BS EN ISO 80601-2-70:2020 PDF

What is ISO 80601 ‑ 2 ‑ 70 about?

ISO 80601 discusses medical electrical equipment. ISO 80601-2-70 outlines the basic safety and essential performance of sleep apnoea breathing therapy equipment hereafter referred to as medical electrical (ME) equipment. Sleep apnoea breathing therapy equipment is 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. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. ISO 80601 ‑ 2 ‑ 70 applies to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. Note 1: ISO 80601 ‑ 2 ‑ 70 excludes sleep apnoea breathing therapy equipment intended for use with neonates. Note 2: ISO 80601 ‑ 2 ‑