本文件提供了自适应外束放射治疗系统（AEBRS）的安全集成和操作指南，该系统可用于局部移动刚性靶区，所需设备可从一家或多家制造商处采购。特别是，它提出了指导方针，以帮助确保患者、操作员、其他人员和附近敏感设备的安全集成和操作。在本文件中，“系统”一词在下文中用于指AEBRS。 本文件规定了制造商或负责组织的安全指南，这些制造商或负责组织将AEBR集成到内部部分移动刚性目标体积中。如果责任组织集成了AEBRS，则其将扮演制造商的角色，并在本文件中被称为制造商。 本文件包括AEBR的参考模型，用于局部移动刚性目标体积和危险，风险分析过程中至少会考虑这些模型。 虽然目标体积和桨在运动过程中可能会变形，但对目标体积变形的适应不在本文档的范围内。该范围仅限于显示平移和旋转部分内运动的刚性目标体积。虽然本文件讨论了技术危害，但提醒责任机构，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。 本文件未具体说明文件中提到的每种危害的危害缓解措施；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应按照通用标准IEC 60601-1:2005和IEC 60601-1:2005/AMD1:2012执行，特别注意IEC 60601-1:2005和IEC 60601-1:2005/AMD1:2012中的4.2。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document 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.All current amendments available at time of purchase are included with the purchase of this document.