EUROLAB laboratory provides testing and compliance services within the scope of EN 60601-2 standard. This part of the EN 60601 standard applies to the basic safety and basic performance of electron accelerators in the range of 1 MeV to 50 MeV used for the treatment of patients, hereinafter referred to as ME equipment.
Electron accelerators used in the treatment of patients are always ME devices, but there are times when they are referred to in this document as external barn equipment (EBE). The use of EBE does not remove the requirements placed on ME equipment, but is to clarify that the ME equipment discussed is the EBE and not some other ME equipment that may be part of the system configuration.
Including type testing and ground testing, this particular standard applies to the manufacture and certain aspects of installation and equipment involved in electron accelerators used to increase the precision, accuracy and volumetric targeting of treatment delivery intended for radiotherapy in medical practice.
It transmits a radiation beam of X-radiation or electron radiation in the range of 1 MeV to 50 MeV with rated energy under normal conditions and in normal use, including systems where the selection and display of treatment parameters can be automatically controlled by programmable electronic subsystems (PESS).
The EN 60601-2 standard consists of the following parts:
EN 60601-2-2 - Medical electrical equipment - Part 2-2: Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency surgical accessories
EN 60601-2-3 - Medical electrical equipment - Part 2-3: Special requirements for basic safety and basic performance of shortwave therapy equipment
EN 60601-2-4 - Medical electrical equipment - Part 2-4: Special requirements for basic safety and basic performance of cardiac defibrillators
EN 60601-2-5 - Medical electrical equipment - Part 2-5: Special requirements for basic safety and basic performance of ultrasonic physiotherapy equipment
EN 60601-2-6 - Medical electrical equipment - Part 2-6: Special requirements for basic safety and basic performance of microwave therapy equipment
EN 60601-2-7 - Medical electrical equipment - Part 2-7: Specific requirements for the safety of high voltage generators of Diagnostic X-ray Generators
EN 60601-2-8 - Medical electrical equipment - Part 2-8: Special requirements for basic safety and basic performance of therapeutic X-ray equipment operating in the range of 10 kV to 1 MV
EN 60601-2-9 - Medical electrical equipment - Part 2-9: Specific requirements for the safety of patient contact desometers used in radiotherapy with electrically coupled radiation detectors
EN 60601-2-10 - Medical electrical equipment - Part 2-10: Special requirements for basic safety and basic performance of nerve and muscle stimulators
EN 60601-2-11 - Medical electrical equipment - Part 2-11. Special requirements for basic safety and basic performance of gamma-ray therapy equipment
EN ISO 80601-2-12 - Medical electrical equipment - Part 2-12. Specific requirements for essential safety and essential performance of critical care ventilators
EN 60601-2-13 - Medical electrical equipment - Part 2-13: Specific requirements for basic safety and basic performance of an anesthetic workstation
EN 60601-2-14 - Medical electrical equipment - Part 2-14: Specific requirements for the safety of electroconvulsive therapy devices
EN 60601-2-15 - Medical electrical equipment - Part 2-15: Specific requirements for the safety of capacitor discharge X-ray generators
EN 60601-2-16 - Medical electrical equipment - Part 2-16: Special requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment
EN 60601-2-17 - Medical electrical equipment - Part 2-17: Specific requirements for post-gamma-ray safety of remotely controlled auto-driven equipment
EN 60601-2-18 - Medical electrical equipment - Part 2-18: Special requirements for basic safety and basic performance of endoscopic equipment
EN 60601-2-19 - Medical electrical equipment - Part 2-19: Special requirements for basic safety and basic performance of infant incubators
EN 60601-2-20 - Medical electrical equipment - Part 2-20: Special requirements for basic safety and basic performance of infant carrier incubators
EN 60601-2-21 - Medical electrical equipment - Part 2-21: Special requirements for basic safety and basic performance of infant radiant warmers
EN 60601-2-22 - Medical electrical equipment - Part 2-22: Special requirements for basic safety and basic performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
EN 60601-2-23 - Medical electrical equipment - Part 2-23: Special requirements for basic safety and basic performance of transcutaneous partial pressure monitoring equipment
EN 60601-2-24 - Medical electrical equipment - Part 2-24: Special requirements for basic safety and basic performance of infusion pumps and controllers
EN 60601-2-25 - Medical electrical equipment - Part 2-25: Special requirements for basic safety and basic performance of electrocardiographs
EN 60601-2-26 - Medical electrical equipment - Part 2-26: Special requirements for basic safety and basic performance of electroencephalographs
EN 60601-2-27 - Medical electrical equipment - Part 2-27: Special requirements for basic safety and basic performance of electrocardiographic monitoring equipment
EN 60601-2-28 - Medical electrical equipment - Part 2-28: Special requirements for basic safety and basic performance of X-ray tube assemblies for medical diagnostics
EN 60601-2-29 - Medical electrical equipment - Part 2-29: Special requirements for basic safety and basic performance of radiotherapy simulators
EN 60601-2-30 - Medical electrical equipment - Part 2-30: Special requirements for basic safety and basic performance of automatic non-invasive blood pressure monitors
EN 60601-2-31 - Medical electrical equipment - Part 2-31: Special requirements for basic safety and basic performance of external pacemakers with internal power supply
EN 60601-2-32 - Medical electrical equipment - Part 2-32: Specific requirements for the safety of associated X-ray equipment
EN 60601-2-33 - Medical electrical equipment - Part 2-33: Special requirements for basic safety and basic performance of magnetic resonance equipment for medical diagnostics
EN 60601-2-34 - Medical electrical equipment - Part 2-34: Special requirements for basic safety and basic performance of invasive blood pressure monitoring equipment
EN 60601-2-35 - Medical electrical equipment. Special requirements for the basic safety and basic performance of heating devices that use blankets, pads and mattresses and are intended for heating in medical use
EN 60601-2-36 - Medical electrical equipment. Special requirements for the essential safety and essential performance of in vitro induced lithotripsy
EN 60601-2-37 - Medical electrical equipment - Part 2-37: Special requirements for basic safety and basic performance of ultrasonic medical diagnostic and monitoring equipment
EN 60601-2-38 - Medical electrical equipment - Part 2-38: Specific requirements for the safety of electrical hospital beds
EN 60601-2-39 - Medical electrical equipment - Part 2-39: Special requirements for basic safety and basic performance of peritoneal dialysis equipment
EN 60601-2-40 - Medical electrical equipment - Part 2-40: Specific requirements for the safety of electromyographs and evoked response equipment
EN 60601-2-41 - Medical electrical equipment -- Part 2-41: Special requirements for the basic safety and basic performance of surgical luminaires and luminaires for diagnosis
EN 60601-2-43 - Medical electrical equipment - Part 2-43: Special requirements for basic safety and basic performance of X-ray equipment for interventional procedures
EN 60601-2-44 - Medical electrical equipment - Part 2-44: Special requirements for basic safety and basic performance of X-ray equipment for computed tomography
EN 60601-2-45 - Medical electrical equipment - Part 2-45: Special requirements for basic safety and basic performance of mammographic X-ray equipment and mammographic stereotactic devices
EN 60601-2-46 - Medical electrical equipment - Part 2-46: Special requirements for basic safety and basic performance of operating tables
EN 60601-2-47 - Medical electrical equipment - Part 2-47: Special requirements for basic safety and basic performance of ambulatory electrocardiographic systems
EN 60601-2-49 - Medical electrical equipment - Part 2-49: Special requirements for basic safety and basic performance of multifunctional patient monitoring equipment
EN 60601-2-50 - Medical electrical equipment - Part 2-50: Special requirements for basic safety and basic performance of infant phototherapy equipment
EN 60601-2-51 - Medical electrical equipment - Part 2-51: Recording and analysis of single-channel and multi-channel electrocardiographs Specific requirements for safety, including basic performance
EN 60601-2-52 - Medical electrical equipment -- Part 2-52: Special requirements for basic safety and basic performance of medical beds
EN 60601-2-54 - Medical electrical equipment - Part 2-54: Special requirements for basic safety and basic performance of X-ray equipment for radiography and radioscopy
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