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BS EN 60601-2-11:2015

BS EN 60601-2-11:2015

$198.66

Medical electrical equipment – Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

Published By Publication Date Number of Pages
BSI 2015 56
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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.

PDF Catalog

PDF Pages PDF Title
4 Foreword
Endorsement notice
5 Annex ZA (normative) Normative references to international publications with their corresponding European publications
6 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives
7 English
CONTENTS
8 FOREWORD
10 INTRODUCTION
11 201.1 Scope, object and related standards
12 201.2 Normative references
13 201.3 Terms and definitions
16 201.4 General requirements
17 201.5 General requirements for testing of me equipment
201.6 Classification of me equipment and me systems
18 201.7 Me equipment identification, marking and documents
19 Table 201.101 – Colours of treatment control panel
Table 201.102 – Subclauses in this particular standard requiring the provision of information in the accompanying documents, instructions for use and the technical description
22 Table 201.103 – Subclauses where data is described that is required in the technical description to support Clause 201.10 site test compliance
23 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
25 201.10 Protection against unwanted and excessive radiation hazards
43 201.11 Protection against excessive temperatures and other hazards
44 201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions
45 201.15 Construction of me equipment
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
Figure 201.101 – Leakage radiation
47 Figure 201.102 – Points for the measurement of average leakage
48 Figure 201.103 – Test plane orthogonal to the radiation beam axis at the normal treatment distance
Figure 201.104 – Location of test points for site test of item 201.10.2.5.2.2
49 Figure 201.105 – Matrix measurement points for beam off and beam on conditions to be specified at the floor level, isocenter level and 1 m above the isocenter level (see requirement 201.10.2.4.2)
50 Annexes
Annex B (informative) Sequence of testing
51 Index of defined terms used in this particular standard

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BS EN 60601-2-11:2015
$198.66