
OCCUPATION AND HEALTH ›› 2026, Vol. 42 ›› Issue (1): 139-144.
• Overview • Previous Articles
GU Haoyan1,2, JIANG Wenwen1,2, YU Runqiu2, FENG Zechen2, BAI Bin2, MA Yongzhong1,2(
)
Received:2025-11-29
Revised:2025-12-19
Online:2026-01-01
Published:2026-02-03
CLC Number:
GU Haoyan, JIANG Wenwen, YU Runqiu, FENG Zechen, BAI Bin, MA Yongzhong. Patient protection issues and countermeasures in superficial X-ray radiotherapy. [J]OCCUPATION AND HEALTH, 2026, 42(1): 139-144.
| 序号 | 标准名称 | 适用范围和主要技术内容 | 与患者防护的关联性 |
|---|---|---|---|
| 1 | GB 9706.228—2020《医用电气设备 第2-28部分:医用诊断X射线管组件的基本安全和基本性能专用要求》[ | 规定了医用X射线管(治疗设备核心部件)的技术指标、测试方法及基本安全性能要求,从源头上保障设备的安全性和有效性。 | 聚焦于设备组件层面的安全和性能,属于操作安全的基础要求,并未涉及患者在接受治疗时的临床防护操作规范。 |
| 2 | GB 9706.208—2021《医用电气设备 第2-8部分:能量为10 kV至1 MV治疗X射线设备的基本安全和基本性能专用要求》[ | 规定了医用X射线管组件及治疗X射线设备的基本安全和基本性能要求,确保设备在电气安全、辐射安全等基础层面符合标准。从设备制造和源头上保障了浅层X射线治疗机的基本安全性能,为治疗提供了安全可靠的硬件基础。 | 聚焦于设备本身的安全和性能,局限于设备操作层面的安全要求。并未涉及患者治疗过程中的临床防护操作技术,如如何为患者实施屏蔽防护等,无法直接指导临床中的患者靶外防护。 |
| 3 | GB/T 13797—2023《医用X射线管通用技术条件》[ | 规定了医用X射线管的各项技术指标和测试方法,医用X射线管作为浅层X射线治疗机等医用X射线设备的射线源,装配在X射线管组件中,是浅层治疗设备的核心部件,供医用X射线机配套使用,明确了有关X射线管球性能试验和X射线治疗机操作中的安全问题 | 局限于X射线管的性能和操作安全问题,不涉及患者防护。 |
| 4 | GBZ 131—2017《医用X射线治疗放射防护要求》[ | 规定了治疗机泄漏辐射、治疗室防护、性能检测和操作要求;提出了放射治疗防护的总体框架,包括治疗计划优化、安全操作和质量保证。 | 未提供患者防护操作的基本原则、技术要点和效果验证等关键要素。而技术人员在浅层X射线治疗仍缺乏针对患者靶外防护的有效指导,易产生防护冷点或纰漏。 |
| 5 | GBZ 121—2020《放射治疗放射防护要求》[ | 明确提出了放疗患者靶外防护的原则(“4.3最优化要求”),确立了“靶区精准剂量、靶外组织保护”的基本目标,要求优化过程涵盖治疗处方、操作规程和质量控制等。 | 作为通用性标准,未针对浅层X射线治疗(能量低、散射大)的特异性给出具体的患者防护操作技术规范或细则,无法满足其特殊的防护需求。 |
| 序号 | 标准名称 | 适用范围和主要技术内容 | 与患者防护的关联性 |
|---|---|---|---|
| 1 | GB 9706.228—2020《医用电气设备 第2-28部分:医用诊断X射线管组件的基本安全和基本性能专用要求》[ | 规定了医用X射线管(治疗设备核心部件)的技术指标、测试方法及基本安全性能要求,从源头上保障设备的安全性和有效性。 | 聚焦于设备组件层面的安全和性能,属于操作安全的基础要求,并未涉及患者在接受治疗时的临床防护操作规范。 |
| 2 | GB 9706.208—2021《医用电气设备 第2-8部分:能量为10 kV至1 MV治疗X射线设备的基本安全和基本性能专用要求》[ | 规定了医用X射线管组件及治疗X射线设备的基本安全和基本性能要求,确保设备在电气安全、辐射安全等基础层面符合标准。从设备制造和源头上保障了浅层X射线治疗机的基本安全性能,为治疗提供了安全可靠的硬件基础。 | 聚焦于设备本身的安全和性能,局限于设备操作层面的安全要求。并未涉及患者治疗过程中的临床防护操作技术,如如何为患者实施屏蔽防护等,无法直接指导临床中的患者靶外防护。 |
| 3 | GB/T 13797—2023《医用X射线管通用技术条件》[ | 规定了医用X射线管的各项技术指标和测试方法,医用X射线管作为浅层X射线治疗机等医用X射线设备的射线源,装配在X射线管组件中,是浅层治疗设备的核心部件,供医用X射线机配套使用,明确了有关X射线管球性能试验和X射线治疗机操作中的安全问题 | 局限于X射线管的性能和操作安全问题,不涉及患者防护。 |
| 4 | GBZ 131—2017《医用X射线治疗放射防护要求》[ | 规定了治疗机泄漏辐射、治疗室防护、性能检测和操作要求;提出了放射治疗防护的总体框架,包括治疗计划优化、安全操作和质量保证。 | 未提供患者防护操作的基本原则、技术要点和效果验证等关键要素。而技术人员在浅层X射线治疗仍缺乏针对患者靶外防护的有效指导,易产生防护冷点或纰漏。 |
| 5 | GBZ 121—2020《放射治疗放射防护要求》[ | 明确提出了放疗患者靶外防护的原则(“4.3最优化要求”),确立了“靶区精准剂量、靶外组织保护”的基本目标,要求优化过程涵盖治疗处方、操作规程和质量控制等。 | 作为通用性标准,未针对浅层X射线治疗(能量低、散射大)的特异性给出具体的患者防护操作技术规范或细则,无法满足其特殊的防护需求。 |
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