Hivatkozási szám

MSZ EN ISO 80601-2-67:2021

Dokumentumazonosító

176769

Cím

Gyógyászati villamos készülékek. 2-67. rész: Az oxigéntároló berendezések alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-67:2020)

Angol cím

Medical electrical equipment. Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO 80601-2-67:2020)

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+AMD1:2012, 1.1 is replaced by: This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator^[2]ˇ, an oxygen concentrator^[7]ˇ or liquid oxygen equipment^[4]ˇ. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). 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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. 201.1.2 Object IEC 60601-1:2005, 1.2 is replaced by: The object of this document is to establish particular basic safety and essential performance requirements for conserving equipment [as defined in 201.3.201] and its accessories. 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 80601-2-67:2020; idt EN ISO 80601-2-67:2020

Előd

MSZ EN ISO 18779:2005

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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