What is BS EN IEC 60601‑2‑50 about?
BS EN IEC 60601 series covers safety and performance of medical electrical (ME) equipment. BS EN IEC 60601‑2‑50 establishes safety and performance of infant phototherapy equipment, also referred to as ME equipment.
BS EN IEC 60601‑2‑50 specifies minimum safety requirements for infant phototherapy equipment, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard is of an acceptable level when weighed against the benefit of treatment from the device.
Note: Hazards inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in BS EN IEC 60601‑2‑50,
Who is BS EN IEC 60601‑2‑50 for?
BS EN IEC 60601‑2‑50 on medical electrical equipment (infant phototherapy equipment) is applicable to manufacturers of and testing centres for medical electrical equipment (infant phototherapy equipment). Professionals who will find BS EN IEC 60601‑2‑50 useful include:
- Design engineers
- Research and development professionals
- Quality control professionals
Why should you use BS EN IEC 60601‑2‑50?
In infant phototherapy a specific type of (visible)light is applied to the care a condition (not sunlight). It is generally used to treat neonatal jaundice by lowering bilirubin levels in infants blood through a photo-oxidation process.
BS EN IEC 60601‑2‑50 establishes safety and performance requirements for protection against hazards to patients and operators as much as possible and alsospecifes tests for demonstrating compliance for infant phototherapy equipment with specific standards. BS EN Following the performance guidelines specified in BS EN IEC 60601‑2‑50 you can ensure that your infant phototherapy equipment adhere to prescribed standards.
BS EN IEC 60601‑2‑50 guidelines will help you with safety and requirements for construction and electromagnetic compatibility. This offers protection against- electrical hazards, mechanical hazards, unwanted and excessive radiation and excessive temperatures, and other hazards which will prolong the lifecycle of infant phototherapy equipment and will ensure the patient’s health and safety.
What’s changed since the last update?
BS EN IEC 60601‑2‑50:2021 supersedes IEC 60601‑2‑50:2016, which has been withdrawn. IEC 60601‑2‑50:2021 has some technical changes with respect to IEC 60601‑2‑50:2016: these include:
- Re-dating of normative references.