BSI PD IEC/TR 60601-4-2:2016
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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 | 2016 | 62 |
IEC TR 60601-4-2:2016(E) applies to the performance of medical electrical equipment or a medical electrical system in the presence of electromagnetic disturbances.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | CONTENTS |
| 7 | FOREWORD |
| 10 | INTRODUCTION 0.1 * General 0.2 Purpose of this document 0.3 How to use this document |
| 11 | 0.4 Immunity test levels |
| 12 | 1 Scope and object 1.1 Scope 1.2 Object 2 Normative references |
| 13 | 3 Terms and definitions |
| 17 | 4 General recommendations 4.1 Concurrent and sequential testing 4.2 General test conditions 4.2.1 Configurations 4.2.2 Artificial hand |
| 18 | 4.2.3 Power input voltages and frequencies Figures FigureĀ 1Ā ā RC element of the artificial hand |
| 19 | 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 5.2.4 * Technical description |
| 20 | 6 Documentation of the tests 6.1 Test plan Tables TableĀ 1Ā ā Recommended minimum test plan (1 of 2) |
| 21 | 6.2 Test report 7 * Emissions 8 Immunity recommendations 8.1 General |
| 22 | 8.2 Patient physiological simulation FigureĀ 2Ā ā *Ā Ports of me equipment and me systems |
| 23 | 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 |
| 24 | 8.7 Operating modes 8.8 Non-me equipment 8.9 * Environments of intended use |
| 25 | 8.10 * Performance criteria 8.11 * Immunity test levels |
| 27 | FigureĀ 3Ā ā Examples of environments (locations) of intended use |
| 28 | TableĀ 2Ā ā *Ā Enclosure port TableĀ 3Ā ā *Ā Input AC power port (1 of 2) |
| 30 | TableĀ 4Ā ā Input DC power port |
| 31 | TableĀ 5Ā ā *Ā Patient coupling port |
| 32 | 8.12 * Immunity to proximity fields from RF wireless communications equipment TableĀ 6Ā ā Signal input/output parts port |
| 33 | 8.13 * ESD testing of connectors 8.13.1 Application of ESD to connectors TableĀ 7Ā ā Test specifications for enclosure port immunity to RF wireless communications equipment |
| 34 | 8.13.2 Exclusions Table 8 ā Parts of connectors to be tested for ESD, based on the connector shell and cover material TableĀ 9Ā ā *Ā Testing of connectors and pins while connected and disconnected |
| 35 | 9 Test report TableĀ 10Ā ā Test report minimum contents (1 of 2) |
| 37 | Annexes Annex A (informative) General guidance and rationale |
| 40 | TableĀ A.1Ā ā Assumptions used in determining immunity test levelsspecified in TableĀ 7 (1 of 2) |
| 42 | Annex B (informative) Guide to labelling recommendations B.1 Accompanying documents, instructions for use B.2 Accompanying documents, technical description TableĀ B.1 ā accompanying documents, instructions for use TableĀ B.2 ā Accompanying documents, technical description |
| 43 | Annex C (informative) Determination of immunity test levels for special environments C.1 General |
| 44 | C.2 em disturbance level determination C.3 Assessment of em disturbance sources C.4 Test methods C.5 Test plan |
| 45 | C.6 Examples of mitigations and special conditions TableĀ C.1Ā ā Examples of adjusted immunity test levels due to mitigations or special conditions |
| 46 | 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 |
| 48 | 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 ā Example of immunity performance criteria for a radiological table and gantry system |
| 49 | Table D.2 ā Example of immunity performance criteria for ultrasonic diagnostic equipment |
| 50 | Annex E (informative) Performance criteria specified by IEC 61000-6-x generic EMC standards |
| 51 | Annex F (informative) Mapping between this document and the elements of IEC 60601-1-2:2014 TableĀ F.1Ā ā Mapping between the elements of IECĀ TR 60601-4-2 andIECĀ 60601-1-2:2014 (1 of 5) |
| 56 | Bibliography |
| 58 | Index of defined terms used in this technical report |
