Back

EVS-EN 60601-2-11:2001

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

General information

Withdrawn from 08.06.2015
Base Documents
IEC 60601-2-11:1997; EN 60601-2-11:1997
ICS Groups
11.040.60 Therapy equipment 13.280 Radiation protection
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
08.06.2015
Main
EVS-EN 60601-2-11:2015
10.12.2004
Amendment
EVS-EN 60601-2-11:2001/A1:2004
01.07.2001
Main
EVS-EN 60601-2-11:2001
This Particular 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 (PES).

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 598 KB)

Related products

Main

EVS-EN 60601-2-11:2015

Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
Newest version Valid from 08.06.2015
Amendment

EVS-EN 60601-2-11:2001/A1:2004

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
Withdrawn from 08.06.2015
Main

EVS-EN 60601-2-10:2015

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Newest version Valid from 08.06.2015
Amendment

EVS-EN 60601-2-10:2015/A1:2016

Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Newest version Valid from 03.01.2017

Customers who bought this item also bought

Main

EVS-EN ISO 80601-2-61:2011

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
Withdrawn from 15.02.2019
Main

EVS-EN 60601-2-27:2014

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
Newest version Valid from 03.09.2014
Main

EVS-EN 60601-2-34:2014

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Newest version Valid from 04.08.2014
Main + corrigendum

EVS-EN 60601-1:2006

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
Valid from 08.12.2006

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English