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

 

Project

Reference FprEN 60601-2-17:2013
Title Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
Project Number 22894
Abstract/Scope IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. This third edition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.
Status
Approval stage

Status

Current Stage code 5091
Current Stage code date 2014-02-03
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 60601-2-17:2013 (EQV)
ICS 11.040.60 - Therapy equipment
19.100 - Non-destructive testing
Keywords Medical equipment; Brachytherapy; Afterloading; Automatically-controlled; Safety
Note Will supersede EN 60601-2-17:2004
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5091 2014-02-03    
5060 2013-11-12 2013-12-03 export to doc file  EN
5020 2013-09-06 2013-11-08  
3090 2011-07-15 2011-10-15  
5060 2010-09-06 2010-09-20 export to doc file  EN
5020 2010-03-26 2010-09-03  
1090 2010-03-23 2010-03-26  

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 60601-2-17:2004
Superseded by  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.