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



Reference EN 60601-2-45:2001
Title Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
Project Number 13404
Abstract/Scope Formulates appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment. Establishes particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. The safety requirements for the X-ray generator and its sub-assemblies form an integral part of this standard. Cancels and replaces the first edition published in 1998 and constitutes a technical revision.


Current Stage code 6060
Current Stage code date 2001-07-30
Current Stage code deadline 2002-04-01
Deadline date for vote  


Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  


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


Categories - Aspects
Product Life Cycle


Deadline Date
6060 2001-07-30 2002-04-01 export to doc file  EN
5099 2001-07-01 2001-11-01  
5061 2001-05-29 2001-09-01  
5020 2001-02-09 2001-04-13  
4099 2000-04-14 2000-08-31  
4020 1999-08-27 2000-01-31  
3099 1999-08-23 1999-08-27  

Implementation Dates

date of Ratification (DOR) (1) 2001-07-01
date of Availability (DAV) (2) 2001-07-30
date of Announcement (DOA) (3) 2001-10-01
date of Publication (DOP) (4) 2002-04-01
date of Withdrawal (DOW) (5) 2004-07-01


Supersedes EN 60601-2-45:1998
Superseded by EN 60601-2-45:2011
Normative reference (6)  

(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.