IEC 60601-2-64:2014

Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

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.

Appareils électromédicaux - Partie 2-64: Exigences particulières pour la sécurité de base et les performances essentielles des appareils électromédicaux par faisceau d'ions légers

L'IEC 60601-2-64:2014 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux par Faisceau d'Ions Légers, désignés ci-après par le terme appareils EM, utilisés pour le traitement des patients. La présente norme particulière, y compris les essais de type et les essais sur le site, s'applique respectivement au fabricant et à certains aspects d'installation des appareils EM par Faisceau d'Ions Légers destinés à être utilisés à des fins de radiothérapie dans la médecine humaine, y compris les appareils dont le choix et l'affichage des paramètres de fonctionnement peuvent être contrôlés automatiquement par des sous-systèmes électroniques programmables qui, en utilisation normale, délivrent un faisceau de rayonnement d'ions légers dont l'énergie par nucléon se situe dans la gamme 10 MeV/n à 500 MeV/n. Mots clé: médecine nucléaire, dosimétrie de radiations.

General Information

• Status: Published
• Publication Date: 02-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: 15-Sep-2014
• Completion Date: 03-Sep-2014

Standards Content (Sample)

IEC 60601-2-64 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-64: Particular requirements for the basic safety and essential
performance of light ion beam medical electrical equipment

Appareils électromédicaux –
Partie 2-64: Exigences particulières pour la sécurité de base et
les performances essentielles des appareils électromédicaux par faisceau
d'ions légers
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IEC 60601-2-64 ®
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-64: Particular requirements for the basic safety and essential

performance of light ion beam medical electrical equipment

Appareils électromédicaux –
Partie 2-64: Exigences particulières pour la sécurité de base et

les performances essentielles des appareils électromédicaux par faisceau

d'ions légers
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.60 ISBN 978-2-8322-1825-9

– 2 – IEC 60601-2-64:2014  IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 14
201.5 General requirements for testing of ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 45
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 45
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 46
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 46
201.15 Construction of ME EQUIPMENT . 46
201.16 ME SYSTEMS . 46
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 46
201.101 ELECTRONIC IMAGING DEVICES (EID) . 47
206 Usability . 47
Annexes . 50
Annex B (informative) Sequence of testing . 50
Annex I (informative) ME SYSTEMS aspects . 50
Bibliography . 51
Index of defined terms used in this particular standard. 52

Figure 201.101 – PATIENT SUPPORT movements . 48
Figure 201.102 – Diagram illustrating example RADIATION HEAD components and
possible PATIENT position for NON-PRIMARY RADIATION REQUIREMENTS . 49
Figure 201.103 – Diagram illustrating distance along PATIENT plane to measure
NON-PRIMARY RADIATION ABSORBED DOSE . 49

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 17

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Particular requirements for the basic safety
and essential performance of LIGHT ION BEAM ME EQUIPMENT

FOREWORD
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International Standard IEC 60601-2-64 has been prepared by subcommittee 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/594/FDIS 62C/600/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.

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