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

 

Project

Reference EN 62083:2009
Title Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Project Number 21813
Abstract/Scope IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems: - for use in radiotherapy treatment planning in human medical practice; - that imports data either through input by the operator or directly from other devices; - that outputs data either in printed form for review or directly to other devices; and which is intended to be: a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; b) maintained in accordance with the recommendations given in the instructions for use, and c) used within the environmental and electrical supply conditions specified in the technical description. This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2009-12-11
Current Stage code deadline 2010-08-01
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62C
Reference Document IEC 62083:2009 (EQV)
ICS 11.040.60 - Therapy equipment
Keywords Medical; Safety; Radiotherapy; Planning system
Note Supersedes EN 62083:2001
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2009-12-11 2010-08-01 export to doc file  EN  FR  DE
5099 2009-11-01 2010-01-01  
5060 2009-09-08 2009-09-22 export to doc file  EN
5020 2009-07-03 2009-09-04  
3090 2008-10-31 2009-01-31  
5060 2008-09-08 2008-09-22 export to doc file  EN
5020 2008-03-21 2008-09-05  
1090 2008-03-18 2008-03-21  

Implementation Dates

date of Ratification (DOR) (1) 2009-11-01
date of Availability (DAV) (2) 2009-12-11
date of Announcement (DOA) (3) 2010-02-01
date of Publication (DOP) (4) 2010-08-01
date of Withdrawal (DOW) (5) 2012-11-01

Relations

Supersedes EN 62083:2001
Superseded by  
Normative reference (6) ICRU Report 42:1987
EN 60601-1
EN 60601-1-2:2007
corr. March 2010
IEC 60601-2-1:2009
EN 60601-2-11
IEC/TR 60788
EN 60950-1:2006
corr.
A12:2011
A11:2009
EN 61000-4-1:2007
EN 61000-4-2:2009
EN 61000-4-3:2006
EN 61000-4-4:2004
EN 61217:1996
EN 62304:2006
corr. November 2008
EN 62366

(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.