Hivatkozási szám

MSZ EN IEC 80601-2-60:2020

Dokumentumazonosító

175995

Cím

Gyógyászati villamos készülékek. 2-60. rész: Fogászati berendezések alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 80601-2-60:2019)

Angol cím

Medical electrical equipment. Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment (IEC 80601-2-60:2019)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope Replacement: This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. 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. 201.1.2 Object Replacement: The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for DENTAL EQUIPMENT (as defined in 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 60601-1-3 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 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. Túl hosszú scope

ICS

11.040.01 Orvostechnikai berendezések általában

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-11-01

Forrás

idt EN IEC 80601-2-60:2020; idt IEC 80601-2-60:2019

Előd

MSZ EN 80601-2-60:2015

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

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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