IEC 60601-2-68-ed.2.0

Podrobné informace

Označení: IEC 60601-2-68-ed.2.0

Datum vydání: 04.02.2025

Stran: 155

Země: Mezinárodní technická norma

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Anotace

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturers providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be: • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with the new editions of the relevant standards: – IEC 60601-2-1:2020; – IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016; – IEC 60601-2-64:2014; b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE); c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION. LIEC 60601-2-68:2025 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE destines a etre utilises avec les APPAREILS DE RADIOTHERAPIE EXTERNES (EBE). Le present document couvre les aspects de securite des dispositifs dimagerie a rayonnement X sous kilotension (kV) et sous megatension (MV) integres dans une relation geometrique specifiee avec les EBE a des fins de RADIOTHERAPIE ASSISTEE PAR IMAGERIE MEDICALE. Il couvre les aspects de communication et les relations entre les APPAREILS DE RADIOTHERAPIE EXTERNES et les dispositifs dimagerie a rayonnement X fixes ou non directement fixes, mais presents dans la meme zone protegee contre le RAYONNEMENT que les APPAREILS DE RADIOTHERAPIE EXTERNES, et destines a etre utilises uniquement avec ces appareils. Le present document traite des APPAREILS DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE HORS LIGNE, EN LIGNE et EN TEMPS REEL. Il couvre les procedures de reduction du risque de confiance excessive envers le SYSTEME EBE X-IGRT. Par exemple, dans le cas dune RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE EN LIGNE, le FABRICANT fournit une interface interactive destinee a linteraction des utilisateurs avec la correction proposee par le systeme. Le present document ne sapplique pas aux TOMODENSITOMETRES, aux APPAREILS A RAYONNEMENT X pour la RADIOGRAPHIE et aux APPAREILS A RAYONNEMENT X pour la RADIOSCOPIE, qui ne sont pas concus pour etre utilises pour la RADIOTHERAPIE ASSISTEE PAR IMAGERIE MEDICALE. Les exigences soumises a lessai conformement a une autre norme peuvent etre identifiees par le fabricant. Lorsque ces exigences sont equivalentes, de nouveaux essais ne sont pas exiges, mais la conformite peut etre prouvee par les declarations de conformite ou les rapports dessai relatifs aux TOMODENSITOMETRES, aux APPAREILS A RAYONNEMENT X pour la RADIOGRAPHIE ou aux APPAREILS A RAYONNEMENT X pour les APPAREILS DE RADIOSCOPIE fournis par le fabricant. Lorsquun APPAREIL DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE est combine a un APPAREIL ELECTROMEDICAL, toutes les exigences communes a lAPPAREIL DE RADIOTHERAPIE A RAYONNEMENT X ASSISTEE PAR IMAGERIE MEDICALE et a lAPPAREIL ELECTROMEDICAL (par exemple, un POSITIONNEUR DE PATIENT) nont pas besoin detre soumises a lessai deux fois, mais peuvent etre admises comme ayant ete soumises a lessai par lAPPAREIL ELECTROMEDICAL. Le present document sapplique aux APPAREILS A RAYONNEMENT X