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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.60 Therapy equipment>BS EN IEC 60601-2-68:2025 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
immediate downloadReleased: 2025-04-28
BS EN IEC 60601-2-68:2025 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

BS EN IEC 60601-2-68:2025

Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

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Standard number:BS EN IEC 60601-2-68:2025
Pages:82
Released:2025-04-28
ISBN:978 0 539 15087 2
Status:Standard

BS EN IEC 60601-2-68:2025 - Elevating the Standards of Medical Electrical Equipment

In the ever-evolving world of medical technology, ensuring the safety and performance of equipment is paramount. The BS EN IEC 60601-2-68:2025 standard is a crucial document that sets the benchmark for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment. This standard is specifically designed for use with electron accelerators, light ion beam therapy equipment, and radionuclide beam therapy equipment, making it an indispensable resource for professionals in the field of medical radiotherapy.

Comprehensive Coverage and Detailed Insights

Spanning 82 pages, this standard provides an in-depth exploration of the requirements necessary to ensure that medical electrical equipment used in radiotherapy is both safe and effective. Released on April 28, 2025, it reflects the latest advancements and regulatory expectations in the field. The document is identified by the ISBN 978 0 539 15087 2, ensuring its authenticity and ease of reference.

Why BS EN IEC 60601-2-68:2025 is Essential

The importance of this standard cannot be overstated. It addresses the critical aspects of safety and performance, which are vital for protecting both patients and healthcare providers. By adhering to the guidelines set forth in this document, medical facilities can ensure that their equipment operates within the safest parameters, thereby minimizing risks associated with radiotherapy procedures.

Key Features of the Standard:

  • Basic Safety Requirements: The standard outlines the fundamental safety measures that must be in place to protect patients and operators from potential hazards associated with X-ray-based radiotherapy equipment.
  • Essential Performance Criteria: It specifies the performance benchmarks that equipment must meet to ensure effective and reliable treatment outcomes.
  • Compatibility with Advanced Technologies: The standard is designed to be applicable to the latest technologies in electron accelerators, light ion beam therapy, and radionuclide beam therapy, ensuring its relevance in modern medical practices.
  • Comprehensive Guidelines: Detailed instructions and guidelines are provided to assist manufacturers and healthcare providers in implementing the standard effectively.

Who Should Use This Standard?

This standard is an invaluable resource for a wide range of professionals in the medical field, including:

  • Medical Equipment Manufacturers: To ensure that their products meet the highest safety and performance standards.
  • Healthcare Providers: To maintain compliance with regulatory requirements and ensure the safety of their patients.
  • Regulatory Bodies: To establish a consistent framework for evaluating the safety and performance of radiotherapy equipment.
  • Medical Physicists and Engineers: To understand the technical requirements and ensure the optimal functioning of radiotherapy equipment.

Stay Ahead with the Latest Standards

In a field where technology and regulations are constantly evolving, staying updated with the latest standards is crucial. The BS EN IEC 60601-2-68:2025 standard provides the most current guidelines, ensuring that your practices are aligned with the latest safety and performance expectations.

By integrating this standard into your operations, you not only enhance the safety and efficacy of your radiotherapy equipment but also demonstrate a commitment to excellence and patient care. This standard is not just a document; it is a pathway to achieving the highest levels of safety and performance in medical radiotherapy.

Conclusion

The BS EN IEC 60601-2-68:2025 standard is a critical tool for anyone involved in the design, manufacture, or use of X-ray-based image-guided radiotherapy equipment. Its comprehensive guidelines ensure that equipment meets the necessary safety and performance criteria, ultimately leading to better patient outcomes and enhanced trust in medical technologies.

Embrace the future of medical radiotherapy with confidence by adhering to the standards set forth in this essential document. Equip yourself with the knowledge and guidelines necessary to navigate the complexities of modern medical equipment safety and performance.

DESCRIPTION

BS EN IEC 60601-2-68:2025


This standard BS EN IEC 60601-2-68:2025 Medical electrical equipment is classified in these ICS categories:
  • 11.040.60 Therapy equipment
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 manufacturer's 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.
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