MSZ EN 60601-2-28:2010

Gyógyászati villamos készülékek. 2-28. rész: A gyógyászati diagnosztikai röntgencsőegységek alapvető biztonsági és lényeges működési követelményei (IEC 60601-2-28:2010)

Medical electrical equipment. Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010)


Clause 1 of the general standard1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: – hereafter referred to as ME EQUIPMENT; – intended for medical diagnosis and imaging. 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. NOTE This International Standard is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and X-RAY TUBE HEADS. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for X-RAY TUBE ASSEMBLIES for medical diagnosis. 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 applies as modified in Clause 203. IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. NOTE 101 IEC 60601-1-2 does not apply because RISKS for the X-RAY TUBE ASSEMBLY outside the system may only be indicative of RISKS for the system due to the difference in electromagnetic environment. NOTE 102 IEC 60601-1-6 and IEC 60601-1-8 do not apply because X-RAY TUBE ASSEMBLIES are not operated as a stand-alone device. NOTE 103 X-RAY TUBE ASSEMBLIES are not in the scope of IEC 60601-1-10 and IEC 60601-1-11. Túl hosszú

Általános információk

Érvényes
angol
: 2010-09-01
: 2022-08-07

11.040.55 - Diagnosztikai készülékek

MSZT/MB 843  Gyógyászati villamos készülékek

: idt EN 60601-2-28:2010; idt IEC 60601-2-28:2010


Vásárlás

: 8 020,0 Ft
(papír , PDF-fájl-letöltés)



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MSZ EN 60601-2-28:2010

2010-09-01 - 2022-08-07