Customer Support: 131 242

i2i Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search
Home
IEC
IEC 60601-2-11:2013

IEC 60601-2-11:2013

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French

Published date

16-01-2013

Publisher

International Electrotechnical Committee

FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and
       documents
201.8 Protection against electrical HAZARDS from
       ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of
       ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
       radiation HAZARDS
201.11 Protection against excessive temperatures
       and other HAZARDS
201.12 Accuracy of controls and instruments and
       protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
       and ME SYSTEMS
Annexes
Annex B (informative) - Sequence of testing
Index of defined terms used in this particular standard

IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

DevelopmentNote
Stability date: 2017. (01/2013)
DocumentType
Standard
Pages
100
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
BS EN 60601-2-64:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
I.S. EN 60601-2-64:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
09/30182052 DC : DRAFT MAY 2009 BS EN 60601-2-8 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV
CEI EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
I.S. EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
I.S. EN 61217:2012 RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV))
I.S. EN 60601-2-17:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
VDE 0750-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
DIN EN 60601-2-64 : 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
NF EN 60601-2-64 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
10/30206860 DC : 0 BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES
BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
CSA C22.2 No. 60601.2.17 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
CSA C22.2 No. 60601-2-64 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT
CEI EN 60601-2-17 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT
BS EN 60601-2-17:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
I.S. EN 62274:2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
BS EN 62274:2005 Medical electrical equipment. Safety of radiotherapy record and verify systems
BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
CEI EN 62083 : 2011 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
UNE-EN 62083:2010 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
BS EN 61217:2012 Radiotherapy equipment. Coordinates, movements and scales
IEC 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
BS EN 62083:2009 Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
EN 60601-2-64:2015 Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
EN 60601-2-17:2015 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales

View more information
$480.56
Including GST where applicable
AUD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English - French
PDF 1 User - English - French
PDF 3 Users - English - French
PDF 5 Users - English - French
PDF 9 Users - English - French
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more