Medical electrical equipment. Safety of radiotherapy record and verify systems

Medical electrical equipment. Safety of radiotherapy record and verify systems

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What is BS EN 62274 - Radiotherapy safety in the record and verify systems (RVS) about?

BS EN 62274 is a European standard that discusses the radiotherapy record and the verify systems.

BS EN 62274 outlines the applies to the design and manufacture and some installation aspects of a record and verify system (RVS) for use in radiotherapy in human medical practice that:

  • Provides defines, or displays treatment machine set up data, imports data either through input by the operator or directly from other devices
  • May control the ability of that equipment to operate
  • Records data of all treatment sessions
  • Are intended to be for normal use under the authority of appropriately licensed or qualified persons by operators having the required skills and training, maintained by the recommendations given in the instructions for use, and used within the environmental and electrical supply conditions specified in the technical description

BS EN 62274 applies to any RVS and establishes the requirements for features, associated documentation, and testing of the software.

Note: Requirements for the safety of hardware are not included in BS EN 62274, as these vary with the nature of the hardware.

Who is BS EN 62274 - Radiotherapy safety in RVS for?

BS EN 62274 on the radiotherapy safety in the record and verify systems (RVS) is useful for:

  • Manufacturers of medical electrical equipment
  • Record and verify system manufacturers
  • Medical laboratories and test centres
  • Regulatory authorities

Why should you use BS EN 62274 Radiotherapy safety in RVS?

Radiotherapy record and verify system (RVS) is a PEMS (programmable electrical medical system) or a subsystem that is used to help prevent erroneous set-up of a medical electron accelerator, gamma beam therapy equipment, or other radiotherapy treatment machine and to record all treatment sessions.

BS EN 62274 assists you with accompanying documents, treatment machine set-up verification, treatment recording, reporting, accuracy, abnormal operation, fault conditions, human errors in software design, changes in software versions, and human errors in use to ensure the radiotherapy safety in the record and verify systems.

BS EN 62274 provides you with the requirements to be complied with by you in the design and construction of an RVS to protect against the occurrence of such hazards.

With obedience and compliance to BS EN 62274, you can enhance the safety of RVS and manufacture a standardised product that has global acceptance in the market. In addition, minimise hazards to operators and patients.