IEC TR 60977:2008

Medical electrical equipment - Medical electron accelerators - Guidelines for functional performance characteristics

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).

Appareils électromédicaux - Accélérateurs médicaux d'électrons - Lignes directrices pour les caractéristiques des performances fonctionnelles

La CEI/TR 60977:2008 s'applique aux accélérateurs médicaux d'électrons utilisés à des fins thérapeutiques, en médecine humaine. Le présent rapport technique s'applique aux accélérateurs médicaux d'électrons délivrant un faisceau de rayonnement soit rayonnement X soit rayonnement électronique avec des énergies nominales comprises dans la gamme de 1 MeV à 50 MeV avec un débit de dose absorbée maximum de 0,001 Gy s-1 à 1 Gy s-1 à 1 m de la source de rayonnement et à une distance normale de traitement entre 50 cm et 200 cm de la source de rayonnement. Cette deuxième édition annule et remplace la première édition parue en 1989 ainsi que son amendement 1 (2000). Elle constitue une révision technique. Cette seconde édition fait suite à la publication de la seconde édition de la norme de déclaration CEI 60976 de 2007. Elle comprend l'ajout de lignes directrices de performances en rapport avec plusieurs technologies relativement nouvelles introduites au cours de ces dernières années, comprenant des techniques de transmissions du faisceau dynamiques, telles que la radiothérapie par faisceau mobile, radiothérapie de conformation avec modulation d'intensité de dose (IMRT), la radiothérapie assistée par imagerie médicale (IGRT), et les faisceaux avec filtres en coin programmables (PWF). Les techniques suivantes ont également été incluses: radiothérapie stéréotaxique (SRT)/ radiochirurgie stéréotaxique (SRS) et utilisation de certains dispositifs d'imagerie électroniques (EID).

General Information

• Status: Published
• Publication Date: 08-Jul-2008
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 1 - TC 62/SC 62C/WG 1
• Current Stage: PPUB - Publication issued
• Start Date: 31-Aug-2008
• Completion Date: 09-Jul-2008

Relations

• Revises: IEC TR 60977:1989/AMD1:2000 - Amendment 1 - Medical electrical equipment - Medical electron accelerators in the range 1 MeV to 50 MeV - Guidelines for functional performance characteristics
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC/TR 60977
Edition 2.0 2008-07
TECHNICAL
REPORT
RAPPORT
TECHNIQUE
Medical electrical equipment – Medical electron accelerators – Guidelines for
functional performance characteristics

Appareils électromédicaux – Accélérateurs médicaux d’électrons – Lignes
directrices pour les caractéristiques des performances fonctionnelles

IEC/TR 60977:2008
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IEC/TR 60977
Edition 2.0 2008-07
TECHNICAL
REPORT
RAPPORT
TECHNIQUE
Medical electrical equipment – Medical electron accelerators – Guidelines for
functional performance characteristics

Appareils électromédicaux – Accélérateurs médicaux d’électrons – Lignes
directrices pour les caractéristiques des performances fonctionnelles

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.50 ISBN 2-8318-9893-5
– 2 – TR 60977 © IEC:2008
CONTENTS
FOREWORD.3
INTRODUCTION.5
1 Scope.7
2 Normative references .7
3 General, type tests .7
3.1 Format of Annex A of the disclosure standard with suggested functional
performance values.7
3.2 Rationale for functional performance values suggested by the Working
Group.30
3.2.1 Introduction .30
3.2.2 IEC 60976, Clause 6.30
3.2.3 Suggested functional performance values.30
4 Acceptance tests .39
4.1 General .39
4.2 Summary of suggested test methods for MEDICAL ELECTRON ACCELERATOR
acceptance.41
4.3 Acceptance test conditions.50
4.4 Suggested equipment for acceptance tests and for subsequent periodic tests .59
4.4.1 Introduction .59
4.4.2 Item description.59
5 Periodic tests .59
5.1 Introduction .59
5.2 Suggested set of periodic test methods and test conditions.61
5.3 Suggested frequency for periodic tests during working life of the ELECTRON
ACCELERATOR.66
Bibliography.68

Figure 1 – Cumulative errors in beam displacement.39
Figure 2 – Phantom position .41
Figure 3 – DOSE MONITORING SYSTEM proportionality.43

Table 1 – Summary of major tolerances in routine X-RAY THERAPY .38
Table 2 – Suggested set of periodic test methods and test conditions.61

TR 60977 © IEC:2008 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
MEDICAL ELECTRON ACCELERATORS –
GUIDELINES FOR FUNCTIONAL PERFORMANCE
CHARACTERISTICS
FOREWORD
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The main task of IEC technical committees is to prepare International Standards. However, a
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data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 60977, which is a technical report, has been prepared by subcommittee 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
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

– 4 – TR 60977 © IEC:2008
FIELDS (PWF). Also included are STEREOTACTIC RADIOTHERAPY (SRT)/STEREOTACTIC
RADIOSURGERY (SRS) and the use of certain ELECTRONIC IMAGING DEVICES (EIDs).
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62C/424/DTR 62C/439/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
TR 60977 © IEC:2008 – 5 –
INTRODUCTION
The guidelines given in this report are recommendations both to manufacturers and to USERS.
They provide guidance to MANUFACTURERS on the needs of USERS in respect of the
performance of ELECTRON ACCELERATORS and they provide guidance to USERS wishing to
...