scope:

This standard extends the base ISO/IEEE 11073-10101:2004¹ to provide support for ECG annotation terminology. Major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. It also defines additional "global" and "per-lead" numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201:2004 [B19]²) or independently with other standards.

Purpose

This standard provides a unified and comprehensive terminology for ECG annotation semantics, making it suitable for medical device data exchange that requires inclusion of ECG annotations. This standard consolidates numerous other standard and nonstandard terminologies that are in current use, resulting in the harmonization of how ECG annotation information is identified, enabling interoperability, and providing information exchange at the application level.Currently, many terminologies and protocols, both standard and vendor specific, are used to manage and exchange ECG annotation information. As a result, protocol converters and translators are required to integrate systems and applications, typically with some degree of semantic loss and noninteroperability. This standard provides a single terminology that is capable of supporting applications that require ECG annotations, including evaluation of patient condition (e.g., reviewing ECG data at the point-of-care or remotely) as well as clinical research (e.g., electronically submitting clinical drug trial evidence supporting the efficacy of a new medication). In addition to incorporating ECG annotations into an ISO/IEEE 11073- based information stream acquired at the bedside, the underlying nomenclature can also be used in other persistent and communication standards [e.g., Health Level Seven International (HL7) V2 and V3, and Digital Imaging and Communications in Medicine (DICOM)] for use by various applications, including clinical information systems, electronic patient records, and clinical research.

¹ Information on references can be found in Clause 2.

² The numbers in brackets correspond to those of the bibliography in Annex E.