Respiratory equipment. Infant monitors. Particular requirements
Respiratory equipment. Infant monitors. Particular requirements
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BS EN ISO 18778:2009 Respiratory equipment. Infant monitors. Particular requirements BS EN ISO 18778 specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. BS EN ISO 18778 applies to devices used in home care applications. These monitors are generally used without continual professional supervision. BS EN ISO 18778 also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient. BS EN ISO 18778 does not apply to monitors intended for use in health care facilities/institutions. The requirements of BS EN ISO 18778, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements. Contents of BS EN ISO 18778:
Foreword Introduction Scope Normative references Terms and definitions General requirements and general requirements for tests ClassificationIdentification, marking and documents Power input Basic safety categories Removable protective means Environmental conditions Not used Not used General Requirements related to classification Limitation of voltage and/or energy Enclosures and protective covers Separation Protective earthing, functional earthing and potential equalization Continuous leakage currents and patient auxiliary currents Dielectric strength Mechanical strength Moving parts Surfaces, corners and edges Stability in normal use Expelled parts Vibration and noise Pneumatic and hydraulic power Suspended masses
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