BSI PD IEC TS 60601-4-2:2024 – TC
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Tracked Changes. Medical electrical equipment – Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
| Published By | Publication Date | Number of Pages |
| BSI | 2024 | 131 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 71 | undefined |
| 73 | CONTENTS |
| 76 | FOREWORD |
| 79 | INTRODUCTION 0.1 * General 0.2 Purpose of this document 0.3 How to use this document |
| 80 | 0.4 Immunity test levels |
| 81 | 1 Scope 2 Normative references |
| 83 | 3 Terms and definitions |
| 86 | 4 General recommendations 4.1 Concurrent and sequential testing 4.2 General test conditions 4.2.1 Configurations |
| 87 | 4.2.2 Artificial hand Figures Figure 1 – RC element of the artificial hand |
| 88 | 4.2.3 Power input voltages and frequencies 5 Me equipment and me systems identification, marking and documents 5.1 Marking on the outside of me equipment or me equipment parts for which the connector testing exemption specified in 8.13.2 d) is used 5.2 ACCOMPANYING DOCUMENTS 5.2.1 General 5.2.2 Instructions for use 5.2.3 Requirements applicable to me equipment and me systems for which the connector testing exemption specified in 8.13.2 d) is used |
| 89 | 5.2.4 * Technical description 6 Documentation of the tests 6.1 Test plan Tables Table 1 – Recommended minimum test plan |
| 90 | 6.2 Test report 7 * Emissions 8 Immunity recommendations 8.1 General |
| 91 | 8.2 Patient physiological simulation Figure 2 – * Ports of me equipment and me systems |
| 92 | 8.3 Termination of patient-coupled parts 8.4 Hand-held me equipment and parts intended to be hand-held 8.5 Subsystems 8.6 Permanently installed large me equipment and large me systems |
| 93 | 8.7 Operating modes 8.8 Non-me equipment 8.9 * Environments of intended use |
| 94 | 8.10 * Performance criteria 8.11 * IMMUNITY TEST LEVELS |
| 96 | Figure 3 – Examples of locations within em environments |
| 97 | Table 2 – * Enclosure port |
| 98 | Table 3 – * Input AC power port |
| 99 | Table 4 – Input DC power port |
| 100 | Table 5 – * Patient coupling port Table 6 – Sip/sop port |
| 101 | 8.12 * Immunity to proximity fields from RF wireless communications equipment Table 7 – Test specifications for enclosure port immunity to RF wireless communications equipment |
| 102 | 8.13 * ESD testing of connectors 8.13.1 Application of ESD to connectors Table 8 – Parts of connectors to be tested for ESD, based on theconnector shell and cover material Table 9 – * Testing of connectors and pins while connected and disconnected |
| 103 | 8.13.2 Exclusions 8.14 Test report Table 10 – Test report minimum contents |
| 105 | Annex A (informative)General guidance and rationale |
| 109 | Table A.1 – Assumptions used in determining immunity test levelsspecified in Table 7 |
| 111 | Annex B (informative)Guide to labelling recommendations B.1 Accompanying documents, instructions for use B.2 Accompanying documents, technical description Table B.1 – accompanying documents, instructions for use Table B.2 – Accompanying documents, technical description |
| 112 | Annex C (informative)Determination of immunity test levels for special environments C.1 General |
| 113 | C.2 EM disturbance level determination C.3 Assessment of em disturbance sources C.4 Test methods C.5 Test plan |
| 114 | C.6 Examples of mitigations and special conditions Table C.1 – Examples of adjusted immunity test levels due to mitigations or special conditions |
| 115 | Annex D (informative)Identification of specific immunity performance criteria D.1 General D.2 Immunity performance criteria principles D.2.1 General D.2.2 Immunity performance criteria for non-me equipment used in an me system D.2.3 Immunity performance criteria determination D.3 Immunity performance criteria examples D.3.1 General examples |
| 117 | D.3.2 Example of immunity performance criteria for a radiological table system D.3.3 Example of immunity performance criteria for ultrasonic diagnostic equipment Table D.1 – Example of immunity performance criteriafor a radiological table and gantry system |
| 118 | Table D.2 – Example of immunity performance criteria forultrasonic diagnostic equipment |
| 119 | Annex E (informative)Performance criteria specified by IEC 61000-6-x generic EMC standards |
| 120 | Annex F (informative)Mapping between this document and the elements ofIEC 6060112:2014 and IEC 6060112:2014/AMD1:2020 Table F.1 – Mapping between the elements of this document andIEC 60601-1-2:2014 and IEC 6060112:2014/AMD1:2020 |
| 126 | Bibliography |
| 128 | Index of defined terms used in this document |
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