SS-EN-ISO-80601-2-70 › 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)
SS-EN-ISO-80601-2-70
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2020 EDITION
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CURRENT
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This particular standard 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 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. This particular standard excludes sleep apnoea breathing therapy equipment intended for use with neonates. This particular standard is applicable to me equipment or an ME system intended for those patients who are not dependent on mechanical ventilation such as patients with central sleep apnoea. This particular standard is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
To find similar documents by classification:
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
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Designation Name
SS-EN ISO 80601-2-70:2020
Revision Level
2020 EDITION
Status
Current
Publication Date
Nov. 30, 2020
Language(s)
English
Page Count
84
International Equivalent
EN ISO 80601-2-70:2020(IDT); ISO 80601-2-70:2020(IDT)