BS ISO 41064:2023 – TC
$280.87
Tracked Changes. Health informatics. Standard communication protocol. Computer-assisted electrocardiography
| Published By | Publication Date | Number of Pages |
| BSI | 2023 | 582 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 338 | undefined |
| 342 | Foreword |
| 344 | Introduction |
| 349 | 1 Scope 2 Normative references 3 Terms and definitions |
| 351 | 4 Symbols and abbreviated terms |
| 352 | 5 Definition of the data contents and format 5.1 General considerations |
| 353 | 5.2 Specifications for the data structure |
| 354 | Figure 1 — SCP-ECG record overview |
| 355 | Figure 2 — Section layout overview Table 1 — SCP-ECG data structure |
| 358 | 5.3 Pointer section – Section 0 |
| 360 | 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 |
| 361 | 5.4.4 Overview of the data part of the “Header information” section |
| 362 | 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 |
| 376 | 5.5 Huffman tables – Section 2 |
| 377 | Table 3 — Example byte structure (Huffman code) |
| 378 | Figure 5 — Overview of the data part of the Huffman tables section 5.6 ECG leads definition – Section 3 |
| 379 | Table 4 — Lead Identification Codes |
| 387 | Figure 6 — Overview of the data part of the ECG leads definition section 5.7 Reserved for legacy SCP-ECG versions – Section 4 |
| 389 | Figure 7 — Overview of the data part of section 4 5.8 Encoded type 0 reference beat data – Section 5 |
| 390 | Table 5 — Example of difference data calculation for the first four samples |
| 391 | Table 6 — Example of encoded results using 2nd differences Table 7 — Example of encoded results using 1st differences |
| 392 | Figure 8 — Overview of the data part of the encoded type 0 reference beat section 5.9 Short-term ECG Rhythm data – Section 6 |
| 394 | 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 |
| 395 | 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 |
| 396 | 5.10.3.3 Global ECG wave delineation and electrical axes measurement data |
| 397 | Figure 10 — Angle definition for the electrical axes in the frontal plane 5.10.3.4 Pacemaker spike measurement data (if any) |
| 398 | 5.10.3.5 Pacemaker Spike Information 5.10.3.6 QRS type information |
| 399 | 5.10.3.7 Additional Global measurements |
| 400 | Table 8 — Tagged Global ECG Measurements data fields |
| 406 | 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 |
| 407 | Figure 12 — Overview of the data part of the global measurements section |
| 408 | 5.11 Storage of full text interpretive statements – Section 8 |
| 409 | 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 |
| 410 | 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 |
| 416 | 5.13.6.1 P and T morphology codes 5.13.6.2 Signal Quality codes |
| 417 | 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 |
| 418 | 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 |
| 419 | 5.14.4.2 Statement data format |
| 420 | 5.14.4.3 Statement body data content specification in function of the statement type |
| 421 | 5.14.5 Overview of the data part of the universal ECG interpretation statement codes storage section |
| 422 | 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 |
| 423 | 5.15.3 Data part content and format 5.15.4 Data part Header 5.15.4.1 Header format |
| 425 | 5.15.4.2 Additional specifications 5.15.5 Leads Definition block Table 9 — Long-term ECG lead quality score |
| 426 | 5.15.6 ECG signals data block 5.15.7 Overview of the data part of the long-term ECG rhythm data section |
| 427 | 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 |
| 428 | 5.16.2 Section ID Header |
| 429 | 5.16.3 Data part content and format 5.16.3.1 Data part Header |
| 431 | 5.16.3.2 Leads Definition block 5.16.3.3 Events Metadata Blocks |
| 437 | 5.16.4 Overview of the data part of the Stress tests, drug trials and protocol based ECG recordings metadata |
| 438 | 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 |
| 439 | 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 |
| 440 | 5.17.6 ECG sequences |
| 442 | 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 |
| 444 | 5.18.2 Section ID Header 5.18.3 Section data part 5.18.3.1 Data Header |
| 445 | 5.18.3.2 Additional Beat Measurements and Annotations Definition block |
| 448 | 5.18.3.3 Beat-by Beat Measurements Arrays |
| 452 | 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 |
| 454 | 5.18.4.2 Overview of the data content of a single beat Measurements and annotations Block (MB) |
| 455 | 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 |
| 456 | Table 10 — Tabular representation of the coded content of a typical (Beat x Measurements/Annotations) Array |
| 457 | 5.19 Selected ECG beats measurements and annotations – Section 16 5.19.1 General |
| 458 | 5.19.2 Section ID Header 5.19.3 Section data part 5.19.3.1 General |
| 459 | 5.19.3.2 Data Header |
| 461 | 5.19.3.3 Optional Beat Measurements and Annotations Definition block |
| 462 | 5.19.3.4 Selected Beats Measurements Blocks |
| 463 | 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 |
| 465 | 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 |
| 466 | Figure 22 — Overview of the data part of Section 16 5.20 Pacemaker Spikes measurements and annotations – Section 17 5.20.1 General |
| 468 | 5.20.2 Section ID Header 5.20.3 Section data part 5.20.3.1 General 5.20.3.2 Section Data Header |
| 469 | 5.20.3.3 Additional Spikes Measurements and Annotations Definition block |
| 471 | 5.20.3.4 Spike-by-Spike Measurements Arrays |
| 475 | 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 |
| 477 | 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 |
| 478 | Figure 24 — Overview of the data part of Section 17 5.20.6 Example of encoded spike measurements and annotations |
| 479 | Table 11 — Tabular representation of the coded content of a typical (Spike x Measurements/Annotations) Array |
| 480 | 5.21 Additional ECG annotations – Section 18 5.21.1 General 5.21.2 Section ID header 5.21.3 Section Data part |
| 481 | 5.21.3.1 Data Header |
| 482 | 5.21.3.2 (Single) Annotation (ANN) data block structure |
| 484 | 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 |
| 485 | 5.21.4.3 Overview of the data content of a single annotation Entry |
| 486 | 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 |
| 487 | 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) |
| 490 | A.1.2 Language support encoding in legacy SCP-ECG versions Table A.3 — Multilingual character sets encoding in legacy SCP-ECG files |
| 491 | A.1.3 Implanted cardiac devices functionalities encoding Table A.4 — NASPE/BPEG revised (2002) NBG pacemaker code |
| 492 | 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 |
| 493 | 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 |
| 494 | Table A.8 — Typical units codes for ECG measurements and annotations |
| 495 | 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 |
| 496 | B.3.2 Basic composition of the code B.3.3 Modifiers |
| 498 | B.3.4 Separation delimiters |
| 499 | B.3.5 Conjunctive terms |
| 500 | B.4 Acronyms for ECG interpretive statements B.4.1 References used for the elaboration of this proposal |
| 501 | B.4.2 Acronyms B.4.2.1 Normal/Abnormal B.4.2.2 Ventricular Hypertrophy |
| 502 | B.4.2.3 Myocardial Infarction B.4.2.4 Intraventricular and intra-atrial conduction disturbances |
| 503 | B.4.2.5 Other QRS morphology or general descriptive statements |
| 504 | B.4.2.6 Rhythm Statements |
| 510 | B.4.2.7 Pacemaker types and pacemaker function |
| 512 | B.4.2.8 Descriptive axis statements B.4.2.9 ST-T descriptive statements |
| 516 | B.4.2.10 U wave descriptive statements B.4.2.11 Atrial statements |
| 517 | 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 |
| 518 | 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 |
| 519 | B.5.2 Lead denominators |
| 520 | 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… |
| 521 | Annex C (informative) Definition of compliance with the SCP ECG standard C.1 General C.2 Compliance specification C.2.1 Data Format Categories |
| 522 | 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 |
| 523 | C.2.4 Specification for Statement of Compliance C.2.5 Hypothetical Examples: C.2.5.1 Cardiograph |
| 524 | C.2.5.2 Management System C.2.5.3 Defibrillator 12-lead ECG |
| 525 | C.3 Testing/validation of SCP-ECG data format compatibility C.3.1 Overview Figure C.1 — Import validation diagram C.3.2 Requirements |
| 526 | C.3.3 ECG Binary File Format (***.EC0, ***.EC1) |
| 527 | 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 |
| 528 | 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 |
| 530 | 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” |
| 531 | 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 |
| 532 | 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 |
| 533 | 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 |
| 534 | 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 |
| 535 | 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 |
| 536 | 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 |
| 537 | 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 |
| 538 | 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… |
| 539 | 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. |
| 541 | D.4.5 Sample decimation Table D.3 — Example of filtering and decimation |
| 542 | D.4.6 Computation and Storage of the Difference Data D.4.6.1 General |
| 543 | 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 |
| 544 | 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 |
| 545 | Table D.4 — Huffman table # 1 Table D.5 — Huffman table # 2 D.4.7.4.3 Huffman tables without Table Mode Switch |
| 546 | Table D.6 — Alignment of byte oriented data values and Huffman code bits D.4.7.4.4 Huffman Tables with Table Mode Switch |
| 547 | Table D.7 — Alignment of byte oriented data values and Huffman code bits |
| 548 | 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 |
| 549 | D.4.7.6 Definition of the Default SCP-ECG Huffman table Table D.9 — Default SCP-ECG Huffman table |
| 550 | 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 |
| 551 | D.4.8.3.3 Second differences D.4.8.4 Reconstitution of decimated samples |
| 552 | Table D.10 — Example of decimation and reconstitution of 100 samples |
| 553 | 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 |
| 554 | D.4.8.8 Default SCP-ECG Decompression Parameters D.4.8.9 Default Method for Interpolation of decimated samples |
| 555 | D.4.8.10 Default Method for Three Sample Point Moving Average |
| 556 | D.5 Numerical examples for SCP-ECG data compression D.5.1 Example 1 |
| 557 | Table D.11 — Data obtained during SCP-ECG high compression |
| 558 | D.5.2 Example 2 Table D.12 — SCP-ECG pure redundancy reduction |
| 559 | D.6 Test set of ECGs used for “high” compression and decompression errors assessment |
| 560 | Table D.13 — Test set for error verification of SCP-ECG high compression methods |
| 561 | Figure D.7 — ECG for the example data (lead V1 to V6) |
| 562 | 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 |
| 563 | D.7.5 ECG compression methodology in brief |
| 565 | Annex E (informative) Cross-references to other ECG standards E.1 General E.2 Lead identification codes E.3 Universal Interpretation Statement codes |
| 566 | Table E.1 — Snapshot of the Interpretation statements codes and acronyms cross-reference list provided in the form of a set of Excel tables |
| 568 | 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 |
| 570 | Annex G (informative) Glossary |
| 572 | Annex H (informative) Revision History |
| 575 | Bibliography |
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