1、BSI Standards Publication PD ISO/TS 22077-2:2015 Health informatics Medical waveform format Part 2: ElectrocardiographyPD ISO/TS 22077-2:2015 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TS 22077-2:2015. The UK participation in its preparation was entr
2、usted to Technical Committee IST/35, Health informatics. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The
3、British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 86356 1 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee
4、on 31 August 2015. Amendments issued since publication Date Text affectedPD ISO/TS 22077-2:2015 ISO 2015 Health informatics Medical waveform format Part 2: Electrocardiography Informatique de sant Forme donde mdicale Partie 2: Electrocardiographie TECHNICAL SPECIFICATION ISO/TS 22077-2 Reference num
5、ber ISO/TS 22077-2:2015(E) First edition 2015-08-01PD ISO/TS 22077-2:2015ISO/TS 22077-2:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized ot
6、herwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright offi
7、ce Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgPD ISO/TS 22077-2:2015ISO/TS 22077-2:2015(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Symbols and abbreviated
8、 terms . 2 5 Encoding format 2 5.1 Primary description 2 5.1.1 Sampling attributes . 3 5.1.2 Frame attributes . 3 5.1.3 Waveform . 4 5.1.4 Channel 6 5.2 Data alignment 7 5.3 Abstract waveform. 7 5.4 Lead calculation . 8 5.5 Filter information . 9 5.5.1 Description of filter-processed data . 9 5.5.2
9、Description of filter use information 9 5.6 Unique identifier . 9 6 Measurement information 10 6.1 Measurement date/time 10 6.2 Measurement time (classification point) 10 6.3 Measurement value 11 6.4 Measurement information classification .11 6.4.1 Observation event 11 6.4.2 Waveform ancillary infor
10、mation .11 6.4.3 Recording/display condition 11 6.5 Power supply frequency 12 6.6 Electrode condition 12 6.7 Calibration waveform .12 6.8 Artefact contamination .12 6.9 Automatic interpretation code, etc. 13 6.9.1 MFER interpretation code and heart beat code encoding rules 13 6.10 Patient informatio
11、n 14 6.10.1 Patient name .14 6.10.2 Patient ID .14 6.10.3 Age and date of birth .14 6.10.4 Gender 14 6.11 Comment .15 Annex A (informative) MFER Conformance statement .16 Annex B (informative) Waveform alignment 17 Annex C (informative) Encoding of waveform recognition point and measurement values .
12、26 Annex D (informative) Reference table of coding scheme 33 Annex E (informative) W a v eform v erification rule betw een E C G pr o vider and user .37 Bibliography .38 ISO 2015 All rights reserved iii Contents PagePD ISO/TS 22077-2:2015ISO/TS 22077-2:2015(E) Foreword ISO (the International Organiz
13、ation for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established
14、 has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. T
15、he procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the
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18、n explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for th
19、is document is ISO/TC 215, Health informatics. ISO/TS 22077 consists of the following parts, under the general title Health informatics Medical waveform format: Part 1: Encoding rules Part 2: Electrocardiography Part 3: Long term electrocardiographyiv ISO 2015 All rights reservedPD ISO/TS 22077-2:20
20、15ISO/TS 22077-2:2015(E) Introduction The standard 12-lead electrocardiogram (ECG) is one of the most widely used medical waveforms in clinical sites. In particular, the increased usage of electronic medical records provides the environment in which these ECGs can be accurately utilized; however, it
21、 is essential that to address the therapeutic requirements, ECG use is not constrained to specific machine types and manufacturers. Furthermore, there is great interest in the various kinds of patient information contained in ECGs that are extensively studied and shared between health care providers
22、. This Technical Specification defines the detailed rules for electrocardiogram waveform format that is encoded according to the medical waveform format encoding rules (MFER). In addition to electrocardiogram waveform format encoding, there are rules for other waveforms such as long-term ECG (Holter
23、 ECG), stress ECG, etc. that are contained in other MFER technical specifications. Please refer to those specifications for additional information. About MFER Medical waveforms such as electrocardiogram, electroencephalogram, and blood pressure waveforms are widely utilized in clinical areas such as
24、 physiological examinations, electronic medical records, medical investigations, research, education, etc. Medical waveforms are used in various combinations and document types according to the intended diagnostic purpose. For example, ECG waveforms are utilized extensively in the clinical arena, wi
25、th resting 12-lead ECG being used the most. A cardiologist makes diagnoses using 10 s to 15 s ECG waveform measurements; however, longer periods are sometimes required to recognize patient heart conditions such as arrhythmia. Also, there are many other methods using ECG such as Holter ECG, physiolog
26、ic monitoring ECG, stress ECG, intracardiac ECG, VCG, EEG with ECG, blood pressure with ECG, PSG, etc. MFER can describe not only ECG for physiological examinations conducted in ICU and operating room acute care contexts, but also EEG, respiration waveform, and pulse. Simple and easy MFER is a speci
27、alized representation for medical waveforms that removes unnecessary coded elements (“tags”) for waveform description. For example, a standard 12-lead ECG can be described simply only using a common sampling condition and the lead condition, making waveform synchronization and correct lead calculati
28、on much easier. Using with other appropriate standards It is recommended that MFER only describes medical waveforms. Other information can be described using appropriate standards such as HL7, DICOM, IEEE, etc. For example, clinical reports that include patient demographics, order information, medic
29、ation, etc. are supported in other standards such as HL7 Clinical Document Architecture (CDA); by including references to MFER information in these documents, implementation for message exchange, networking, database management that includes waveform information becomes simple and easy. Separation b
30、etween supplier and consumer of medical waveforms The MFER specification concentrates on data format instead of paper-based recording. For example, recorded ECG is processed by filter, data alignment, and other parameters, so that the ECG waveform can be easily displayed using an application viewer.
31、 However, it is not as useful for other purposes such as data processing for research investigations. A design goal of MFER is that a waveform is described in raw format with as complete as possible recording detail. When the waveform is used, appropriate processing of the data are supported like fi
32、ltering, view alignment and so on. In this way, the medical waveform described in MFER can be used for multiple purposes. Product capabilities are not limited Standards often support only a minimum set of requirements, so the expansion of product features can be greatly limited. MFER can describe me
33、dical waveform information without constraining the potential features of a product. Also, medical waveform display must be very flexible, and thus MFER ISO 2015 All rights reserved vPD ISO/TS 22077-2:2015ISO/TS 22077-2:2015(E) has mechanisms supporting not only a machine-readable coded system for a
34、bstract data, but also human-readable representation. The MFER specification can support both present and future product implementations. MFER supports the translation of stored waveform data that was encoded using other standards, enabling harmonization and interoperability. This capability support
35、s not only existing waveform format standards, but can be extended to support future formats as well.vi ISO 2015 All rights reservedPD ISO/TS 22077-2:2015TECHNICAL SPECIFICATION ISO/TS 22077-2:2015(E) Health informatics Medical waveform format Part 2: Electrocardiography 1 Scope This Technical Speci
36、fication defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiogram waveforms measured in physiological laboratories, hospital wards, clinics, and primary care medical checkups. It covers electrocardiograms such as 12-lead, 15- lead, 18-lead, Cabr
37、era lead, Nehb lead, Frank lead, XYZ lead, and exercise tests that are measured by inspection equipment such as electrocardiographs and patient monitors that are compatible with MFER. Medical waveforms that are not in the scope of this Technical Specification include Holter ECG, exercise stress ECG,
38、 and real-time ECG waveform encoding used for physiological monitors. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated referenc
39、es, the latest edition of the referenced document (including any amendments) applies. ISO 22077-1, Health informatics Medical waveform format Part 1: Encoding rules 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 3.1 dominant beat typical hear
40、t beat used for measurement and analysis in standard 12-lead ECG Note 1 to entry: In general, it is the primary heart beat excepting extrasystole or drifts of baseline. 3.2 average beat typical heart beat used for measurement and analysis in standard 12-lead ECG Note 1 to entry: This is averaged for
41、 waveforms excluding abnormal beats for each lead. 3.3 median beat typical heart beat used for measurement and analysis in standard 12-lead ECG Note 1 to entry: This is a waveform with the median value of waveforms excluding the abnormal beats for each lead. 3.4 tag identifier code for a semantic co
42、ncept ISO 2015 All rights reserved 1PD ISO/TS 22077-2:2015ISO/TS 22077-2:2015(E) 4 Symbols and abbreviated terms CEN Comit Europen de Normalization/European Committee for Standardization DBMS Data Base Management system DICOM Digital Imaging and Communications in Medicine ECG Electrocardiogram EEG E
43、lectroencephalogram EHR Electronic Health Record GPS Global Positioning System HL7 Health Level Seven IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers JIS Japanese Industrial Standard LSB Least significant bit MFER Medical waveform Format Encoding R
44、ules MSB Most significant bit OID Reference to the ISO standard SAS Sleep Apnea Syndrome SCP-ECG Standard Communications Protocol for Computerized Electrocardiography (ISO IS 11073- 91064) SpO2 Saturation of Peripheral Oxygen UID Reference to the ISO standard UUID Reference to the ISO standard VCG V
45、ectorcardiogram XML Extensible Markup Language 5 Encoding format 5.1 Primary description MFER provides encoding of Long-term ECG waveforms but since MFER is used mutatis mutandis for encoding of ECG waveforms such as ambulatory ECG, patient monitor system, etc., In addition, together with encoding o
46、f ECG waveforms, encoding of information of recognition for waveform, measurement information, interpretation information, etc. is provided, but these are all optional functions and are dependent on each implementation concept. For instance, interpretation code or measurement value might be describe
47、d by other standard such as HL7, XML, DBMS, etc. with waveforms decoding MFER. However, in all instances, when implementing a device, apply the requirements as listed in ISO 22077-1.2 ISO 2015 All rights reservedPD ISO/TS 22077-2:2015ISO/TS 22077-2:2015(E) 5.1.1 Sampling attributes Sampling attribut
48、es including sampling rate and resolution are given in Tables 1 to 4. 5.1.1.1 MWF_IVL (0Bh): Sampling rate This tag indicates the frequency or sampling interval for the medical waveform is sampled (Table 1). Table 1 Sampling rate MWF_IVL Data length Default Encoding range/remarks D upl i c at e d d
49、e f i n i- tions 11 0Bh Unit 1 1 000 Hz Override Exponent (10th power) 1 10 -128+127 Mantissa 4 e.g. unsigned 16-bit integer The unit may be frequency in hertz, time in seconds, or distance in meters (Table 2). Table 2 Sampling rate unit Unit Value Remarks Frequency Hz 0 Including power Time interval s 1 5.1.1.2 MWF_SEN (0Ch): Sampling resolution This tag indicates the resolution, minimum bits, the medical waveform sampled (generally, digitized) (Table 3). Table 3 Sampling resolution MWF_SEN Data length Default E
