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

 

Project

Reference EN 60601-2-28:2010
Title Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Project Number 22081
Abstract/Scope IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2010-05-07
Current Stage code deadline 2011-01-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-28:2010 (EQV)
ICS 11.040.55 - Diagnostic equipment
Keywords Medical; X-ray; Tube; Diagnosis; Safety
Note Supersedes EN 60601-2-28:1993
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2010-05-07 2011-01-01 export to doc file  EN  FR  DE
5099 2010-04-01 2010-06-01  
5060 2010-02-15 2010-03-01 export to doc file  EN
5020 2009-12-11 2010-02-12  
3090 2009-10-30 2009-11-30  
5060 2009-03-30 2009-04-13 export to doc file  EN
5020 2008-10-24 2009-03-27  
1090 2008-10-21 2008-10-24  

Implementation Dates

date of Ratification (DOR) (1) 2010-04-01
date of Availability (DAV) (2) 2010-05-07
date of Announcement (DOA) (3) 2010-07-01
date of Publication (DOP) (4) 2011-01-01
date of Withdrawal (DOW) (5) 2013-04-01

Relations

Supersedes EN 60601-2-28:1993
Superseded by  
Normative reference (6) EN 60336:2005
EN 60522:1999
EN 60601-1-3
EN 60613
IEC/TR 60788

(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.