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I.S. EN 60601-2-68:2015

Current
Current

The latest, up-to-date edition.

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

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 CTDIfree air
Bibliography
Index of defined terms used in this standard
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZ (informative) - Coverage of Essential
         Requirements of EU Directives

Pertains to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE).

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
144
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
EN 60601-2-68:2015 Identical

IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
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
EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
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
EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
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 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
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
EN 61262-7:1995 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function
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
EN 60731:2012 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
IEC 61217:2011 Radiotherapy equipment - Coordinates, movements and scales
EN 62083:2009 MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
EN 62563-1:2010/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL IMAGE DISPLAY SYSTEMS - PART 1: EVALUATION METHODS (IEC 62563-1:2009/A1:2016)
EN 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 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
EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
ISO 9334:2007 Optics and photonics Optical transfer function Definitions and mathematical relationships
EN 60601-2-44:2009/A2:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016)
EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
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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