BS EN 60601-2-68:2015
Current
The latest, up-to-date edition.
Medical electrical equipment 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
Hardcopy , PDF
English
30-06-2015
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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 equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).
| Committee |
CH/62/3
|
| DevelopmentNote |
Supersedes 12/30246621 DC. (06/2015)
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| EN 60601-2-68:2015 | Identical |
| IEC 60601-2-68:2014 | 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 |
| EN 60522:1999 | Determination of the permanent filtration of X-ray tube assemblies |
| 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 |
| EN 60336:2005 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
| 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 |
| HD 60364-7-710:2012/AC:2013 | LOW-VOLTAGE ELECTRICAL INSTALLATIONS - PART 7-710: REQUIREMENTS FOR SPECIAL INSTALLATIONS OR LOCATIONS - MEDICAL LOCATIONS |
| 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 62220-1:2004 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency |
| 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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