BS EN 60601-1-2:2015
$227.44
Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 102 |
IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: – specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments; – specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; – specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; – specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and – better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”. This new edition includes the following main additions: – guidance for determination of immunity test levels for special environments; – guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; – guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and – guidance on identification of immunity pass/fail criteria.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 12 | English CONTENTS |
| 16 | FOREWORD |
| 19 | INTRODUCTION |
| 21 | 1 Scope, object and related standards 1.1 * Scope 1.2 Object 1.3 Related standards 1.3.1 IEC 60601-1 1.3.2 Particular standards 2 Normative references |
| 23 | 3 Terms and definitions |
| 27 | 4 General requirements 4.1 Risk management process for me equipment and me systems 4.2 * Non-me equipment used in an me system 4.3 General test conditions 4.3.1 * Configurations |
| 28 | 4.3.2 Artificial hand 4.3.3 * Power input voltages and frequencies Figures Figure 1 – RC element of the artificial hand |
| 29 | Tables Table 1 – Power input voltages and frequencies during the tests (1 of 2) |
| 30 | 5 Me equipment and me systems identification, marking and documents 5.1 Additional requirements for marking on the outside of me equipment and me systems that are specified for use only in a shielded location special environment 5.2 Accompanying documents 5.2.1 Instructions for use |
| 31 | 5.2.2 Technical description |
| 33 | 6 Documentation of the tests 6.1 General 6.2 Test plan 6.3 Test report 7 Electromagnetic emissions requirements for me equipment and me systems 7.1 Protection of radio services and other equipment 7.1.1 * General 7.1.2 Operating modes |
| 34 | 7.1.3 Multimedia equipment 7.1.4 * Subsystems 7.1.5 Me equipment and me systems specified for use only in a shielded location special environment 7.1.6 Me equipment and me systems that include radio equipment |
| 35 | 7.1.7 * Me equipment whose main functions are performed by motors and switching or regulating devices 7.1.8 Me equipment and me systems containing X-ray generators 7.1.9 Patient physiological simulation 7.1.10 Artificial hand 7.1.11 Patient-coupled cables 7.1.12 Permanently installed large me equipment and large me systems |
| 36 | 7.2 Protection of the public mains network 7.2.1 * Harmonic distortion 7.2.2 * Voltage fluctuations and flicker 7.3 Emissions requirements summary Table 2 – Emission limits per environment |
| 37 | 8 Electromagnetic immunity requirements for me equipment and me systems 8.1 * General Figure 2 – Ports of me equipment and me systems |
| 38 | Table 3 – Procedure for continuing to test me equipment or me systems that are damaged by an immunity test signal |
| 40 | 8.2 Patient physiological simulation 8.3 Termination of patient-coupled parts 8.4 Hand-held me equipment and parts intended to be hand-held |
| 41 | 8.5 * Subsystems 8.6 Permanently installed large me equipment and large me systems 8.7 * Operating modes |
| 42 | 8.8 * Non-me equipment 8.9 * Immunity test levels |
| 43 | Figure 3 – Examples of environments of intended use |
| 44 | Table 4 – * Enclosure port |
| 45 | Table 5 – * Input a.c. power port (1 of 2) |
| 47 | Table 6 – Input d.c. power port |
| 48 | Table 7 – * Patient coupling port |
| 49 | 8.10 * Immunity to proximity fields from RF wireless communications equipment Table 8 – Signal input/output parts port |
| 50 | Table 9 – Test specifications for enclosure port immunity to RF wireless communications equipment |
| 51 | 9 * Test report Table 10 – * Minimum test report contents (1 of 2) |
| 53 | Annex A (informative) General guidance and rationale A.1 Safety and performance A.2 Testing of normally non-observable functions A.3 Rationale for particular clauses and subclauses |
| 57 | Figure A.1 – Examples of ports (from IEC 61000-6-1:2005) |
| 59 | Table A.1 – IEC/TR 61000-2-5 information considered in specifying immunity test levels for each immunity test |
| 64 | Figure A.2 – IEC 61000-4-2 Figure A.1 – Maximum values of electrostatic voltages to which operators can be charged while in contact with the materials mentioned in A.2 |
| 67 | Annex B (informative) Guide to marking and labelling requirementsfor me equipment and me systems B.1 Marking on the outside of me equipment, me systems or their parts B.2 Accompanying documents, instructions for use B.3 Accompanying documents, technical description Table B.1 – Marking on the outside of me equipment, me systems or their parts Table B.2 – Accompanying documents, instructions for use |
| 68 | Table B.3 – Accompanying documents, technical description |
| 69 | Annex C (informative) Guidance in classification according to CISPR 11 C.1 General C.2 Separation into groups |
| 70 | C.3 Division into classes |
| 71 | Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular standards D.1 General D.2 Recommended modifications D.2.1 Testing requirements D.2.2 Accompanying documents D.3 Cautions |
| 73 | Annex E (informative) Determination of immunity test levels for special environments E.1 General |
| 74 | Figure E.1 – Test plan development flow when special environments are known |
| 75 | Figure E.2 – Sub-process for determination of immunity test levels for special environments |
| 76 | E.2 Summary of method for E.1 a) E.3 Summary of method for E.1 b), c) and d) E.4 Determination of em disturbance level reduction E.5 Assessment of em disturbance sources |
| 77 | E.6 Reasonably foreseeable maximum em disturbance levels E.7 Determination of immunity test levels E.8 RF radiators in special environments |
| 78 | E.9 Examples of mitigations and special conditions Table E.1 – Examples of specific mitigations / environmental conditions |
| 79 | Annex F (informative) Risk management for basic safety and essential performance with regard to electromagnetic disturbances F.1 General Figure F.1 – Function of this collateral standard in the risk management process |
| 80 | F.2 General requirements for risk management Figure F.2 – Examples of multiple verification methods for improving confidence in risk levels |
| 81 | F.3 Risk analysis |
| 82 | Table F.1 – Examples of EM phenomena that should be considered in a risk analysis |
| 84 | F.4 Risk evaluation |
| 85 | F.5 Risk control F.5.1 Risk control option analysis F.5.2 Implementation of risk control measure(s) F.5.3 Residual risk evaluation |
| 86 | F.5.4 Risk/benefit analysis F.5.5 Risks arising from risk control measures F.5.6 Completeness of risk control F.6 Evaluation of overall residual risk acceptability F.7 Risk management report |
| 87 | F.8 Production and post-production information |
| 88 | Annex G (informative) Guidance: Test plan G.1 Test plan contents Table G.1 – Recommended minimum test plan contents (1 of 2) |
| 90 | Annex H (informative) Patient-coupled cables emissions H.1 * Protection of other equipment from patient cable conducted emissions H.2 Test method H.3 Rationale Table H.1 – Patient-coupled conducted emissions recommended limit |
| 91 | Figure H.1 – Setup for patient-coupled cables conducted emissions test for me equipment and me systems that conform to IEC 60601-2-27 |
| 92 | Annex I (informative) Identification of immunity pass/fail criteria I.1 General I.2 Immunity pass/fail criteria principles I.2.1 General I.2.2 Immunity pass/fail criteria for non-me equipment used in an me system I.2.3 Immunity pass/fail criteria determination |
| 93 | I.3 Immunity pass/fail criteria examples I.3.1 General examples |
| 94 | I.3.2 Example of immunity pass/fail criteria for a radiological table system |
| 95 | Table I.1 – Example of immunity pass criteria for a radiological table system |
| 96 | Bibliography |
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