GB 9706.103-2020Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment (English PDF)
医用电气设备 第1-3部分:基本安全和基本性能的通用要求 并列标准:诊断X射线设备的辐射防护
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Mandatory
Issue date
December 24, 2020
Implementation date
May 1, 2023
Scope
GB 9706.103-2020 is the English-translated version of 医用电气设备 第1-3部分:基本安全和基本性能的通用要求 并列标准:诊断X射线设备的辐射防护.
GB 9706.103-2020 is the Chinese standard "Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment".
Its scope clause reads: 1:1 Scope This part of GB 9706 applies to the basic safety of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems): Full and basic performance: This section applies to X-ray equipment and its components that diagnose, plan, or guide medical operations through patient radiological images: 1:2 Purpose The purpose of this collateral standard is to supplement the general standard by stipulating general requirements and serve as the basis for formulating specific standards: The purpose of this collateral standard is to establish general requirements for X-ray radiation protection in X-ray equipment: It is to make patients, operators, work The radiation received by personnel and the public is kept at a reasonable level as low as possible without endangering the benefits of the radiation process: For this union The general requirements specified by the listed standards, other special standards may use appropriate values and/or measurement methods: Implement general requirements or adopt special standards In the risk management process, reasonable reasons should be explained: This collateral standard only considers radiation protection related to X-ray radiation: For another important aspect of radiation protection, that is, the requirements for the control of electrical energy required to generate X-ray radiation are in GB 9706:1 and related equipment: In the dedicated standards for the safety and basic performance of the equipment: 1:3 Related standards 1:3:1 GB 9706:1 For ME equipment and ME systems, this collateral standard is a supplement to GB 9706:1: When referring to GB 9706:1 or this collateral standard, whether alone or in combination, the following conventions are used: --- "General Standard" refers to GB 9706:1; --- "This Parallel Standard" refers to GB 9706:103; --- "This standard" refers to the combination of the general standard and this parallel standard: 1:3:2 Specific standards The requirements in the specific standards take precedence over the corresponding requirements in this parallel standard:. Its clauses include scope, purpose and related standards.
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Document preview — GB 9706.103-2020
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 43
- Replacing
- GB 9706.12-1997
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- 1 Scope, purpose and related standards
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 5 Marking, marking and documentation of ME equipment
- 6 Radiation management
- 7 Radiation quality
- 8 Limitation of X-ray beam range and the relationship between X-ray field and image receiving area
- 9 Focal distance
- 10 Attenuation of the radiation beam between the patient and the image receiver
- 11 Protection from residual radiation
- 12 *Protection against leakage of radiation
- 13 Protection against stray radiation
- Appendix A (informative appendix) General guidelines and compilation instructions
- Appendix B (informative appendix) R'10 and R'20 number system values in GB/T 19764
- References
1 Scope, purpose and related standards
1:1 Scope
This part of GB 9706 applies to the basic safety of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems):
Full and basic performance:
This section applies to X-ray equipment and its components that diagnose, plan, or guide medical operations through patient radiological images:
1:2 Purpose
The purpose of this collateral standard is to supplement the general standard by stipulating general requirements and serve as the basis for formulating specific standards:
The purpose of this collateral standard is to establish general requirements for X-ray radiation protection in X-ray equipment: It is to make patients, operators, work
The radiation received by personnel and the public is kept at a reasonable level as low as possible without endangering the benefits of the radiation process: For this union
The general requirements specified by the listed standards, other special standards may use appropriate values and/or measurement methods: Implement general requirements or adopt special standards
In the risk management process, reasonable reasons should be explained:
This collateral standard only considers radiation protection related to X-ray radiation:
For another important aspect of radiation protection, that is, the requirements for the control of electrical energy required to generate X-ray radiation are in GB 9706:1 and related equipment:
In the dedicated standards for the safety and basic performance of the equipment:
1:3 Related standards
1:3:1 GB 9706:1
For ME equipment and ME systems, this collateral standard is a supplement to GB 9706:1:
When referring to GB 9706:1 or this collateral standard, whether alone or in combination, the following conventions are used:
--- "General Standard" refers to GB 9706:1;
--- "This Parallel Standard" refers to GB 9706:103;
--- "This standard" refers to the combination of the general standard and this parallel standard:
1:3:2 Specific standards
The requirements in the specific standards take precedence over the corresponding requirements in this parallel standard:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB 9706:1-2020 Medical electrical equipment Part 1: General requirements for basic safety and basic performance (IEC 60601-1:
2012, MOD)
GB/T 13797 | GB/T 10151 | GB 9706.5 | GB/T 9706.266 | GB 9706.255 | GB 9706.222 | […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 56 pages — is available in the English PDF.
Referenced standards
Normative references
GB 9706 · IEC 60601
Cited by
- YY/T 0479-2026Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
- YY/T 1625-2026Particular specifications for mobile X-ray equipment for computed tomography
- GB/T 19042.7-2025Evaluation and routine testing in medical imaging departments - Part 3-7: X-ray equipment for dental cone beam computed tomography imaging performance acceptance and constancy tests
- YY/T 0062.1-2024Medical electrical equipment - Diagnostic X-rays - Part 1: Determination of quality equivalent filtration and permanent filtration
- YY/T 0063-2024Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
- YY/T 1766.4-2024Image quality evaluation methods for computed tomography scanners - Part 4: Evaluation of imaging performance under automatic exposure control
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
GB 9706.15-2008 — Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
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