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

 

Project

Reference EN 60601-2-17:2004
Title Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
Project Number 15469
Abstract/Scope The use of afterloading equipment for brachytherapy purposes may expose patients to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radioactive source(s) adequately within the storage container(s) and/or if there are inadequacies in the design of the treatment room. This Particular Standard establishes requirements to be complied with by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the equipment.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2004-04-06
Current Stage code deadline 2004-12-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/432
Order Voucher  

Details

IEC Technical Body IEC/SC 62C
Reference Document IEC 60601-2-17:2004 (EQV)
ICS 11.040.60 - Therapy equipment
19.100 - Non-destructive testing
Keywords Medical equipment; Brachytherapy; Afterloading; Automatically-controlled; Safety
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2004-04-06 2004-12-01 export to doc file  EN  FR  DE
5099 2004-03-01 2004-05-01  
5061 2004-01-26 2004-03-01  
5020 2003-10-31 2004-01-09  
4099 2003-02-21 2003-12-31  
4020 2002-09-06 2003-02-07  
3099 2002-09-03 2002-09-06  

Implementation Dates

date of Ratification (DOR) (1) 2004-03-01
date of Availability (DAV) (2) 2004-04-06
date of Announcement (DOA) (3) 2004-06-01
date of Publication (DOP) (4) 2004-12-01
date of Withdrawal (DOW) (5) 2007-03-01

Relations

Supersedes EN 60601-2-17:1996
EN 60601-2-17:1996/A1:1996
Superseded by FprEN 60601-2-17:2013
Normative reference (6) EN 60601-1:1990
corr. July 1994
A1:1993
A2:1995
A11:1993
A12:1993
A13:1996
EN 60601-1-1:2001
EN 60601-1-2:2001
EN 60601-1-4:1996
A1:1999
HD 501 S1:1988
EN 61217:1996
A1:2001
EN 62083:2001

(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.