YY/T 1944-2024Particular specification for medical X-ray high voltage generator (English PDF)
医用X射线高压发生器专用技术条件
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 29, 2024
Implementation date
April 15, 2026
Scope
YY/T 1944-2024 is the English-translated version of 医用X射线高压发生器专用技术条件.
YY/T 1944-2024 is the Chinese standard "Particular specification for medical X-ray high voltage generator". Its scope clause reads: This document specifies the requirements for medical X-ray high voltage generators (hereinafter referred to as high voltage generators) and describes the corresponding test methods.
This document applies to high voltage generators for medical X-ray generating devices, including but not limited to high voltage generators integrated with X-ray tubes. Life tool. Its clauses include terms and definitions.
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Document preview — YY/T 1944-2024
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C43
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Categories
- 5 Requirement
- 5.1 Working conditions
- 5.2 Product performance
- 5.3 Limitation of voltage, current or energy
- 5.4 Leakage Current
- 5.5 Dielectric strength
- 5.6 Limitation of radiated output
- 5.7 Safety measures to prevent excessive radiation output
- 5.8 Loading Factor Range
- 5.9 Electromagnetic compatibility
- 5.10 Environmental testing
- 5.11 Security
- 6 Test methods
- 6.1 Working conditions
- 6.2 Test methods
- 6.3 Limitation of voltage, current or energy
- 6.4 Leakage Current
- 6.5 Dielectric strength
- 6.6 Limitation of radiated output
- 6.7 Safety measures against excessive radiation output
- 6.8 Loading Factor Range
- 6.9 Electromagnetic compatibility
- 6.10 Environmental test
- 6.11 Security
1 Scope
This document specifies the requirements for medical X-ray high voltage generators (hereinafter referred to as high voltage generators) and describes the corresponding test methods.
This document applies to high voltage generators for medical X-ray generating devices, including but not limited to high voltage generators integrated with X-ray tubes.
Life tool.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB 9706.103 Medical electrical equipment Part 1-3.General requirements for basic safety and essential performance Collateral standard. Diagnostic X
Radiation protection of radiation equipment
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Requirements and tests definedterms)
3 Terms and definitions
The terms and definitions defined in GB 9706.1, GB 9706.103, YY 9706.102, IEC TR60788 and the following apply to this document.
Note. According to the definition in GB 9706.103, unless otherwise specified, in this special standard.
The X-ray tube voltage value refers to the peak voltage, ignoring instantaneous changes;
The X-ray tube current value refers to the average value.
3.1 Electric power
During the specified loading time, the power applied by the high voltage generator to the X-ray tube is equal to the coefficient of the X-ray tube voltage waveform, the X-ray
The product of the line tube voltage and the X-ray tube current.
P=fUI
Where.
P ---Electric power;
f --- coefficient dependent on the X-ray tube voltage waveform, selected as follows.
a) Six-peak high voltage generator f=0.95, or b) twelve-peak high voltage generator or constant voltage high voltage generator f=1.00, or c) For other X-ray high voltage generators, select the most suitable value according to the waveform of the X-ray tube voltage and give the selected value.
illustrate;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
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YY/T 1944-2024
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