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eLibrary > PD IEC TS 60601-4-2:2024 - TC Tracked Changes. Medical electrical equipment - Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems >

PD IEC TS 60601-4-2:2024 - TC Tracked Changes. Medical electrical equipment - Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, 2024

PD IEC TS 60601-4-2:2024 - TC Tracked Changes. Medical electrical equipment - Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, 2024

A-30490449.pdf [Go to Page]
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CONTENTS
FOREWORD
INTRODUCTION [Go to Page]
0.1 * General
0.2 Purpose of this document
0.3 How to use this document
0.4 Immunity test levels
1 Scope
2 Normative references
3 Terms and definitions
4 General recommendations [Go to Page]
4.1 Concurrent and sequential testing
4.2 General test conditions [Go to Page]
4.2.1 Configurations
4.2.2 Artificial hand
Figures [Go to Page]
Figure 1 – RC element of the artificial hand [Go to Page]
4.2.3 Power input voltages and frequencies
5 Me equipment and me systems identification, marking and documents [Go to Page]
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 [Go to Page]
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
6 Documentation of the tests [Go to Page]
6.1 Test plan
Tables [Go to Page]
Table 1 – Recommended minimum test plan
6.2 Test report
7 * Emissions
8 Immunity recommendations [Go to Page]
8.1 General
8.2 Patient physiological simulation
Figure 2 – * Ports of me equipment and me systems
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
8.7 Operating modes
8.8 Non-me equipment
8.9 * Environments of intended use
8.10 * Performance criteria
8.11 * IMMUNITY TEST LEVELS
Figure 3 – Examples of locations within em environments
Table 2 – * Enclosure port
Table 3 – * Input AC power port
Table 4 – Input DC power port
Table 5 – * Patient coupling port
Table 6 – Sip/sop port
8.12 * Immunity to proximity fields from RF wireless communications equipment
Table 7 – Test specifications for enclosure port immunity to RF wireless communications equipment
8.13 * ESD testing of connectors [Go to Page]
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 [Go to Page]
8.13.2 Exclusions
8.14 Test report
Table 10 – Test report minimum contents
Annex A (informative)General guidance and rationale [Go to Page]
Table A.1 – Assumptions used in determining immunity test levelsspecified in Table 7
Annex B (informative)Guide to labelling recommendations [Go to Page]
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
Annex C (informative)Determination of immunity test levels for special environments [Go to Page]
C.1 General
C.2 EM disturbance level determination
C.3 Assessment of em disturbance sources
C.4 Test methods
C.5 Test plan
C.6 Examples of mitigations and special conditions
Table C.1 – Examples of adjusted immunity test levels due to mitigations or special conditions
Annex D (informative)Identification of specific immunity performance criteria [Go to Page]
D.1 General
D.2 Immunity performance criteria principles [Go to Page]
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 [Go to Page]
D.3.1 General examples
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
Table D.2 – Example of immunity performance criteria forultrasonic diagnostic equipment
Annex E (informative)Performance criteria specified by IEC 61000-6-x generic EMC standards
Annex F (informative)Mapping between this document and the elements ofIEC 6060112:2014 and IEC 6060112:2014/AMD1:2020 [Go to Page]
Table F.1 – Mapping between the elements of this document andIEC 60601-1-2:2014 and IEC 6060112:2014/AMD1:2020
Bibliography
Index of defined terms used in this document [Go to Page]

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PD IEC TS 60601-4-2:2024 - TC Tracked Changes. Medical electrical equipment - Guidance and interpretation. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, 2024

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