IEC TR 62926:2019提供了自适应外射束放射治疗系统（AEBRS）的安全集成和操作指南，用于分次移动的刚性靶体积，其中所需的设备可以从一个或多个制造商处采购。特别是，它提出了帮助确保患者、操作者、其他人和附近敏感设备的安全集成和操作的指南。在本文件中，词语“系统”在下文中用于指代AEBRS。 本文件规定了制造商或负责组织的安全指南，这些制造商或组织集成了用于局部移动刚性靶体积的AEBR。如果一个负责任的组织集成了AEBRS，那么它将扮演制造商的角色，并在本文档中被称为制造商。本文件包括在风险分析期间至少考虑的分数内移动刚性靶体积和危害的AEBR参考模型。 尽管目标体积和桨可以在运动期间变形，但是响应于目标体积的变形的适配超出了本文档的范围。范围仅限于表现出分数内运动（平移和旋转）的刚性靶体积。虽然本文件中讨论了技术危害，但提醒负责组织，在确定临床可用性和审查治疗参数变更时，应始终采用临床判断。 本文件没有具体说明文件中提到的每种危害的危害缓解措施；然而，条款4和5中给出了一些缓解措施作为示例。本文件中的所有指南旨在根据通用标准IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012实施，特别注意IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012的4.2。

IEC TR 62926:2019 provides guidelines for safe integration and operation of an adaptive external-beam RADIOTHERAPY system (AEBRS) for intra-fractionally moving rigid TARGET VOLUMEs, where required equipment can be sourced from one or several MANUFACTURERs. In particular it addresses guidelines to help ensure safe integration and operation for the PATIENT, OPERATOR, other persons and sensitive devices in the vicinity. In this document, the word “system” is hereafter used to refer to an AEBRS.
This document specifies the safety guidelines for a MANUFACTURER or RESPONSIBLE ORGANIZATION who integrates the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs. If a RESPONSIBLE ORGANIZATION integrates an AEBRS, then it takes the role of MANUFACTURER and will be referred to as a MANUFACTURER throughout this document.
This document includes reference models of the AEBRS for intra-fractionally moving rigid TARGET VOLUMEs and HAZARDs which, at a minimum, are considered during the RISK ANALYSIS.
Although TARGET VOLUMES and OARs can deform during motion, adaptations in response to deformations of the TARGET VOLUME are out of the scope of this document. The scope is limited to rigid TARGET VOLUMEs exhibiting intra-fractional movements, both translational and rotational. While technical HAZARDs are discussed in this document, the RESPONSIBLE ORGANIZATION is reminded that clinical judgement is always employed when determining clinical usability and reviewing TREATMENT PARAMETER changes.
This document does not specifically address HAZARD mitigations for each of the HAZARDs mentioned in the document; however, some mitigations are given as examples in Clauses 4 and 5. All guidelines in this document are intended to be implemented in accordance with the general standard IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, with special attention to 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.