BS EN 60601-2-45:2011+A1:2015

Clause1 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 mammographic X-ray equipment including equipment for mammographic tomosynthesis and mammographic stereotactic devices, hereafter also referred to as me equipment. NOTE1 This includes mammographic X-ray equipment using integrated digital X-ray image receptors or integrated storage phosphor subsystems. Excluded from the scope of this document are: reconstructive tomography other than mammographic tomosynthesis; ct scanners covered by IEC60601-2-44; diagnostic consoles; picture archiving and communication systems (PACS); non-integrated storage phosphor readers; hard copy cameras; films, screens and cassettes; computer aided detection (CAD); devices for performing core biopsy and other biopsy instruments; modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography); 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. NOTE2 IEC60601-2-7:1998 and IEC60601-2-32 are not part of the 3rd edition scheme for mammographic X-ray equipment and mammographic stereotactic devices. 201.1.2 Object Replacement: The object of this particular standard is to establish particular basic safety and essential performance requirements for mammographic X-ray equipment and mammographic stereotactic devices, to ensure safety, to specify methods for demonstrating compliance with those requirements and to provide guidance for risk management. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause2 of the general standard and Clause201.2 of this particular standard. IEC60601-1-2:2014 and IEC60601-1-3:2008 and IEC60601-1-3:2008/AMD1:2013 apply as modified in Clauses202 and 203, respectively. IEC60601-1-8, IEC60601-1-9, IEC60601-1-10, IEC60601-1-11 and IEC60601-1-12 do not apply2). All other published collateral standards in the IEC60601-1-X series apply as published. 201.1.4 Particular standards Replacement: In the IEC60601 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 or a collateral standard. For brevity, IEC60601-1 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 Clause1 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 Clause4 of the IEC60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause4 of the IEC60601-1-3 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 3.139, 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 IEC60601-1-2, 203 for IEC60601-1-3, 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.