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MSZ EN ISO 80601-2-72:2016

Dokumentumazonosító

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Cím

Gyógyászati villamos készülékek. 2-72. rész: Lélegeztetőre kapcsolt páciensek otthoni egészségügyi ellátására szolgáló lélegeztetőjének alapvető biztonsági és lényeges teljesítőképességi követelményei (ISO 80601-2-72:2015)

Angol cím

Medical electrical equipment. Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator- dependent patients (ISO 80601-2-72:2015)

Alkalmazási terület

IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in EQUIPMENT: combination with its ACCESSORIES, hereafter referred to as MECARE ENVIRONMENT; — intended for use in the HOME HEALTH — intended for use by a LAY OPERATOR; ndr use withependepport. — inteed fo PATIENTS who are dnt on mechanical ventilation for their life suENTILATORS can also be used foependent ort. NOTE 1 Such Vr PATIENTS who are not dn ventilatory suppo HOME HEALT NOTE 2 In theHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable. NOTE 3 Such VENTILATORS can also be used in non-critical care applications of professional health care facilities. This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those S ca ACCESSORIEn affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, and DISTRIBUTED ALARM SYSTEM. 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 part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in 01 IEC 606-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601–1:2005+AMD1:2012, 4.2. This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, high-frequency jet ventilators (HFJVs), and high-frequency oscillatory ventilators (HFOVs)[35]. This part of ISO 80601 does not specify the requirements for cuirass and “iron-lung” VENTILATORS. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications, which are given in ISO 80601-2-12. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in ISO 80601-2-13. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for nc emergey and transport which are given in ISO 10651-3. NOTE 5 In the future, ISO 10651-3 is expected to be harmonized with IEC 60601-1:2005, at which time it will be replaced by ISO 80601-2-xx. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support equipment (intended only to augment the ventilation of spontaneously g breathinPATIENTS), which are given in ISO 10651-6. NOTE 6 In the future, ISO 10651-6 is expected to be harmonized with IEC 60601-1:2005 and IEC 60601-1-11:2015, at which time it will be replaced by ISO 80601-2-xx. This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601-2-70.[16] This part of ISO 80601 is a particular International Standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-02-01

A visszavonás napja

2023-12-01

Forrás

idt EN ISO 80601-2-72:2015; idt ISO 80601-2-72:2015

Előd

MSZ EN ISO 10651-2:2009

Utód

MSZ EN ISO 80601-2-72:2023

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

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