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

 

Project

Reference EN 60976:2007
Title Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
Project Number 20578
Abstract/Scope Applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This standard applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests. The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods. This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients. Except where otherwise stated this standard assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted. This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: - dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields; - stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS); - use of electronic imaging devices. This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2007-12-07
Current Stage code deadline 2008-08-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/SC 62C
Reference Document IEC 60976:2007 (EQV)
ICS 11.040.50 - Radiographic equipment
13.280 - Radiation protection
Keywords Medical; Electron accelerator; Functional performance
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2007-12-07 2008-08-01 export to doc file  EN  FR  DE
5099 2007-11-01 2008-01-01  
5060 2007-09-11 2007-09-25 export to doc file  EN
5020 2007-07-06 2007-09-07  
4099 2006-08-11 2006-12-31  
5060 2006-07-10 2006-07-24 export to doc file  EN
5020 2006-02-03 2006-07-07  
1090 2006-01-31 2006-02-03  

Implementation Dates

date of Ratification (DOR) (1) 2007-11-01
date of Availability (DAV) (2) 2007-12-07
date of Announcement (DOA) (3) 2008-02-01
date of Publication (DOP) (4) 2008-08-01
date of Withdrawal (DOW) (5) 2010-11-01

Relations

Supersedes EN 60976:1999
EN 60976:1999/A1:2000
Superseded by  
Normative reference (6) EN 60580:2000
EN 60601-1:2006
corr. March 2010
corr.
A11:2011
EN 60601-2-1:1998
A1:2002
IEC/TR 60788:2004
IEC/TR 60977:1989
EN 61217:1996
IEC 61223-1:1993

(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.