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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 062 Date of Entry 05/29/2024 
FR Recognition Number 13-135
Standard
ISO IEEE  11073-10407 Second edition 2022-12
Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
Scope/Abstract
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses the optimized framework created in IEEE Std 11073-20601-2019 and describes a specific, interoperable communication approach for blood pressure monitors. These standards align with and draw on the existing clinically focused standards to provide support for communication of data from personal health devices. Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute 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 behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth blood pressure monitors.
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FDA recognition of ISO IEEE 11073-10407 First edition 2010-05-01 [Rec# 13-57] will be superseded by recognition of ISO IEEE 11073-10407 Second edition 2022-12 [Rec# 13-135].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*
1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
2. Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
5. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005.
7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
8. Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
9. General Principles of Software Validation - Guidance for Industry and FDA Staff, issued January 2002.
10. Non-invasive Blood Pressure (NIBP) Monitor Guidance. Issued by: Center for Devices and Radiological Health (FDA), March 1997.
11. CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy - Guidance for FDA Staff and Industry, issued February 2005.
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
 Maria Isabel Tejero Del Rio
  FDA/OC/CDRH/OPEQ/OHTIII/
  301-796-5322
  Isabel.Tejero@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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