The BS EN 18778 standard has been developed by the British Standards Institute (BSI) to explain the general features and test methods of newborn monitors, which are an important part of anesthesia, respiratory and reanimation equipment.
This standard, which was later published by the International Standards Organization (ISO), was published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 18778 Respiratory equipment - Newborn monitors - Specific features.
This standard describes the requirements for the safety and basic performance of monitors used to detect life-threatening situations in sleeping or sitting children under the age of three.
This international standard applies to devices used in maintenance work in homes. It does not apply to monitors manufactured for use in healthcare facilities. In general, these monitors can be used without constant professional supervision. This standard also includes accessories such as probes and cables required to apply the monitor to the patient.
Newborn monitors are devices that monitor babies' breathing, heart rate, and movement. The main topics covered by the BS EN ISO 18778 standard are: general requirements for tests, basic safety categories, removable protective devices, environmental conditions, environmental tests, protective grounding, functional grounding and potential balancing, mechanical strength, stability in normal use, pneumatic and hydraulic power, X-radiation, microwave radiation, light radiation, infrared radiation, ultraviolet energy, electromagnetic compatibility, electrostatic charges, biocompatibility, abnormal operating and malfunction conditions and additional requirements.
Some of the baby monitors are worn on the baby's ankle and the baby's heart rate and oxygen level are monitored. If there is an abnormality in these values, it gives a warning signal.
Within the scope of breathing apparatus compatibility tests carried out by our organization EUROLAB, testing services in accordance with TS EN ISO 18778 standard are also provided.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
