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


Electrical equipment in medical practice



Reference EN 62083:2001
Title Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Project Number 7619
Abstract/Scope Applies to the design, manufacture and some installation aspects of an RTPS - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or direct from other devices; - that outputs data either in printed form for review or direct to other devices; - and which is intended to be . for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; . maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and . used within the environmental and electrical supply conditions SPECIFIED in the technical descriptions. An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software.


Current Stage code 6060
Current Stage code date 2001-02-12
Current Stage code deadline 2001-09-01
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 62C
Reference Document IEC 62083:2000 (EQV)
ICS 11.040.60 - Therapy equipment
Keywords Medical; Radiotherapy; Treatment; Planning; Safety
Note EN following parallel voten * Superseded by EN 62083:2009
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 2001-02-12 2001-09-01 export to doc file  EN
5099 2000-12-01 2001-04-01  
5061 2000-10-26 2000-12-01  
5020 2000-08-04 2000-10-16  
4099 2000-07-31 2000-08-04  
4020 1998-10-30 1999-03-31  
3099 1998-10-26 1998-10-30  
1090 1998-10-26 1998-10-30  
1000 1996-03-11 1996-09-11  

Implementation Dates

date of Ratification (DOR) (1) 2000-12-01
date of Availability (DAV) (2) 2001-02-12
date of Announcement (DOA) (3) 2001-03-01
date of Publication (DOP) (4) 2001-09-01
date of Withdrawal (DOW) (5) 2003-12-01


Superseded by EN 62083:2009
Normative reference (6) ICRU Report 42:1987
EN 60601-1:1990
corr. July 1994
EN 60601-1-2:1993
corr. December 1997
EN 60601-1-4:1996
HD 501 S1:1988
EN 60950:2000
corr. February 2002
EN 61000-4-1:2000
EN 61000-4-2:1995
EN 61000-4-3:1996
EN 61000-4-4:1995
EN 61217:1996

(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.