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



Reference EN 60601-2-28:1993
Title Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
Project Number 4224
Abstract/Scope Specifies the safety requirements for X-ray tube assemblies for medical diagnoses and components thereof, specified for use in medical X-ray equipment including equipment for computed tomography, that incorporates a specified high-voltage generator complying with HD 395.2.7 or HD 395.2.15.


Current Stage code 6060
Current Stage code date 1993-05-28
Current Stage code deadline 1994-03-01
Deadline date for vote  


Directive(s) MDD (93/42/EEC)
Mandate(s) M/023; M/432
Order Voucher BC/CLC/93-01


IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-28:1993 (EQV)
Keywords Medical equipment; X-ray source assemblies; X-ray tube assemblies; Safety
Note EN following parallel vote * Superseded by EN 60601-2-54:2009 * Superseded by EN 60601-2-28:2010
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 1993-05-28 1994-03-01 export to doc file  EN
5099 1993-03-09 1993-04-09  
5020 1992-07-03 1992-11-15  

Implementation Dates

date of Ratification (DOR) (1) 1993-03-09
date of Availability (DAV) (2) 1993-05-28
date of Announcement (DOA) (3) 1993-06-01
date of Publication (DOP) (4) 1994-03-01
date of Withdrawal (DOW) (5) 1994-03-01


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of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn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