医用电气系统.实时自适应放射治疗用自适应外束放射治疗系统的安全集成和操作指南

[中文适用范围]： 本文件提供了用于局部移动刚性目标体积@的自适应外束放射治疗系统（AEBRS）的安全集成和操作指南，其中所需设备可以从一个或多个制造商处采购。特别是，它提出了指导方针，以帮助确保患者@操作员@附近的其他人员和敏感设备的安全集成和操作。在这个文档中@这个词??系统??此后用于指代 AEBRS。本文件规定了集成 AEBRS 以进行点内移动刚性目标体积的制造商或责任组织的安全指南。如果责任组织集成了 AEBRS@，那么它就扮演了制造商的角色，并且在本文档中将被称为制造商。本文件包括用于局部移动刚性目标体积和危险的 AEBRS 参考模型，在风险分析过程中至少要考虑这些危险。尽管目标体积和 OAR 在 Motion@ 过程中可能会变形，但响应目标体积变形的调整超出了本文档的范围。范围仅限于表现出分数内运动@平移和旋转的刚性目标体积。虽然本文件中讨论了技术危险，但提醒责任组织在确定临床可用性和审查治疗参数变化时始终采用临床判断。本文件并未具体解决文件中提到的每种危险的危险缓解措施；然而，第 4 条和第 5 条中给出了一些缓解措施作为示例。本文件中的所有指南均旨在根据通用标准 IEC 60601-1:2005 和 IEC 60601-1:2005/AMD1:2012@ 以及特殊标准来实施。注意 IEC 60601-1:2005 和 IEC 60601-1:2005/AMD1:2012 的 4.2。 [外文原描述]： 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.