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

CLC/TC 62

Electrical equipment in medical practice

 

Project

Reference EN 60601-2-65:2013
Title Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Project Number 23428
Abstract/Scope IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. 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 intra-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 intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2013-01-11
Current Stage code deadline 2013-07-24
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62B
Reference Document IEC 60601-2-65:2012 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical; Equipment; Dental; Intra-oral; X-ray
Note Supersedes EN 60601-2-7:1998 (PART), EN 60601-2-32:1994 (PART)
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2013-01-11 2013-07-24 export to doc file  EN  FR  DE
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) 2013-01-11
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 EN 60601-2-7:1998
EN 60601-2-32:1994
Superseded by  
Normative reference (6) EN 60336:2005
EN 60601-1-2:2007
corr. March 2010
EN 60601-1-3:2008
corr. March 2010
IEC/TR 60788:2004
EN 62220-1:2004

(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.