1、BSI Standards Publication PD ISO/TS 22077-3:2015 Health informatics Medical waveform format Part 3: Long term electrocardiographyPD ISO/TS 22077-3:2015 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TS 22077-3:2015. The UK participation in its preparatio
2、n was entrusted 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 applica
3、tion. The British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 86357 8 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
4、Committee on 31 August 2015. Amendments issued since publication Date Text affectedPD ISO/TS 22077-3:2015 ISO 2015 Health informatics Medical waveform format Part 3: Long term electrocardiography Informatique de sant Forme donde mdicale Partie 3: lectrocardiographie de longue dure TECHNICAL SPECIFIC
5、ATION ISO/TS 22077-3 Reference number ISO/TS 22077-3:2015(E) First edition 2015-08-01PD ISO/TS 22077-3:2015ISO/TS 22077-3:2015(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 publicatio
6、n may be reproduced or utilized otherwise 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
7、 the requester. ISO copyright office 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 22077-3:2015ISO/TS 22077-3:2015(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definit
8、ions . 1 4 Symbols and abbreviated terms . 2 5 Encoding format 3 5.1 Primary description 3 5.1.1 Sampling attributes . 3 5.1.2 Frame attributes . 4 5.1.3 Waveform class . 4 5.2 Data alignment 5 5.2.1 Data encoding . 5 5.2.2 Recorder encoding . 6 5.2.3 Scanner encoding 9 5.3 Lead name 12 5.4 Lead cal
9、culation 13 5.5 Filter information 14 5.5.1 Description of filter-processed data 14 5.5.2 Description of filter use information .15 5.6 Unique identifier 15 6 Measurement information 15 6.1 Measurement date/time 15 6.2 Patient information 15 6.2.1 Patient name .15 6.2.2 Patient ID .16 6.2.3 Age and
10、date of birth .16 6.2.4 Gender 16 6.2.5 Comment17 Annex A (informative) MFER Conformance statement .18 Annex B (informative) Waveform encoding .19 Annex C (informative) Example of waveform coding21 Annex D (informative) Reference table of coding scheme 25 Bibliography .29 ISO 2015 All rights reserve
11、d iii Contents PagePD ISO/TS 22077-3:2015ISO/TS 22077-3:2015(E) Foreword ISO (the International Organization 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 co
12、mmittees. Each member body interested in a subject for which a technical committee has been established 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 th
13、e International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The 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
14、the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
15、 ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this d
16、ocument is information given for the convenience of users and does not constitute an endorsement. For an 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 T
17、rade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this 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: Elect
18、rocardiography Part 3: Long term electrocardiographyiv ISO 2015 All rights reservedPD ISO/TS 22077-3:2015ISO/TS 22077-3:2015(E) Introduction The ambulatory ECG examination is widely utilized in the clinical field. This rule applies for long-term waveform description such as ambulatory ECG, monitorin
19、g waveforms, etc. Recently, EMR, or Electronic Medical Records, becomes commonly used and it strongly requires Ambulatory ECG examination for the therapeutic purpose. However, new digitalized data of Ambulatory ECG recorder cannot be used among different manufacturers scanner. This Technical Specifi
20、cation intends that MFER encoded data for ambulatory ECG is analysed by other scanner and these are also interoperable on EMRs. This Technical Specification defines the detailed rules for electrocardiogram waveform format that is encoded according to the medical waveform format encoding rules (MFER)
21、. In addition to electrocardiogram waveform format encoding, there are rules for other waveforms such as long-term ECG (Holter ECG), stress ECG, etc. that are contained in other MFER Technical Specifications. Please refer to those specifications for additional information. About MFER Medical wavefor
22、ms such as electrocardiogram, electroencephalogram, and blood pressure waveforms are widely utilized in clinical areas such as physiological examinations, electronic medical records, medical investigations, research, education, etc. Medical waveforms are used in various combinations and document typ
23、es according to the intended diagnostic purpose. For example, ECG waveforms are utilized extensively in the clinical arena, with 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 rec
24、ognize patient heart conditions such as arrhythmia. Also, there are many other methods using ECG such as Holter ECG, physiologic 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
25、 in ICU and operating room acute care contexts, but also EEG, respiration waveform, and pulse. Simple and easy MFER is a specialized representation for medical waveforms that removes unnecessary coded elements (“tags”) for waveform description. For example, a standard 12-lead ECG can be described si
26、mply only using a common sampling condition and the lead condition, making waveform synchronization and correct lead calculation much easier. Using with other appropriate standards It is recommended that MFER only describes medical waveforms. Other information can be described using appropriate stan
27、dards such as HL7, DICOM, IEEE, etc. For example, clinical reports that include patient demographics, order information, medication, etc. are supported in other standards such as HL7 Clinical Document Architecture (CDA); by including references to MFER information in these documents, implementation
28、for message exchange, networking, database management that includes waveform information becomes simple and easy. Separation between supplier and consumer of medical waveforms The MFER specification concentrates on data format instead of paper-based recording. For example, recorded ECG is processed
29、by filter, data alignment, and other parameters, so that the ECG waveform can be easily displayed using an application viewer. 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
30、 as complete as possible recording detail. When the waveform is used, appropriate processing of the data are supported like filtering, 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 ofte
31、n support only a minimum set of requirements, so the expansion of product features can be greatly limited. MFER can describe medical 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
32、reserved vPD ISO/TS 22077-3:2015ISO/TS 22077-3:2015(E) has mechanisms supporting not only a machine-readable coded system for abstract data, but also human-readable representation. The MFER specification can support both present and future product implementations. MFER supports the translation of st
33、ored waveform data that was encoded using other standards, enabling harmonization and interoperability. This capability supports not only existing waveform format standards, but can be extended to support future formats as well.vi ISO 2015 All rights reservedPD ISO/TS 22077-3:2015TECHNICAL SPECIFICA
34、TION ISO/TS 22077-3:2015(E) Health informatics Medical waveform format Part 3: Long term electrocardiography 1 Scope This Technical Specification defines the application of medical waveform format encoding rules (MFER) to describe long-term electrocardiogram waveforms measured in physiological labor
35、atories and health care clinics. It covers electrocardiograms such as bipolar 2, 3-lead, 12-lead that are measured by medical equipment such as Holter electrocardiograph and patient physiological monitors that are compatible with the medical waveform format Encoding rules (MFER) Technical Specificat
36、ion (ISO 22077-1). 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 references, the latest edition of the referenced document (
37、including any amendments) applies. ISO 22077-1, Medical waveform format Part 1: Encoding rules 3 T erms a nd definiti ons 3.1 recorder recording equipment worn or carried by the patient including associated electrodes and cables for recording or recording and analysing heart action potentials Note 1
38、 to entry: Some recorders can record not only ECG but also non-invasive blood pressure measured automatically, SpO2, and respiratory waveform. 3.2 scanner equipment that retrieves ECG waveforms from the recorder and analyses and edits ECG waveforms provided by the recorder to determine the presence
39、of abnormal heart rhythms such as arrhythmia 3.3 patient event information or event for analysing the ECG. EXAMPLE For example, they may have chest pain, dizziness, or palpitatins, etc. Pushing a “patient event” switch located on the recorder allows for recording ECG waveforms with the time of occur
40、rence. 3.4 heart beat ECG cycle, comprising the P,QRS and the ST-T wave 3.5 dominant beat typical heart beat used for measurement and analysis Note 1 to entry: In general, it is decided for heart beat excepting extrasystole or drifts of baseline. ISO 2015 All rights reserved 1PD ISO/TS 22077-3:2015I
41、SO/TS 22077-3:2015(E) 3.6 average beat typical heart beat used for measurement and analysis Note 1 to entry: This is averaged for waveforms excluding abnormal beats for each lead. 3.7 abstract waveform one heartbeat of P-QRS-T, extracted by each lead for analyzing and editing 3.8 low battery battery
42、 voltage is low and exchange of battery is required 3.9 leads offelectrodes are disconnected 3.10 out of range poor condition on the radio field 3.11 pacing pulse pulsed waveform from artificial pacemaker 4 Symbols and abbreviated terms CEN Comit Europen de Normalization/European Committee for Stand
43、ardization DBMS Data Base Management system DICOM Digital Imaging and Communications in Medicine ECG Electrocardiogram EEG Electroencephalogram EHR Electronic Health Record GPS Global Positioning System HL7 Health Level Seven IEC International Electrotechnical Commission IEEE Institute of Electrical
44、 and Electronic Engineers JIS Japanese Industrial Standard LSB Least significant bit MFER Medical waveform Format Encoding Rules MSB Most significant bit OID Reference to the ISO standard SAS Sleep Apnea Syndrome2 ISO 2015 All rights reservedPD ISO/TS 22077-3:2015ISO/TS 22077-3:2015(E) SCP-ECG Stand
45、ard 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 Vectorcardiogram XML Extensible Markup Language 5 Encoding format 5.1 Primary description MFER provides
46、 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 of ECG waveforms, encoding of information of recognition for waveform, measurement information, interpr
47、etation 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 described by other standard such as HL7, XML, DBMS, etc. with waveforms decoding MFER. However, in all instanc
48、es, when implementing a device, apply the requirements as listed in ISO 22077-1. 5.1.1 Sampling attributes Sampling attributes 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
49、 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 e f i n i- tions 11 0Bh Sampling rate 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 of
