Abstract
Updates to industry consensus standards for ECG equipment is a work-in-progress by the ISO/IEC Joint Work Group 22. This work will result in an overhaul of existing industry standards that apply to ECG electromedical equipment and will result in a new single international industry, namely 80601-2-86. The new standard will be entitled “80601, Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables, and leadwires”. This paper will provide a high-level overview of the work in progress and, in particular, will describe the impact it will have on requirements and testing methods for computerized ECG interpretation algorithms. The conclusion of this work is that manufacturers should continue working with clinical ECG experts to make clinically meaningful improvements to automated ECG interpretation, and the clinical validation of ECG analysis algorithms should be disclosed to guide appropriate clinical use. More cooperation is needed between industry, clinical ECG experts and regulatory agencies to develop new data sets that can be made available for use by industry standards for algorithm performance evaluation.
Highlights
Industry standards are published for particular types of electromedical equipment by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO)
More cooperation is needed between industry, clinical ECG experts and regulatory agencies to develop new data sets that can be made available for use by industry standards for algorithm performance evaluation
Work that is in progress by the Joint Workgroup 22 (JWG22) under the ISO/IEC 62D Electromedical Equipment Subcommittee will result in the publication of a new standard for ECG devices and systems with the designation of ISO/IEC 80601-2-86, which will be entitled “80601, Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables, and leadwires” [1]
Summary
Industry standards are published for particular types of electromedical equipment by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). Work that is in progress by the Joint Workgroup 22 (JWG22) under the ISO/IEC 62D Electromedical Equipment Subcommittee will result in the publication of a new standard for ECG devices and systems with the designation of ISO/IEC 80601-2-86, which will be entitled “80601, Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables, and leadwires” [1]. JWG22 is a joint workgroup formed between the maintenance team that oversees the ECG particular standards and liaisons from other standard workgroups This new standard is currently in draft form and constitutes a significant overhaul of current ECG equipment standards and, in effect, combines the three current ECG particular standards published by the IEC for diagnostic electrocardiographs [2], ECG patient monitors [3], and ambulatory ECG equipment [4]. The intention of this paper is narrowed in focus to give the reader a cursory level of understanding of the work in progress and a more detailed discussion about the impact it will have, on performance requirements for computerized diagnostic ECG analysis algorithms, which is commonly referred to by other terms, such as automated ECG interpretation or computerized ECG interpretation
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