IEC TR 62926 pdf free download

IEC TR 62926 pdf free download.Medical electrical system – Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems for real-time adaptive radiotherapy.
4.2 Relationship between system configuration of an AEBRS, existing standards, and
this document
4.2.1 General
The RISK arising from the integration of equipment in an AEBRS should be addressed by the
MANUFACTURER and this should be done according to existing STANDARDS, where available. Irrespective of the system configuration of an AEBRS, IEC 60601-1 and its collaterals always apply. Particular standards may exist to cover equipment integrated in an AEBRS. Examples of such particular standards are IEC 60601-2-1 and IEC 60601-2-64 for EBE, IEC 60601-2-68 for MCF or a combination of MCF and MOE, and IEC 60601-2-33 and IEC 60601-2-44 for MDE.
This document provides further guidance in implementing 4.2 and Clause 14 from IEC 60601- 1:2005 and IEC 60601-1:2005/AMD1:2012.
The MANUFACTURER of an AEBRS should ask the MANUFACTURER of any MEE to be integrated to provide applicable conditions of interoperability and requirements for acceptability.
Mitigation of AEBRS RISKS is the responsibility of the integrating party, and the mitigation should be demonstrated by a completed Test Report Form for the IEC 60601-1 series of standards.
Compliance of the AEBRS can be documented by referencing the corresponding clauses or subclauses of existing standard(s) for the integrated devices.
NOTE 1 An example of MEES covered by particular standards in the IEC 60601 series is illustrated when assessing the RISK associated with an AEBRS using LIGHT ION BEAM equipment as an EBE and utilizing X-ray RADIOSCOPY as an MDE. IEC 60601-2-64:2014 applies to the EBE and IEC 60601 -2-68:2014 applies to the MDE and MCF.
NOTE 2 An example of an MEE not covered by IEC 60601 particular standards is illustrated when assessing the RISK associated with an AEBRS utilizing a 3D camera as MOE. The latter is not addressed by any of the standards in the IEC 60601-1 series.
Annexes A to C show examples of RISK MANAGEMENT of an AEBRSs as explained in 4.3.2.
4.2.2 Representative configurations of AEBRSs, their relationships to existing
standards, and this document
4.2.2.1 General
Representative configurations of AEBRSs, their relationships to existing standards and this document are described in the following subclauses. The dotted line in each figure indicates the function or EQUIPMENT covered by the standard cited in each of the following paragraphs and figures. This document covers the entire system as described by the series of examples.
4.2.2.2 Relationship with standards for MOTION DETECTION EQUIPMENT (MDE)
Figure 3 shows an example of an AEBRS incorporating MOE that are addressed by particular standards (e.g. IEC 60601-2-33 for MRI, IEC 60601-2-68 for x-IGRT).IEC TR 62926 pdf download.