WG 1 - TC 62/SC 62C/WG 1

IEC 60601-2-1:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS.
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
• maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and
• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE;
and
– intended to be
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new relevant collateral standards;
b) addition of computer interface and control;
c) addition of new technologies in RADIOTHERAPY, including
• BEAM GATING, and
• ADAPTIVE RADIOTHERAPY.

IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice.
This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n.
This document describes measurements and test procedures to be performed by the manufacturer of light ion beam ME equipment but does not specify acceptance tests.
This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of light ion beam ME equipment and which are to be declared in the accompanying documentation together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of performance values is given in Annex A.

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.

IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of ME equipment intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n. Key words: nuclear medicine, radiation dosimetry.

IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. This third edition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.

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.

IEC 61217:2011 applies to equipment and data related to the process of teleradiotherapy, including patient image data used in relation with radiotherapy treatment planning systems, radiotherapy simulators, isocentric gamma beam therapy equipment, isocentric medical electron accelerators, and non-isocentric equipment when relevant. The object of this standard is to define a consistent set of coordinate systems for use throughout the process of teleradiotherapy, to define the marking of scales (where provided), to define the movements of equipment used in this process, and to facilitate computer control when used. This second edition cancels and replaces the first edition, published in 1996, amendment 1, published in 2000 and amendment 2, published in 2007. This edition constitutes a technical revision to include imager and focus coordinate systems in Subclause 3.12. Beyond this Subclause, changes were only introduced where needed to include the above coordinate systems.

IEC 60601-2-8:2010 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions:
- alignment with the new relevant collateral standards;
- new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).

IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems:
- for use in radiotherapy treatment planning in human medical practice;
- that imports data either through input by the operator or directly from other devices;
- that outputs data either in printed form for review or directly to other devices;
and which is intended to be:
a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training;
b) maintained in accordance with the recommendations given in the instructions for use, and
c) used within the environmental and electrical supply conditions specified in the technical description.
This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.

IEC/TR 60977:2008 applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This technical report applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. This second edition cancels and replaces the first edition published in 1989 and its Amendment 1 (2000). It constitutes a technical revision. This second edition likewise follows on the issue of a second edition to the disclosure standard IEC 60976 in 2007. It includes the addition of performance guidelines relating to several relatively new technologies introduced within the last few years, including dynamic beam delivery techniques, such as moving beam radiotherapy, intensity modulated radiation therapy (IMRT), image guided radiotherapy (IGRT), and programmable wedge fields (PWF). Also included are stereotactic radiotherapy (SRT)/stereotactic radiosurgery (SRS) and the use of certain electronic imaging devices (EIDs).

IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This standard applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests. The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods. This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients. Except where otherwise stated this standard assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted. This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: - dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields; - stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS); - use of electronic imaging devices. This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1.

Applies to the design and manufacture and some installation aspects of a record and verify system (RVS) for use in radiotherapy in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the operator or directly from other devices, b) may control the ability of that equipment to operate; c) records data of all treatment sessions; and d) is intended to be: 1) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; 2) maintained in accordance with the recommendations given in the instructions for use; and 3) used within the environmental and electrical supply conditions specified in the technical description.

This report is supplement 11 to the DICOM standard. It defines a number of information objects applicable to the domain of radiation oncology. The intent of these objects is to support the transfer of radiotherapy-related data between devices found within and outside a radiotherapy department.