guidance for Off-the-Shelf Software Use in Medical Devices, September 1999

General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002


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
 Rachel Goehe
  FDA/OC/CDER/OGD/ORO/DLR/
  240-402-6565
  rachel.goehe@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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