What is BS EN IEC 60601‑2‑35 about?
IEC 60601 series covers the safety and performance of medical electrical (ME) equipment. BS EN IEC 60601‑2‑35 establishes safety and performance of heating devices using blankets, pads, or mattresses in medical use, also referred to as me equipment. heating devices intended to prewarm a bed.
BS EN IEC 60601‑2‑35 applies to the safety and performance of heating devices used for medical applications.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of BS EN IEC 60601‑2‑35 are not covered by specific requirements.
Note: BS EN IEC 60601‑2‑35 does not apply to heating devices intended for physiotherapy, Infant radiant warmers, Infant incubators, Infant transport incubators, and cooling devices.
Who is BS EN IEC 60601‑2‑35 for?
BS EN IEC 60601‑2‑35 on medical electric equipment (heating devices using blankets, pads, or mattresses in medical use) is applicable to manufacturers of and testing centres for medical electrical equipment (heating devices). Professionals who will find BS EN IEC 60601‑2‑35 useful include:
- Design engineers
- Research and development professionals Quality control professionals
Why should you use IEC 60601‑2‑35?
Heating is essential in many medical devices, from anaesthesia delivery systems and respiratory therapy devices such as ventilators to blood and intravenous (IV) fluid warmers and transfusion equipment. Humidity could not be added to respiratory equipment without heaters, instruments could not be sterilised, disinfected and fluids that help stabilize body temperature after surgical procedure could not be injected into the body.
BS EN IEC 60601‑2‑35 establishes safety and performance requirements for heating devices which minimize hazards to patients, and operators for heating devices using blankets, pads, or mattresses used for heating in medical use and to specify tests for demonstrating compliance with these requirements.
Following the performance guidelines specified in BS EN IEC 60601‑2‑35 you can ensure that your heating devices adhere to prescribed standards. The testing methods listed in BS EN IEC 60601‑2‑35 help you to ensure the safety of heating devices.
BS EN IEC 60601‑2‑35 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.