YY 0782-2010Medical electrical equipment - Part 2-51: Particular requirements for the safety and essential performance of recording and analysing single channel and multichannel electrocardiographs (English PDF)
医用电气设备 第2-51部分：记录和分析型单道和多道心电图机安全和基本性能专用要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY 0782-2010 is the English-translated version of 医用电气设备 第2-51部分：记录和分析型单道和多道心电图机安全和基本性能专用要求.
YY 0782-2010 is the Chinese standard "Medical electrical equipment - Part 2-51: Particular requirements for the safety and essential performance of recording and analysing single channel and multichannel electrocardiographs".
Its scope clause reads: In addition to the following, the common standards in this chapter apply. Its clauses include scope and purpose.
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Document preview — YY 0782-2010
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C39
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1 Scope and purpose
- 1.1 * Range
- 1.2 Objective
- 1.3 Specific Standard
- 2 Terms and definitions
- 4 General test requirements
- 6 Identification, marking and documents
- 7 50 Operating data accuracy
- 51 protection dangerous output
- 56 26 components and subassemblies
- Annex L (normative) --- standard reference publications mentioned in
- Annex AA (informative) Theoretical and General Guidelines
- Appendix BB (informative) electrode, the electrode position, definition and color code
- Annex CC (informative) leads the definition of leads (Definitions In addition to the 51.101)
- Appendix DD (informative) polarity of patient leads (Definitions In addition to the 51.101)
- Appendix FF (normative) Noise
- Appendix GG (normative) definitions and rules ECG
- Appendix HH (normative) Calibration and testing database
- Appendix II (Information Appendix) CTS test pattern
- References
- 101 According to Frank electrode position (see Table 101)
- 102 patients polar leads (see 51.101.1)
- 103 Weighted network and input impedance of the test pattern (see 51.101.2.2 and 51.102.1)
- 105 Table 114 Test E triangular wave (see 51.107.1.1.1)
- 106 input pulse signal (dashed line) and ECG response (solid line) (see 51.107.1.1.2)
- 109 test results rectangle coordinates (see. 51.108.4.1)
1 Scope and purpose
In addition to the following, the common standards in this chapter apply.
1.1 * Range
Addition.
This standard specifies the special safety requirements for recording and analyzing single channel and multi-channel ECG machine and the basic performance requirements. Single-channel and multi-channel heart
FIG electric machine has been defined in the 2.101,2.111,2.117,2.123,2.126, hereinafter referred to as devices. Such equipment may have been
Custody or unattended.
This special supplement standard GB 10793-2000.
1.2 Purpose
Alternative.
In addition to GB 10793-2000 in terms of security made some additional requirements beyond the specific purpose of the standard is to establish a close
For recording and analyzing single channel and multi-channel ECG machine safety and essential performance of special requirements.
The only requirements for particular application.
--- Type recording ECG;
--- ECG machine, ECG machine that is part of one of the other medical electrical equipment, such as exercise test system, if the ECG FIG machine is used to record the ECG and for diagnostic purposes;
--- ECG is used as the database management system of the output unit of the ECG machine, or place in the absence of a recording device as an output
ECG unit;
--- Analytical ECG machines, systems and computing equipment, which by electrocardiogram electronic data processing and pattern recognition approach
Measurement (such as intervals and amplitudes) and diagnostic instructions;
--- Having realized analytical analysis of patient ECG monitor ECG or other special part of ECG machine.
This standard does not apply to Holter ECG, invasive ECG, patient monitoring systems, and other high-resolution other than the above
ECG (electrocardiogram machine such as HIS bundle with late potential detection of ECG).
1.3 Specific Standard
Addition.
The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" and GB 10793-2000
"Medical electrical equipment - Part 2-25. ECG requirements for the safety."
YY 0782-2010/IEC 60601-2-51.2003 […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 129 pages — is available in the English PDF.
Referenced standards
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