Hivatkozási szám

MSZ EN IEC 80601-2-26:2020

Dokumentumazonosító

175994

Cím

Gyógyászati villamos készülékek. 2-26. rész: Elektroenkefalográfok alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 80601-2-26:2019)

Angol cím

Medical electrical equipment. Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs (IEC 80601-2-26:2019)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. 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. NOTE See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.204. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2:2014 and IEC 60601-1-6:2013 apply as modified in Clause 202 and 206, respectively. IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. Túl hosszú scope

ICS

11.040.01 Orvostechnikai berendezések általában

11.040.55 Diagnosztikai készülékek

11.040.99 Egyéb orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-11-01

Forrás

idt IEC 80601-2-26:2019; idt EN IEC 80601-2-26:2020/AC:2021; idt EN IEC 80601-2-26:2020; idt IEC 80601-2-26:2019/COR1:2021-10

Előd

MSZ EN 60601-2-26:2015

Utód

Módosítás

SZK-közlemények

2021/12: Helyesbítés

Kapcsolódó európai jogszabály

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

A szabvány

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