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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 13-137
Standard
IEEE  Std 11073-10101b-2023
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
Scope/Abstract
The scope of this standard is to define a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications. This amendment extends IEEE Std 11073-10101-2019 to include additional terms primarily related to infusion pumps, ventilators, dialysis and other key medical devices as well as event and alert identifiers for devices and systems used in acute care.
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.
This standard provides updated and new nomenclature elements which support semantic data exchange between medical devices and other networked entities, and therefore supports improved safety, effectiveness and secure interoperability.
Transition Period
FDA recognition of IEEE Std 11073-10101-2019 [Rec# 13-114] will be superseded by recognition of IEEE Std 11073-10101b-2023 [Rec# 13-137]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-114] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 13-114] will not be accepted.
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.
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
 Anil Kochhar
  CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-2215
  anil.kochhar@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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