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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

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