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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 043 Date of Entry 06/27/2016 
FR Recognition Number 13-84
Standard
ISO IEEE  11073-10103 First edition 2014-03-01
Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
Scope/Abstract
ISO/IEEE 11073-10103:2014 extends the base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.
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*
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, Document Issued on October 28, 2003.

Guidance for Industry: Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement), Document issued on: November 5, 1998.

Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005.

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Document Issued on: October 2, 2014.


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
  FDA/CDRH/OSPTI/DAHRSSP
  301-796-6946
  konstantinos.makrodimitris@fda.hhs.gov
 Kan Fang
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6865
  Kan.Fang@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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