Hivatkozási szám

MSZ EN ISO 80601-2-70:2021

Dokumentumazonosító

176771

Cím

Gyógyászati villamos készülékek. 2-70. rész: Az alvási apnoe légzésterápiás készülékeinek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-70:2020)

Angol cím

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)

Alkalmazási terület

201.1 * Scope, object and related standards IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 201.1.1 Scope 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. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document 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. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. Túl hosszú scope

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2021-04-01

Forrás

idt ISO 80601-2-70:2020; idt EN ISO 80601-2-70:2020

Előd

MSZ EN ISO 17510-1:2009

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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