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

 

Project

Reference EN 60601-2-11:1997/A1:2004
Title Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
Project Number 15468
Abstract/Scope This standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system. Applies to equipment which is intended to deliver a gamma radiation beam(s) at normal treatment distances greater than 5 cm using a sealed radioactive source(s). Establishes requirements to ensure the radiation safety and enhance the electrical and mechanical safety of gamma beam therapy equipment used in human medical practice and specifies tests for demonstrating compliance with those requirements.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2004-09-21
Current Stage code deadline 2005-06-01
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 60601-2-11:1997/A1:2004 (EQV)
ICS 11.040.60 - Therapy equipment
13.280 - Radiation protection
Keywords Medical equipment; Gamma beam therapy; Safety
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2004-09-21 2005-06-01 export to doc file  EN
5099 2004-09-01 2004-12-01  
5020 2004-04-30 2004-07-02  
4099 2003-07-18 2003-12-31  
4020 2002-09-06 2003-02-07  
3099 2002-09-03 2002-09-06  

Implementation Dates

date of Ratification (DOR) (1) 2004-09-01
date of Availability (DAV) (2) 2004-09-21
date of Announcement (DOA) (3) 2004-12-01
date of Publication (DOP) (4) 2005-06-01
date of Withdrawal (DOW) (5) 2007-09-01

Relations

Supersedes  
Superseded by FprEN 60601-2-11:2012
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.