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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 051 Date of Entry 01/14/2019 
FR Recognition Number 13-106
Standard
IEEE  Std 11073-10207-2017
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
Scope/Abstract
The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073 Domain Information Model (IEEE 11073-10201 DIM). Furthermore, it utilizes the IEEE 11073 Nomenclature (IEEE 11073-10101) and supports other coding systems to convey the semantics of any information elements. The definition of network transport mechanisms is outside the scope of this standard.
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.
Relevant FDA Guidance and/or Supportive Publications*
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Issued September 2017.

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
 Sajjad Syed
  FDA/OC/CDRH/OPEQ/ORP/
  301-796-6295
  sajjad.syed@fda.hhs.gov
 Konstantinos Makrodimitris
  FDA/CDRH/OSPTI/DAHRSSP
  301-796-6946
  konstantinos.makrodimitris@fda.hhs.gov
Standards Development Organization
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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