IEC 60601-2-68:2014

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

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.

Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de radiothérapie à rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs d'électrons, les appareils de thérapie par faisceau d'ions légers et les appareils de thérapie par faisceau de radionucléides

L'IEC 60601-2-68:2014 s'applique à la sécurité de base et aux performances essentielles des appareils de radiothérapie assistée par imagerie médicale (IGRT) destinés à être utilisés avec les appareils de radiothérapie externes (EBE). La présente norme particulière couvre les aspects de sécurité des dispositifs d'imagerie à rayonnement X sous kilotension et sous mégatension dans une relation géométrique connue avec les EBE à des fins de IGRT. Elle couvre les aspects de communication et les relations entre les EBE et les dispositifs d'imagerie à rayonnement X fixés ou non directement fixés, mais présents dans la même zone protégée contre le rayonnement que les EBE, et dédiés à être utilisés uniquement avec ces appareils. La présente norme particulière traite des appareils de radiothérapie assistée par imagerie médicale en temps réel, en ligne et hors ligne. Elle couvre les procédures de réduction du risque de confiance excessive envers le système d'appareils de radiothérapie assistée par imagerie médicale. Par exemple, le fabricant fournit une interface interactive destinée à l'interaction des utilisateurs avec la correction proposée par le système.

General Information

• Status: Published
• Publication Date: 03-Sep-2014
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy 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: 30-Sep-2014
• Completion Date: 04-Sep-2014

Standards Content (Sample)

IEC 60601-2-68 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
Appareils électromédicaux –
Partie 2-68: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de radiothérapie à rayonnement X assistée par
imagerie médicale, destinés à être utilisés avec les accélérateurs d’électrons, les
appareils de thérapie par faisceau d’ions légers et les appareils de thérapie par
faisceau de radionucléides
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IEC 60601-2-68 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
Appareils électromédicaux –
Partie 2-68: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils de radiothérapie à rayonnement X assistée par

imagerie médicale, destinés à être utilisés avec les accélérateurs d’électrons, les

appareils de thérapie par faisceau d’ions légers et les appareils de thérapie par

faisceau de radionucléides
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.60 ISBN 978-2-8322-1839-6

– 2 – IEC 60601-2-68:2014 © IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 18
201.5 General requirements for testing ME EQUIPMENT . 19
201.6 Classification of me equipment and me systems . 19
201.7 ME EQUIPMENT identification, marking and documents . 19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 25
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 28
201.10 Protection against unwanted and excessive radiation HAZARDS . 32
201.11 Protection against excessive temperatures and other HAZARDS . 34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 34
201.13 Hazardous situations and fault conditions for me equipment . 34
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 35
201.15 Construction of me equipment. 35
201.16 ME SYSTEMS . 35
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
201.101 Reference data for X-IGRT . 36
201.102 X-IGRT IMAGING . 40
201.103 IGRT analysis and correction . 47
203 RADIATION protection in diagnostic X-RAY EQUIPMENT . 51
206 Usability . 52
Annex B (informative) Sequence of testing . 54
Annex I (informative) ME SYSTEMS aspects . 54
Annex AA (informative) Particular guidance and rationale . 55
Annex BB (informative) Measuring CTDI . 57
free air
Bibliography . 58
Index of defined terms used in this standard . 59

Figure 201.101 – PATIENT SUPPORT movements . 53

Table 201.101 – Data required in the technical description . 22
Table 201.102 – Clauses and subclauses in this particular standard that require the
provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and
the technical description . 23
Table 201.103 – Example test pattern for CTDI
for kV . 45
free air
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
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