ÖNORM EN ISO 80601-2-70:2021 05 15
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Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020)
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05-15-2021
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by: This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient.
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