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

 

Project

Reference EN 60601-2-29:1995
Title Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators
Project Number 4920
Abstract/Scope This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Standard applies to RADIOTHERAPY SIMULATORS which use diagnostic X-RAY EQUIPMENT to simulate physically a therapeutic RADIATION BEAM. So that the TREATMENT VOLUME to be irradiated during RADIOTHERAPY can be localized, and the position and size of the therapeutic RADIATION FIELD can be confirmed. This Standard applies to RADIOTHERAPY SIMULATORS using HIGH-VOLTAGE GENERATORS complying with EN 60601-2-7. This Standard applies to RADIOTHERAPY SIMULATORS intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations. This Standard applies to RADIOTHERAPY SIMULATORS comprising the following parts: a} A system for producing a RADIATION BEAM not exceeding 400 kV which simulates the geometry of the RADIOTHERAPY RADIATION BEAM. b) A system for producing images of the transmitted X-RAY BEAM, for example either by RADIOGRAPHY or by RADIOSCOPY. C) An assembly to control the size of the RADIATION BEAM and to DELINEATE the intended treatment area. d) A mechanical structure which physically simulates the geometry and motions of the RADIOTHERAPY EQUIPMENT and supports the imaging system. e) A PATIENT SUPPORT system.
Status
Withdrawn

Status

Current Stage code 6060
Current Stage code date 1995-11-30
Current Stage code deadline 1996-07-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s) M/023
Order Voucher BC/CLC/93-01

Details

IEC Technical Body IEC/SC 62C
Reference Document IEC 60601-2-29:1993 (EQV)
ICS 11.040.60 - Therapy equipment
Keywords Medical equipment; Radiotherapy; Simulator; Safety
Note Superseded by EN 60601-2-29:1999
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1995-11-30 1996-07-01 export to doc file  EN
5099 1995-05-15 1995-06-15  
5061 1995-04-14 1995-05-15  
5020 1994-12-07 1995-03-15  
1599 1994-10-04 1995-04-04  
1560 1994-08-22 1994-11-22  
1520 1994-03-02 1994-06-15  
1099 1994-02-28 1994-03-31  
1099 1993-07-13    
1000 1993-06-16    

Implementation Dates

date of Ratification (DOR) (1) 1995-05-15
date of Availability (DAV) (2) 1995-11-30
date of Announcement (DOA) (3) 1996-01-01
date of Publication (DOP) (4) 1996-07-01
date of Withdrawal (DOW) (5) 1996-07-01

Relations

Supersedes  
Superseded by EN 60601-2-29:1999
Normative reference (6) EN 60601-1-3:1994
IEC 60601-2-1:1981
HD 395.2.7 S1:1989
HD 501 S1:1988

(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.