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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 13-57
Standard
ISO IEEE  11073-10407 First edition 2010-05-01
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
Scope/Abstract
ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors.

ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
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.
Transition Period
FDA recognition of ISO IEEE 11073-10407 First edition 2010-05-01 [Rec# 13-57] will be superseded by recognition of ISO IEEE 11073-10407 Second edition 2022-12 [Rec# 13-135]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-57] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 13-57] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1130 System, Measurement, Blood-Pressure, Non-Invasive Class 2 DXN
Relevant FDA Guidance and/or Supportive Publications*
Non-invasive Blood Pressure (NIBP) Monitor Guidance, March 10, 1997

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
 Linda Ricci
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  301-796-6325
  linda.ricci@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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