Medical electrical equipment. Medical electron accelerators. Functional performance characteristics

Medical electrical equipment. Medical electron accelerators. Functional performance characteristics

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What is BS EN 60976-Performance characteristics of the medical electron accelerator about?  

BS EN 60976 is a European standard on medical electrical equipment that discusses the performance characteristics of the medical electron accelerator to enhance the performance of the medical electron accelerators.  

BS EN 60976 applies to medical electron accelerators when used, for therapy purposes, in human medical practice.  

BS EN 60976 applies to medical electron accelerators which deliver a radiation beam of either X-radiation or Electron radiation with nominal energies in the range of 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s–1 and 1 Gy s–1 at 1 m from the Radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. 

BS EN 60976 describes measurements and test procedures to be performed by the MANUFACTURER at the design and construction stage of a medical electron accelerators but does not specify acceptance test to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests.  

BS EN 60976 specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application 

and use of medical electron accelerators and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A.  

BS EN 60976 assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted.  

Note: A statement of compliance with BS EN 60976 does not necessarily imply that these tests will be or have been applied as type tests or as individual tests. 

Who is BS EN 60976-Performance characteristics of the medical electron accelerator for? 

BS EN 60976 on performance characteristics of the medical electron accelerator is useful for: 

  • Medical electron accelerator manufacturers 
  • Medical electron accelerators test personnel 
  • Medical electron accelerator suppliers 
  • Medical laboratories  
  • Cancer hospitals  
  • Occupational health and safety departments  
  • Risk assessment authorities  
  • Quality assurance departments 

Why should you use BS EN 60976-Performance characteristics of the medical electron accelerator 

A medical linear accelerator (LINAC) is the device most used for external beam radiation treatments for patients with cancer. It delivers high-energy x-rays or electrons to the region of the patient's tumour. 

BS EN 60976 provides you with guidance on environmental conditions, general information to the user, standardized test conditions, dose monitoring systems, an indication of radiation fields, isocentres, depth absorbed dose characteristics, and format for the presentation of functional performances values, etc. 

The performance characteristics provided by BS EN 60976 assist you in improving the performance and quality of the medical electron accelerators and ensuring a reduction in the risk to human health due to the high radiation during treatments for patients.  

With obedience and compliance to BS EN 60976, you can enhance medical electron accelerators’ effectiveness and efficacy and manufacture a standardized product. 

What is changed since the last update?  

BS EN 60976:2007 supersedes EN 60976:1999 + A1:2000, which is withdrawn. BS EN 60976:2007 includes the addition of performance standards and test methods relating to the following new technologies: 

  • Dynamic beam delivery techniques, such as 
  • Moving beam radiotherapy 
  • Intensity-modulated radiation therapy (IMRT) 
  • Image-guided radiotherapy (IGRT) and  
  • Programmable wedge fields (PWF) 
  • Stereotactic radiotherapy (SRT)/Stereotactic radiosurgery (SRS) 
  • Use of electronic imaging devices