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BS EN 60601-2-5:2015

BS EN 60601-2-5:2015

$167.15

Medical electrical equipment – Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

Published By Publication Date Number of Pages
BSI 2015 40
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This Particular Standard specifies requirements and tests for the safety of ultrasonic physiotherapy equipment. It amends and supplements IEC 60601-1 (second edition, 1988) including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular Standard takes into account IEC 60601-1-2 and IEC 61689.

PDF Catalog

PDF Pages PDF Title
4 European 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
11 INTRODUCTION
12 201.1 Scope, object and related standards
14 201.2 Normative references
201.3 Terms and definitions
17 201.4 General requirements
Table 201.101 – List of symbols used in this standard
18 201.5 General requirements for testing of me equipment
201.6 Classification of me equipment and me systems
201.7 *Me equipment identification, marking and documents
Table 201.102 – Distributed essential performance requirements
19 201.8 *Protection against electrical hazards from me equipment
20 201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
21 201.11 Protection against excessive temperatures and other hazards
24 201.12 Accuracy of controls and instruments and protection against hazardous outputs
Table 201.103 – Overview of the tests noted under 201.11.1.3
26 201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
27 201.16 ME systems
201.17 *Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic compatibility – Requirements and tests
28 Annexes
29 Annex AA (informative) Particular guidance and rationale
34 Annex BB (informative) Example set-up to measure surface temperature of externally applied transducer assemblies
Table BB.1 – Acoustic and thermal properties of tissues and materials
35 Table BB.2 – Weight % pure components
36 Figure BB.1 – Set-up of an example test object to measure the surface temperature of externally applied transducers
37 Bibliography
38 Index of defined terms used in this particular standard

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BS EN 60601-2-5:2015
$167.15