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

 

Project

Reference EN 62467-1
Title Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
Project Number 21537
Abstract/Scope IEC 62467-1:2009 specifies the performance and some related constructional requirements of well-type ionization chambers and associated measurement apparatus, intended for the determination of a quantity, such as air kerma strength or reference air kerma rate in photon radiation fields or absorbed dose to water at a depth, in photon and beta radiation fields used in brachytherapy, after appropriate calibration for a given type of source. IEC 62467-1:2009 covers the techniques for the quantification of the quantity appropriate for the brachytherapy source under consideration. This quantity may be air kerma strength or reference air kerma rate at 1 m, or absorbed dose to water at a depth (e.g. 2 mm or 5 mm). Measurement of these quantities may be accomplished by a variety of well-type ionization chambers or systems currently available for this purpose. This standard applies to products intended for low dose rate, high dose rate, intravascular, both photon and beta, brachytherapy measurements. It does not apply to instruments for nuclear medicine applications. The application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors. The intended use is the measurement of the output of radioactive, encapsulated sources for intracavitary (insertion into body cavities) or interstitial (insertion into body tissue) applications. The object of IEC 62467-1:2009 is a) to establish requirements for a satisfactory level of performance for well-type chamber systems, and b) to standardize the methods for the determination of compliance with this level of performance. IEC 62467-1:2009 is not concerned with the safety aspects of well-type chamber systems. The well-type chamber systems covered by this standard are not intended for use in patient environment. The electrical safety of well-type chamber systems is covered in IEC 61010-1. The operation of the electrometer measuring system is covered in IEC 60731.
Status
Approval stage

Status

Current Stage code 5098
Current Stage code date 2012-05-30
Current Stage code deadline  
Deadline date for vote  

Legal

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

Details

IEC Technical Body IEC/SC 62C
Reference Document IEC 62467-1:2009 (EQV)
ICS 11.040.50 - Radiographic equipment
11.040.60 - Therapy equipment
Keywords Medica;Dosimetry; Brachytherapy; Instrument; Ionization
Note TC advice: MDD consultant still investigating qualification as medical device cf. MDD and, hence, link to MDD and recommendation for listing is pending * Awaiting further advice from IEC/SC 62C Secretary * D141/066: VR dropped - D141/067: CLC/TC 62 & consultants to solve the negative assessment
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5098 2012-05-30    
5091 2011-01-17    
5060 2009-05-19 2009-06-02 export to doc file  EN
5020 2009-03-13 2009-05-15  
3090 2008-07-18 2008-10-31  
5060 2008-03-25 2008-04-08 export to doc file  EN
5020 2007-10-19 2008-03-21  
1090 2007-10-16 2007-10-19  

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  
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.