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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 13-49
ISO IEEE  11073-20101 First edition 2004-12-15
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are to:

- Provide real-time plug-and-play interoperability for patient-connected medical devices

- Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care environments

"Real-time" means that data from multiple devices can be retrieved, time correlated, and displayed or processed in fractions of a second. "Plug-and-play" means that all the clinician has to do is make the connection - the systems automatically detect, configure, and communicate without any other human interaction.

"Efficient exchange of medical device data" means that information that is captured at the point-of-care (e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of applications without extensive software and equipment support, and without needless loss of information. The standards are especially targeted at acute and continuing care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, etc. They comprise a family of standards that can be layered together to provide connectivity optimized for the specific devices being interfaced.
Extent of Recognition
Complete standard
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 Contacts
 Konstantinos Makrodimitris
 Sajjad Syed
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)
*These are provided as examples and others may be applicable.