Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French

Published date

09-04-2014

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
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 for
me equipment
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
201.101 Reference data for X-IGRT
201.102 X-IGRT IMAGING
201.103 IGRT analysis and correction
203 RADIATION protection in diagnostic X-RAY EQUIPMENT
206 Usability
Annex B (informative) - Sequence of testing
Annex I (informative) - ME SYSTEMS aspects
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Measuring CTDI[free air]
Bibliography
Index of defined terms used in this standard

IEC 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

DevelopmentNote	Stability date: 2018. (09/2014)
DocumentType	Standard
Pages	130
PublisherName	International Electrotechnical Committee
Status	Current

Standards	Relationship
NEN EN IEC 60601-2-68 : 2015	Identical
BS EN 60601-2-68:2015	Identical
NBN EN 60601-2-68 : 2015	Identical
EN 60601-2-68:2015	Identical
OVE EN 60601-2-68:2020 05 01	Identical
IS 13450 : Part 2 : Sec 68:2020	Identical
JIS T 60601-2-68:2019	Identical
PN EN 60601-2-68 : 2015	Identical
NF EN 60601-2-68 : 2015	Identical
DIN EN 60601-2-68:2020	Identical
VDE 0750-2-68:2020	Identical
SN EN 60601-2-68:2015	Identical
UNE-EN 60601-2-68:2015	Identical
ABNT NBR IEC 60601-2-68:2023	Identical

IEC 60336:2005	Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
IEC 60364-7-710:2002	Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
IEC 60731:2011+AMD1:2016 CSV	Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60522:1999	Determination of the permanent filtration of X-ray tube assemblies
IEC TR 60788:2004	Medical electrical equipment - Glossary of defined terms
IEC 60601-1-6:2010+AMD1:2013 CSV	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60976:2007	Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
IEC 61262-7:1995	Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function
IEC 62274:2005	Medical electrical equipment - Safety of radiotherapy record and verify systems
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
IEC TR 60977:2008	Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics
IEC 60601-2-4:2010	Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
IEC 62563-1:2009+AMD1:2016 CSV	Medical electrical equipment - Medical image display systems - Part1: Evaluation methods
IEC 62220-1:2003	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
IEC 61223-3-5:2004	Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
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 60601-2-1:2009+AMD1:2014 CSV	Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
IEC 62396-1:2016	Process management for avionics - Atmospheric radiation effects - Part 1: Accommodation of atmospheric radiation effects via single event effects within avionics electronic equipment
ISO 9334:2007	Optics and photonics Optical transfer function Definitions and mathematical relationships
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV	Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

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IEC 60601-2-68:2014

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