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Description / Abstract:
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.