What is BS EN IEC 60601‑2‑1 about?
BS EN IEC 60601 series covers the safety and performance of medical electrical (ME) equipment. BS EN IEC 60601‑2‑1 discusses the safety and performance of electron accelerators when within the range of 1 MeV to 50 MeV.
BS EN IEC 60601‑2‑1 establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy.
BS EN IEC 60601‑2‑1 applies to the safety and performance of electron accelerators, also referred to as medical electrical (ME) equipment, in the range 1 MeV to 50 MeV, used for the treatment of patients.
Note: While electron accelerators used for the treatment of patients are always ME equipment, there are times in BS EN IEC 60601‑2‑1 where they are referred to as external beam equipment (EBE). Usage of EBE does not remove the requirements placed on the ME equipment but is meant to clarify that the ME equipment being discussed is the EBE and not some other ME equipment that may be part of the system configuration.
Who is BS EN IEC 60601‑2‑1 for?
BS EN IEC 60601‑2‑1 on medical electrical equipment (electron accelerators) is applicable to:
- Manufacturers of and testing centres for medical electrical equipment (electron accelerators)
- Design engineers/ electrical engineer
- Research and development professionals
- Quality control professionals
Why should you use BS EN IEC 60601‑2‑1?
The use of electron accelerators for radiotherapy purposes may expose patients to danger if the ME equipment fails to deliver the required dose distribution to the patient, or if the ME equipment design fails to meet the requirements of safety and performance. Following the performance guidelines specified in BS EN IEC 60601‑2‑1 you can ensure that your electron accelerators for radiotherapy adhere to prescribed standards.
Following BS EN IEC 60601‑2‑1 guidelines help you with guidance on type tests and site tests, applicable to the manufacture and some installation aspects of electron accelerators. Thus, enabling you to increase the precision, accuracy, and volumetric targeting of the treatment delivery.
BS EN IEC 60601‑2‑1 helps ensure protection against electrical hazards from ME equipment, unwanted and excessive radiation hazards, and excessive temperatures and other hazards.
BS EN IEC 60601‑2‑1 guidelines will also help you with requirements on construction, marking, documents, safety measures, and accessories for ME equipment. Also, it provides you guidance on electromagnetic compatibility and usability which prolongs the life of ME equipment and ensures the safety of users.
What’s changed since the last update?
BS EN IEC 60601‑2‑1:2021 supersedes IEC 60601‑2‑1:2009 and amendments 1-2014. BS EN IEC 60601‑2‑1:2021 has some technical changes with respect to IEC 60601‑2‑1:2009, these include:
- Alignment with the new relevant collateral standards
- Addition of computer interface and control
- Addition of new technologies in radiotherapy, including beam gating, and adaptive radiotherapy