What is BS EN IEC 60601‑2‑21 about?
IEC 60601 series covers safety and performance of medical electrical (ME) equipment. BS EN IEC 60601‑2‑21 focuses on safety and performance of infant radiant warmers also referred to as ME equipment.
BS EN IEC 60601‑2‑21 specifies the safety requirements for infant radiant warmers, 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 has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
Note: BS EN IEC 60601‑2‑21 does not apply to devices supplying heat via blankets, pads or mattresses in medical use, infant incubators, infant transport incubators, and infant phototherapy equipment.
Who is BS EN IEC 60601‑2‑21 for?
BS EN IEC 60601‑2‑21 on medical electrical equipment (infant radiant warmers) is applicable to manufacturers of and testing centres for medical electrical equipment (infant radiant warmers). Professionals who will find BS EN IEC 60601‑2‑21 useful include:
- Design engineers
- Research and development professionals Quality control professionals
Why should you use BS EN IEC 60601‑2‑21?
Baby-controlled radiant warmer is a mode of operation in which the power output varies automatically to maintain the temperature as measured by a skin temperature sensor according to the control temperature set by the operator for which safety and performance has been established in BS EN IEC 60601‑2‑21.
Following the performance guidelines specified in BS EN IEC 60601‑2‑21, you can ensure that your Infant radiant warmers adhere to prescribed standards. The testing methods listed in BS EN IEC 60601‑2‑21 help you to ensure the safety of Infant radiant warmers.
BS EN IEC 60601‑2‑21 provides you with requirements for construction and electromagnetic compatibility. Thus, ensuring protection against electrical hazards, mechanical hazards, unwanted and excessive radiation and excessive temperatures, and other hazards which will prolong the lifecycle of infant radiant warmers and will ensure the patient’s health and safety.