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

 

Project

Reference EN 60601-2-63:201X
Title Medical electrical equipment - Part 2-63: Particular requirements for basic safety and essential performance of dental extra-oral x-ray equipment
Project Number 23427
Abstract/Scope IEC 60601-2-63:2012 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where: - the x-ray tube assembly contains the high-voltage transformer assembly; and - the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.
Status
Approved

Status

Current Stage code 5099
Current Stage code date 2012-10-24
Current Stage code deadline 2012-11-21
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 60601-2-63:2012 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical; Equipment; Dental; Extra-oral; X-ray
Note 2012-10-09: Publication editing allocated to hamrani@cencenelec.eu
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5099 2012-10-24 2012-11-21  
5060 2012-09-10 2012-10-01 export to doc file  EN
5020 2012-07-06 2012-09-07  
5060 2011-09-05 2011-09-26 export to doc file  EN
5020 2011-03-18 2011-09-02  
1090 2011-03-15 2011-03-18  

Implementation Dates

date of Ratification (DOR) (1) 2012-10-24
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) 2013-01-24
date of Publication (DOP) (4) 2013-07-24
date of Withdrawal (DOW) (5) 2015-10-24

Relations

Supersedes  
Superseded by  
Normative reference (6) EN 60336:2005
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-3:2008
corr. March 2010
EN 60601-2-29:2008
A11:2011
EN 60601-2-54:2009
IEC/TR 60788:2004
IEC/PAS 61910-1:2007

(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.