What is BS EN IEC 60601‑2‑19 about?
IEC 60601 series covers the safety and performance of medical electrical (ME) equipment. BS EN IEC 60601‑2‑19 discusses the safety and performance of infant incubators, also referred to as ME equipment.
BS EN IEC 60601‑2‑19 specifies safety requirements for infant incubators, 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: BS EN IEC 60601‑2‑19 does not apply to infant transport incubators, infant radiant warmers, devices supplying heat via blankets, pads or mattresses in medical use, and infant phototherapy equipment.
Who is BS EN IEC 60601‑2‑19 for?
BS EN IEC 60601‑2‑19 on medical electric equipment (infant incubators) is applicable to:
- Manufacturers of and testing centres for medical electrical equipment (surgical luminaries and luminaries for diagnosis)
- Design engineers/ electrical engineers
- Research and development professionals Quality control professionals
Why should you use BS EN IEC 60601‑2‑19?
Infant incubators help babies from infection, allergies, germs, and harmful risks of high light and sound therefore requirements for the safety and performance of infant incubators are essential. Following the performance guidelines of BS EN IEC 60601‑2‑19 you can ensure that your infant incubators prescribed standards. The testing methods listed in BS EN IEC 60601‑2‑19 help you to ensure the safety of the infant incubators.
The object of BS EN IEC 60601‑2‑19is to establish particular basic safety and essential performance requirements for INFANT INCUBATORS, which minimize hazards to patient and operator, and to specify tests by which compliance with the requirements can be verified.
BS EN IEC 60601‑2‑19 provides you w guidance for achieving compliance with the requirements for construction and electromagnetic compatibility of infant incubators. a
BS EN IEC 60601‑2‑19 helps ensure protection against electrical hazards, mechanical hazards, unwanted and excessive radiation and excessive temperatures, and other hazards which will prolong the lifecycle of infant incubators and will ensure the patient’s health and safety.