Hivatkozási szám

MSZ EN IEC 60601-2-28:2020

Dokumentumazonosító

674874

Cím

Gyógyászati villamos készülékek. 2-28. rész: A gyógyászati diagnosztikai röntgencsőegységek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-28:2017)

Angol cím

Medical electrical equipment. Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2017)

Alkalmazási terület

201.1.1 Scope Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT, this is interpreted as X-RAY TUBE ASSEMBLIES in 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. NOTE This document is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and XRAY 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 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 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, IEC 60601-1-11 and IEC 60601-1-12 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, IEC 60601-1-11 and IEC 60601-1-12. 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. 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 document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x 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 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 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 document 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 document” 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

11.040.55 Diagnosztikai készülékek

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-05-01

Forrás

idt EN IEC 60601-2-28:2019; idt IEC 60601-2-28:2017

Előd

MSZ EN 60601-2-28:2010

Utód

Módosítás

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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