Hivatkozási szám

MSZ EN 60601-2-40:2020

Dokumentumazonosító

173759

Cím

Gyógyászati villamos készülékek. 2-40. rész: Elektromiográfok és kiváltottválasz-készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-40:2016)

Angol cím

Medical electrical equipment. Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (IEC 60601-2-40:2016)

Alkalmazási terület

Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this particular standard. 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. The following ME EQUIPMENT is excluded: ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.) 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT [as defined in 201.3.201 and 201.3.202.] 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 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”, where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.) The changes to the text of the general standard are specified by the use of the following words: "Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. "Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

ICS

11.040.20 Vérátömlesztő, infúziós és injekciós berendezések, eszközök

11.040.55 Diagnosztikai készülékek

11.040.99 Egyéb orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-01-01

Forrás

idt IEC 60601-2-40:2016; idt EN 60601-2-40:2019

Előd

MSZ EN 60601-2-40:1999

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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