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



Reference EN 60601-2-11:1997
Title Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
Project Number 7099
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.


Current Stage code 6060
Current Stage code date 1997-09-30
Current Stage code deadline 1998-05-01
Deadline date for vote  


Directive(s) MDD (93/42/EEC)
Mandate(s) M/023; M/432
Order Voucher BC/CLC/93-01


IEC Technical Body IEC/SC 62C
Reference Document IEC 60601-2-11:1997 (EQV)
ICS 11.040.50 - Radiographic equipment
Keywords Medical equipment; Gamma beam therapy; Safety
Note EN following parallel vote * Supersedes HD 395.2.11 S2
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
6060 1997-09-30 1998-05-01 export to doc file  EN
6020 1997-08-01 1997-11-01  
5099 1997-07-01 1997-08-01  
5062 1997-04-29 1997-07-01  
5020 1997-01-24 1997-03-31  
1090 1997-01-20 1997-01-24  

Implementation Dates

date of Ratification (DOR) (1) 1997-07-01
date of Availability (DAV) (2) 1997-09-30
date of Announcement (DOA) (3) 1997-11-01
date of Publication (DOP) (4) 1998-05-01
date of Withdrawal (DOW) (5) 1998-05-01


Supersedes HD 395.2.11 S2:1990
Superseded by FprEN 60601-2-11:2012
Normative reference (6) HD 501 S1:1988
EN 61217:1996

(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.