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BS EN IEC 60601-2-35:2021+A1:2024

BS EN IEC 60601-2-35:2021+A1:2024

$215.11

Medical electrical equipment – Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Published By Publication Date Number of Pages
BSI 2024 76
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PDF Pages PDF Title
2 undefined
5 Blank Page
6 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7 English
CONTENTS
9 FOREWORD
12 INTRODUCTION
13 201.1 Scope, object and related standards
15 201.2 Normative references
201.3 Terms and definitions
16 Figures
Figure 201.101 – Positioning of temperature sensors on the contact surfaceof the heated area of a heating device(see 201.12.4.101 and 201.12.4.105)
17 Figure 201.102 – Example of the positioning of temperature sensorson the contact surface of the heated areas of a heating device havingmore than one separately heated area
18 201.4 General requirements
19 201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
Tables
Table 201.101 – * Additional essential performance requirements
23 201.8 Protection against electrical hazards from me equipment
27 Figure 201.103 – Apparatus for the spark ignition test
29 201.9 Protection against mechanical hazards of me equipment and me systems
Figure 201.104 – Ramp for the impact test on pads
31 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
Figure 201.105 – Partial covering conditions
33 201.12 Accuracy of controls and instruments and protection against hazardous outputs
38 201.13 Hazardous situations and fault conditions for me equipment
40 Figure 201.106 – Method of folding blankets
42 Figure 201.107 – Examples of folds
43 201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
44 Table 201.102 – Temperature limits in dependency to time
47 201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
Figure 201.108 – Positions of a blanket for the ruck-resistance test
48 202 Electromagnetic disturbances – Requirements and tests
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
210 * Requirements for the development of physiologic closed-loop controllers
49 Annexes
Annex D(informative)Symbols on marking
50 Annex AA (informative)Particular guidance and rationale
Figure AA.1 – Illustration of the main requirements of this document
62 Annex BB (normative)Determination of the lagging material
63 Annex CC (normative)* Determination of heat transfer towards the patient
65 Annex DD (normative)* Determination of heat transfer away from the patient
66 Annex EE (normative)Conditions of adequate heat discharge
67 Annex FF (normative)Test procedure for maximum contact surface temperature for forced air devices
69 Annex GG (normative)Test procedure for maximum contact surface temperaturefor forced air devices under single fault condition
70 Annex HH (normative)Safety test procedure for average contact surfacetemperature for forced air devices
71 Figure HH.1 – Sensor locations – Average contact surface temperature
72 Bibliography
74 Index of defined terms used in this document

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BS EN IEC 60601-2-35:2021+A1:2024
$215.11