BS ISO 41064:2023

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Health informatics. Standard communication protocol. Computer-assisted electrocardiography

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BSI	2023	246

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Categories: 35.240.80 - IT applications in health care technology, BSI

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PDF Pages	PDF Title
2	undefined
6	Foreword
8	Introduction
13	1 Scope 2 Normative references 3 Terms and definitions
15	4 Symbols and abbreviated terms
16	5 Definition of the data contents and format 5.1 General considerations
17	5.2 Specifications for the data structure
18	Figure 1 — SCP-ECG record overview
19	Figure 2 — Section layout overview Table 1 — SCP-ECG data structure
22	5.3 Pointer section – Section 0
24	Figure 3 — Section 0 – Pointer section – data part overview 5.4 Header information – Patient data / ECG metadata – Section 1 5.4.1 General 5.4.2 Introduction to the section data part 5.4.3 Basic methodology
25	5.4.4 Overview of the data part of the “Header information” section
26	Figure 4 — Overview of the “Header information” section data part 5.4.5 Specification of the header information content Table 2 — Specification of the defined parameters
40	5.5 Huffman tables – Section 2
41	Table 3 — Example byte structure (Huffman code)
42	Figure 5 — Overview of the data part of the Huffman tables section 5.6 ECG leads definition – Section 3
43	Table 4 — Lead Identification Codes
51	Figure 6 — Overview of the data part of the ECG leads definition section 5.7 Reserved for legacy SCP-ECG versions – Section 4
53	Figure 7 — Overview of the data part of section 4 5.8 Encoded type 0 reference beat data – Section 5
54	Table 5 — Example of difference data calculation for the first four samples
55	Table 6 — Example of encoded results using 2nd differences Table 7 — Example of encoded results using 1st differences
56	Figure 8 — Overview of the data part of the encoded type 0 reference beat section 5.9 Short-term ECG Rhythm data – Section 6
58	Figure 9 — Overview of the data part of the rhythm data section 5.10 Global ECG measurements – Section 7 5.10.1 General 5.10.2 Section ID Header
59	5.10.3 Global ECG measurement data and pacemaker spike measurement data 5.10.3.1 General 5.10.3.2 Global ECG measurement data header
60	5.10.3.3 Global ECG wave delineation and electrical axes measurement data
61	Figure 10 — Angle definition for the electrical axes in the frontal plane 5.10.3.4 Pacemaker spike measurement data (if any)
62	5.10.3.5 Pacemaker Spike Information 5.10.3.6 QRS type information
63	5.10.3.7 Additional Global measurements
64	Table 8 — Tagged Global ECG Measurements data fields
70	Figure 11 — Angle definitions in the X, Y, Z space 5.10.4 Manufacturer specific global measurement block 5.10.5 Overview of the data part of the global measurements section
71	Figure 12 — Overview of the data part of the global measurements section
72	5.11 Storage of full text interpretive statements – Section 8
73	Figure 13 — Overview of the data part of Section 8 5.12 Storage of manufacturer specific interpretive statements and data related to the overreading trail – Section 9 5.13 Per-lead ECG measurements – Section 10 5.13.1 General
74	5.13.2 Section ID Header 5.13.3 Data part content 5.13.4 Special codes utilization specification 5.13.5 Per-lead ECG measurements data header 5.13.6 Lead measurement block format
80	5.13.6.1 P and T morphology codes 5.13.6.2 Signal Quality codes
81	5.13.6.3 ST and ST-T shape/morphology codes 5.13.7 Overview of the data part of the per-lead measurements section Figure 14 — Overview of the data part of the per-lead ECG measurements section
82	5.14 Storage of the universal ECG interpretive statement codes – Section 11 5.14.1 General 5.14.2 Section ID header 5.14.3 Section data structure and format 5.14.4 Section data part content 5.14.4.1 Section data part Header
83	5.14.4.2 Statement data format
84	5.14.4.3 Statement body data content specification in function of the statement type
85	5.14.5 Overview of the data part of the universal ECG interpretation statement codes storage section
86	Figure 15 — Overview of the data part of Section 11 5.15 Long-term ECG rhythm data – Section 12 5.15.1 General 5.15.2 Section ID Header
87	5.15.3 Data part content and format 5.15.4 Data part Header 5.15.4.1 Header format
89	5.15.4.2 Additional specifications 5.15.5 Leads Definition block Table 9 — Long-term ECG lead quality score
90	5.15.6 ECG signals data block 5.15.7 Overview of the data part of the long-term ECG rhythm data section
91	Figure 16 — Overview of the data part of Section 12 5.16 Stress tests, Drug trials and Protocol based ECG recordings Metadata – Section 13 5.16.1 General
92	5.16.2 Section ID Header
93	5.16.3 Data part content and format 5.16.3.1 Data part Header
95	5.16.3.2 Leads Definition block 5.16.3.3 Events Metadata Blocks
101	5.16.4 Overview of the data part of the Stress tests, drug trials and protocol based ECG recordings metadata
102	Figure 17 — Overview of the data part of Section 13 5.17 Selected ECG Sequences Repository – Section 14 5.17.1 General 5.17.1.1 Section explanation 5.17.1.2 Usage constraint 5.17.1.3 Use cases
103	5.17.1.4 Associated metadata 5.17.2 Section ID header 5.17.3 Data part content and format 5.17.4 Data part Header 5.17.5 Leads Definition block
104	5.17.6 ECG sequences
106	5.17.7 Overview of the data part of the selected ECG sequences repository section Figure 18 — Overview of the data part of Section 14 5.18 Beat-by-Beat ECG measurements and annotations – Section 15 5.18.1 General
108	5.18.2 Section ID Header 5.18.3 Section data part 5.18.3.1 Data Header
109	5.18.3.2 Additional Beat Measurements and Annotations Definition block
112	5.18.3.3 Beat-by Beat Measurements Arrays
116	5.18.4 (Single) Beat Measurements data Block (MB) structure 5.18.4.1 Description of the data content of each beat Measurements and annotations data Block
118	5.18.4.2 Overview of the data content of a single beat Measurements and annotations Block (MB)
119	Figure 19 — Overview of the data content of each beat Measurements Block MB 5.18.5 Overview of the data part of the Beat-by-Beat ECG measurements and annotations section Figure 20 — Overview of the data part of Section 15 5.18.6 Example of encoded beat measurements and annotations
120	Table 10 — Tabular representation of the coded content of a typical (Beat x Measurements/Annotations) Array
121	5.19 Selected ECG beats measurements and annotations – Section 16 5.19.1 General
122	5.19.2 Section ID Header 5.19.3 Section data part 5.19.3.1 General
123	5.19.3.2 Data Header
125	5.19.3.3 Optional Beat Measurements and Annotations Definition block
126	5.19.3.4 Selected Beats Measurements Blocks
127	5.19.4 (Single) Beat Measurements data Block (MB) structure 5.19.4.1 Description of the data content of each beat Measurements and annotations data Block
129	5.19.4.2 Overview of the data content of a single beat Measurements and annotations Block (MB) Figure 21 — Overview of the data content of each beat Measurements Block MB 5.19.5 Overview of the data part of the Selected ECG beats measurements and annotations section
130	Figure 22 — Overview of the data part of Section 16 5.20 Pacemaker Spikes measurements and annotations – Section 17 5.20.1 General
132	5.20.2 Section ID Header 5.20.3 Section data part 5.20.3.1 General 5.20.3.2 Section Data Header
133	5.20.3.3 Additional Spikes Measurements and Annotations Definition block
135	5.20.3.4 Spike-by-Spike Measurements Arrays
139	5.20.4 (Single) Spike Measurements data Block (MB) structure 5.20.4.1 Description of the data content of each spike Measurements and annotations data Block
141	5.20.4.2 Overview of the data content of a single spike Measurements and annotations Block (MB) Figure 23 — Overview of the data content of a typical spike Measurements Block (MB) 5.20.5 Overview of the data part of the Pacemaker Spikes Measurements and Annotations section
142	Figure 24 — Overview of the data part of Section 17 5.20.6 Example of encoded spike measurements and annotations
143	Table 11 — Tabular representation of the coded content of a typical (Spike x Measurements/Annotations) Array
144	5.21 Additional ECG annotations – Section 18 5.21.1 General 5.21.2 Section ID header 5.21.3 Section Data part
145	5.21.3.1 Data Header
146	5.21.3.2 (Single) Annotation (ANN) data block structure
148	5.21.3.3 Overview of the data content of a single additional annotations data block (ANN) Figure 25 — Overview of the data content of a single Annotation data block ANN 5.21.4 (Single) annotation Entry data format description 5.21.4.1 Entry data format 5.21.4.2 Entry data field content specification in function of the Entry type
149	5.21.4.3 Overview of the data content of a single annotation Entry
150	Figure 26 — Overview of the data content of a single annotation Entry 5.21.5 Overview of the data part of section 18 “Additional Measurements and Annotations” Figure 27 — Overview of the data part of Section 18
151	Annex A (normative) Supplementary information and additional encoding specifications A.1 Supplementary information to Table 2, Clause 5.4.5 A.1.1 SCP-ECG specific drug class and drug sub class encoding Table A.1 — SCP-ECG Drug Class Codes (DCC) Table A.2 — SCP-ECG Specific Drug Codes (SDC)
154	A.1.2 Language support encoding in legacy SCP-ECG versions Table A.3 — Multilingual character sets encoding in legacy SCP-ECG files
155	A.1.3 Implanted cardiac devices functionalities encoding Table A.4 — NASPE/BPEG revised (2002) NBG pacemaker code
156	Table A.5 — NASPE/BPEG generic NBD defibrillator code A.2 Encoding of additional filtering methods used for ECG processing Table A.6 — Filter bit map (FBM) to be used for encoding additional ECG filtering methods
157	A.3 Encoding of the units of measure of the workload level WL Table A.7 — Typical ULL unit codes for the measure of the workload level WL A.4 Encoding of the physical units and/or type of measurements and annotations
158	Table A.8 — Typical units codes for ECG measurements and annotations
159	Annex B (informative) Universal ECG interpretation statements codes B.1 General B.2 Constraints B.3 Composition of the code and general syntax rules B.3.1 General principle
160	B.3.2 Basic composition of the code B.3.3 Modifiers
162	B.3.4 Separation delimiters
163	B.3.5 Conjunctive terms
164	B.4 Acronyms for ECG interpretive statements B.4.1 References used for the elaboration of this proposal
165	B.4.2 Acronyms B.4.2.1 Normal/Abnormal B.4.2.2 Ventricular Hypertrophy
166	B.4.2.3 Myocardial Infarction B.4.2.4 Intraventricular and intra-atrial conduction disturbances
167	B.4.2.5 Other QRS morphology or general descriptive statements
168	B.4.2.6 Rhythm Statements
174	B.4.2.7 Pacemaker types and pacemaker function
176	B.4.2.8 Descriptive axis statements B.4.2.9 ST-T descriptive statements
180	B.4.2.10 U wave descriptive statements B.4.2.11 Atrial statements
181	B.4.2.12 Statements related to paediatric ECG analysis B.4.2.13 Statements related to stress ECG analysis B.4.2.14 Statements related to serial ECG analysis B.4.2.15 Statements related to the ECG calibration B.4.2.16 Technical conditions and problems
182	B.4.3 Examples B.4.3.1 The statements “Probable old anterior infarction and atrial fibrillation” shall be coded as follows: AMI_OL_PR; AFIB. The statement AFIB has no direct relation to AMI, therefore the AND conjunction is not used. There are in fact 2 independent … B.4.3.2 The statement “Probable left ventricular hypertrophy with ST-T changes compatible with left ventricular strain” is coded as follows: LVH_PR_AND_STT_LV. The underscore signs before and after the AND indicates that the conjunction is made within… B.4.3.3 If the same statement had been made on 2 separate lines, and one wants to link them logically, i.e.: B.5 Overreading of measurement results B.5.1 Waveform and interval designations
183	B.5.2 Lead denominators
184	B.5.3 Units of measurement B.5.4 Examples Most of the time rather simple single or composite ECG interpretive statements, such as listed in B.4.3 will be generated, but more complex statements can also be created such as listed in the examples shown below. It should be noted that these abbrev…
185	Annex C (informative) Definition of compliance with the SCP ECG standard C.1 General C.2 Compliance specification C.2.1 Data Format Categories
186	C.2.2 Data Exchange Functions C.2.2.1 Export C.2.2.2 Import C.2.2.3 Transfer C.2.2.4 Communication Channel C.2.3 SCP-ECG Messaging/transport protocol
187	C.2.4 Specification for Statement of Compliance C.2.5 Hypothetical Examples: C.2.5.1 Cardiograph
188	C.2.5.2 Management System C.2.5.3 Defibrillator 12-lead ECG
189	C.3 Testing/validation of SCP-ECG data format compatibility C.3.1 Overview Figure C.1 — Import validation diagram C.3.2 Requirements
190	C.3.3 ECG Binary File Format (*.EC0, *.EC1)
191	Table C.1 — Example for the first 6 samples for 8 ECG leads C.4 Coding of SCP-ECG compliance C.5 Minimum requirements for SCP-ECG versions V1.x and V2.x ECG data compression C.5.1 General
192	C.5.2 Minimum requirements for ECG data encoding and compression C.5.2.1 If reference beat subtraction is used for data compression, all leads of an ECG record shall be recorded simultaneously. C.5.2.2 Digitization: SR ≥ 500 samples/s; LSB ≤ 5 µV C.5.2.3 Reference Beat: SR ≥ 500 samples/s; LSB ≤ 5 µV C.5.2.4 Residual Record: Truncation Error ≤ ± 15 µV C.5.2.5 Residual Record: Sampling Interval ≤ 8 ms C.5.2.6 Reconstruction Error: RMS ≤ 10 µV C.5.2.7 Absolute Error: ≤ 100 µV in a single sample outside P-QRS-T C.5.2.8 Absolute Error within QRS: ≤ 15 µV in a single sample C.6 CRC error detection algorithm Figure C.2 — CRC-CCITT error detection
194	Annex D (Informative) Methodology of the recommended ECG signal compression technique D.1 General D.2 Introduction D.3 Principles of “HIGH” SCP-ECG data compression D.3.1 Original ECG – “raw data”
195	Figure D.1 — Example of raw data, fiducials and QRS typing D.3.2 Reference Beat type 0 Figure D.2 — Example of a reference beat D.3.3 Residual Record after beat subtraction
196	Figure D.3 — Example of a residual record D.3.4 Sample decimation and 2nd difference encoding Figure D.4 — Example of residual data after sample decimation and 2nd difference encoding D.3.5 Huffman Encoding
197	D.3.6 Decompression of SCP-ECG data D.4 Equations for SCP-ECG data compression D.4.1 Definitions D.4.1.1 Raw data D.4.1.2 Sample number and time relationship
198	D.4.1.3 Examples of denomination and indexing of ECG data D.4.1.3.1 Raw data D.4.1.3.2 Reference Beat D.4.1.4 Pointers D.4.1.4.1 Raw data
199	D.4.1.4.2 Reference beat D.4.1.4.3 Residual record D.4.2 Truncation of all values to 5 µV resolution D.4.2.1 General D.4.2.2 Raw data
200	D.4.2.3 Reference Beat data D.4.3 Subtraction of the Reference Beat from the raw signal data D.4.3.1 General D.4.3.2 Truncated raw data Figure D.5 — Example of raw data, fiducials and QRS typing
201	Table D.1 — Locations and types of QRS complexes D.4.3.3 Computation of the Residual Data D.4.3.3.1 Align (“synchronize”) the fiducial point fcM of reference beat type 0 data with each of the fiducial points fc1, fc2, fc4, …, fc(k) for beat type 0 complexes of the raw data. See Figure D.6. Figure D.6 — Example of a reference beat and reference beat pointers
202	Table D.2 — Direct storage locations of pointers D.4.3.3.2 Subtract sample by sample the reference beat data from the raw data at the respective cycle location fc(k). D.4.3.3.3 For practical reasons it is most convenient to subtract constantly the “complete” reference beat data from PBM to TEM (this segment has the length LM). The pointers for the beginning and end of the subtraction of the reference beat data for … D.4.3.3.4 The data remaining after subtraction of the reference beat at all suitable complex locations fc(k) are called “Residual Record”. D.4.4 Low-pass Filtering D.4.4.1 Low-pass filtering of the residual record improves effectively the compression ratio. Since high frequency components are usually found only within the QRS, all data segments except those where QRS complexes were located, can be filtered and s…
203	D.4.4.2 Pointers to the protected data segment of cycle k are computed as follows: D.4.4.3 A simple non-recursive moving average filter has given sufficient results for low-pass filtering of the Residual Record. The filter length, L, is 9 samples.
205	D.4.5 Sample decimation Table D.3 — Example of filtering and decimation
206	D.4.6 Computation and Storage of the Difference Data D.4.6.1 General
207	D.4.6.2 Computation of First and Second Successive Differences D.4.6.3 Reconstitution of the data from the differences D.4.7 Huffman encoding within SCP-ECG D.4.7.1 General
208	D.4.7.2 Pure Huffman encoding D.4.7.3 Initial Encoding D.4.7.4 Huffman tables used in SCP-ECG D.4.7.4.1 General D.4.7.4.2 Structure of the Huffman tables
209	Table D.4 — Huffman table # 1 Table D.5 — Huffman table # 2 D.4.7.4.3 Huffman tables without Table Mode Switch
210	Table D.6 — Alignment of byte oriented data values and Huffman code bits D.4.7.4.4 Huffman Tables with Table Mode Switch
211	Table D.7 — Alignment of byte oriented data values and Huffman code bits
212	D.4.7.5 Definition and storage of the Huffman tables in Section 2 Table D.8 — Example of storage of two sample Huffman tables in Section 2
213	D.4.7.6 Definition of the Default SCP-ECG Huffman table Table D.9 — Default SCP-ECG Huffman table
214	D.4.7.7 Definition of other than 16-bit fixed length ECG data D.4.8 Decoding of Compressed ECG Data D.4.8.1 General D.4.8.2 Decoding with Huffman tables D.4.8.3 Reconstitution of the First and Second Differences D.4.8.3.1 General D.4.8.3.2 First differences
215	D.4.8.3.3 Second differences D.4.8.4 Reconstitution of decimated samples
216	Table D.10 — Example of decimation and reconstitution of 100 samples
217	D.4.8.5 Low-pass filtering of Reconstructed Residual Record D.4.8.6 Multiplication of raw data with AVM D.4.8.6.1 General D.4.8.6.2 Raw data D.4.8.6.3 Reference Beat data D.4.8.7 Addition of the Reference Beat to the Residual Record
218	D.4.8.8 Default SCP-ECG Decompression Parameters D.4.8.9 Default Method for Interpolation of decimated samples
219	D.4.8.10 Default Method for Three Sample Point Moving Average
220	D.5 Numerical examples for SCP-ECG data compression D.5.1 Example 1
221	Table D.11 — Data obtained during SCP-ECG high compression
222	D.5.2 Example 2 Table D.12 — SCP-ECG pure redundancy reduction
223	D.6 Test set of ECGs used for “high” compression and decompression errors assessment
224	Table D.13 — Test set for error verification of SCP-ECG high compression methods
225	Figure D.7 — ECG for the example data (lead V1 to V6)
226	D.7 Background information for ECG data compression and decompression in legacy SCP-ECG records D.7.1 General D.7.2 Scope and field of application D.7.3 Introduction D.7.4 Main results from investigations on ECG data compression in the SCP-ECG project
227	D.7.5 ECG compression methodology in brief
229	Annex E (informative) Cross-references to other ECG standards E.1 General E.2 Lead identification codes E.3 Universal Interpretation Statement codes
230	Table E.1 — Snapshot of the Interpretation statements codes and acronyms cross-reference list provided in the form of a set of Excel tables
232	Annex F (informative) Implementation Recommendations F.1 General F.2 Reasonable length of text fields Table F.1 — Reasonable length of SCP-ECG text fields
234	Annex G (informative) Glossary
236	Annex H (informative) Revision History
239	Bibliography

Additional information

Status	Definitive
Pages	246
Publication Date	2023-06-30
ISBN	978 0 539 22589 1
Standard Number	BS ISO 41064:2023
Title	Health informatics. Standard communication protocol. Computer-assisted electrocardiography
Identical National Standard Of	ISO 41064
Replaces	BS ISO 11073-91064:2009
Descriptors	Medical informatics, Public health, Communication procedures, Communication processes, Cardiovascular system, Computer-assisted management
Publisher	BSI
Committee	IST/35
ICS Codes	35.240.80 - IT applications in health care technology

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