IEC 60601-2-68:2025

Overview

IEC 60601-2-68:2025 is an international standard developed by the International Electrotechnical Commission (IEC) that specifies particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy (IGRT) equipment. Targeting equipment used in conjunction with electron accelerators, light ion beam therapy systems, and radionuclide beam therapy equipment, this standard provides guidance for manufacturers and healthcare professionals to ensure effective and safe operation of X-ray IGRT systems. The scope includes kilovoltage (kV) and megavoltage (MV) X-ray imaging devices used for IGRT, focusing on their integration with external beam equipment (EBE), equipment communication, risk management, and operational safeguards.

Key Topics

• Basic Safety and Essential Performance: The standard defines minimum requirements for protecting patients and operators from electrical, mechanical, and radiation-related hazards pertaining to IGRT X-ray equipment.
• System Integration: IEC 60601-2-68:2025 covers the safety and communication protocols between X-ray IGRT devices and external beam equipment, whether these components are physically attached or merely co-located within a radiation-shielded area.
• Risk Mitigation: Procedures are outlined to address the risks of over-reliance on automated IGRT corrections, emphasizing the need for interactive user interfaces and quality assurance.
• Applicability: The standard is applicable to offline, online, and real-time X-ray IGRT, as well as combinations of IGRT systems with other medical electrical equipment (MEE), without redundant testing for shared requirements (e.g., patient positioning systems).
• Quality Assurance and Testing: Requirements include type tests and site tests to ensure safety and performance during both manufacturing and installation. The standard stresses routine quality assurance, calibration, and performance evaluations carried out by qualified professionals.
• Exclusions: General CT scanners, radiography, and radioscopy X-ray equipment not used specifically for IGRT are outside the scope unless used in the same room for IGRT purposes.

Applications

• Cancer Radiotherapy Centers: Ensures that X-ray IGRT equipment used with external beams in radiotherapy meets internationally recognized safety and performance benchmarks, improving patient outcomes and supporting precision treatment.
• Medical Device Manufacture: Guides manufacturers in designing, testing, and certifying integrated radiotherapy imaging systems that comply with global regulatory and safety requirements.
• System Installation and Maintenance: Provides detailed criteria for installers and service providers, ensuring proper equipment setup, documentation, and ongoing maintenance in line with safety recommendations.
• Clinical Workflows: Supports clinical teams in integrating IGRT devices into workflow, reducing risks related to patient alignment and real-time anatomical changes before and during radiation treatment.
• Regulatory Compliance: Assists healthcare organizations and device manufacturers in fulfilling the relevant legal and regulatory obligations in regions that recognize IEC standards.

Related Standards

Compliance with IEC 60601-2-68:2025 involves alignment with several other key standards within the medical electrical equipment field, including:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-2-1: Particular requirements for electron accelerators in radiotherapy.
• IEC 60601-2-44: Standards for X-ray equipment used in computed tomography.
• IEC 60601-2-64: Requirements for light ion beam therapy equipment.
• IEC 60976 / IEC TR 60977: Functional performance requirements for medical electron accelerators.
• IEC 60601-1-3 / IEC 60601-1-6: Standards covering radiation protection and usability aspects.
• IEC 62083 / IEC 62274: Safety of radiotherapy treatment planning and record/verify systems.

By referencing and integrating applicable sections of these related standards, IEC 60601-2-68:2025 ensures a comprehensive safety and performance approach for advanced IGRT systems in radiotherapy environments.

Keywords: IEC 60601-2-68:2025, X-ray IGRT, image-guided radiotherapy, external beam equipment, radiation safety, medical electrical equipment standard, radiotherapy equipment compliance, quality assurance, system integration, medical device regulation.