ISO INTERNATIONAL STANDARD 41064 First edition 2023-06 Health informatics Standard communication protocol Computer- assisted electrocardiography Informatigue de santéProtocole de communication standard Electrocardiographie assistée par ordinateur Reference number IS0 41064:2023(E) ISO IS02023 IS0 41064:2023(E) COPYRIGHTPROTECTED DOCUMENT @IS02023 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on or ISoO's member body in the country of the requester. ISO copyright office CP 40i : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Email:[email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2023- All rights reserved IS0 41064:2023(E) @ Contents Page Foreworo Introductior 刀 1 Scope. 2 Normative references ... 3 Terms and definitions.... 4 Symbols and abbreviated terms... 5 Definitionofthedatacontentsandformat. 5.1 General considerations . 5.2 Specifications for the data structure. 5.3 Pointer section - Section O.... 10 5.4 Header information - Patient data/ECG metadata - Section 1 12 5.5 Huffman tables - Section 2.. 5.6 ECG leads definition - Section 3... 5.7 Reserved forlegacy SCP-ECGversions-Section4.. 39 5.8 Encoded type O reference beat data - Section 5 .. 5.9 Short-term ECG Rhythm data -- Section 6... 5.10 Global ECG measurements -- Section 7... 5.11 Storage of full text interpretive statements - Section 8... ..60 5.12 Storage of manufacturer specific interpretive statements and data related to the overreading trail - Section 9 .... .61 5.13 Per-lead ECG measurements - Section 10 ... 5.14 Storage of the universal ECG interpretive statement codes - Section 11.. .70 5.15 Long-term ECG rhythm data - Section 12, .74 5.16 Stress tests, Drug trials and Protocol based ECG recordings Metadata - Section 13. 5.17 Selected EcG Sequences Repository - Section 14.... 5.18 Beat-by-Beat EcG measurements and annotations - Section 15.. 5.19 Selected EcG beats measurements and annotations - Section 16 ... 109 5.20 Pacemaker Spikes measurements and annotations - Section 17 .. ..118 5.21 Additional ECG annotations - Section 18... .132 Annex A (normative) Supplementary information and additional encoding specifications .... 139 Annex B (informative) Universal ECG interpretation statements codes. .147 Annex C (informative) Definition of compliance with the SCP ECG standard... 173 Annex D (Informative) Methodology ofthe recommended EcG signal compression technique.... ..182 Annex E (informative) Cross-references to other EcG standards ... .217 Annex F (informative) Implementation Recommendations 220 Annex G (informative) Glossary 222 Annex H (informative) Revision History.. 224 Bibliography 227 IS0 2023 - All rights reserved iii IS0 41064:2023(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 committees. Each member body interested in a subject for which a technicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee. 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 ofelectrotechnicalstandardization. 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 the different types of Iso document 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). Iso draws attention to the possibility that the implementation of this doc