International Standards and Conformity Assessment for all electrical, electronic and related technologies



Reference EN 60601-2-45:2011
Title Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Project Number 22703
Abstract/Scope IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.


Current Stage code 6060
Current Stage code date 2011-03-18
Current Stage code deadline  
Deadline date for vote  


Directive(s) MDD pending (93/42/EEC)
Mandate(s) M/295
Order Voucher  


IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-45:2011 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical; Safety; Mammography; X-ray; Stereotactic
Note Supersedes EN 60601-2-45:2001
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 2011-03-18   export to doc file  EN  FR  DE
5099 2011-03-17 2011-04-14  
5060 2011-01-18 2011-02-08 export to doc file  EN
5020 2010-11-12 2011-01-14  
5060 2010-04-06 2010-04-20 export to doc file  EN
3090 2010-01-10 2010-10-31  
5020 2009-10-30 2010-04-02  
1090 2009-10-27 2009-10-30  

Implementation Dates

date of Ratification (DOR) (1) 2011-03-17
date of Availability (DAV) (2) 2011-03-18
date of Announcement (DOA) (3) 2011-06-17
date of Publication (DOP) (4) 2011-12-17
date of Withdrawal (DOW) (5) 2014-03-17


Supersedes EN 60601-2-45:2001
Superseded by  
Normative reference (6) ISO 9236-3:1999
EN 60336:2005
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-3:2008
corr. March 2010
EN 60613:2010
IEC/TR 60788:2004
EN 61223-3-2:2008
EN 62220-1-2:2007

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved

(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat

(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level

(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement

(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn

(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.