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

 

Project

Reference FprEN 60601-2-11:2012
Title Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
Project Number 22963
Abstract/Scope IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2013-02-21
Current Stage code deadline  
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 60601-2-11:2013 (EQV)
ICS 11.040.60 - Therapy equipment
Keywords Medical; Gamma; Beam; Therapy
Note Negative assessment from Consultant * Will supersede EN 60601-2-11:1997 + A1:2004
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2013-02-21    
5060 2012-12-17 2013-01-07 export to doc file  EN
5020 2012-10-12 2012-12-14  
3090 2011-07-15 2011-10-15  
5060 2010-10-11 2010-10-25 export to doc file  EN
5020 2010-05-07 2010-10-08  
1090 2010-05-04 2010-05-07  

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) dor + 3 months
date of Publication (DOP) (4) dor + 9 months
date of Withdrawal (DOW) (5) dor + 36 months

Relations

Supersedes EN 60601-2-11:1997
EN 60601-2-11:1997/A1:2004
Superseded by  
Normative reference (6)  

(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.