BS EN 62353:2008
$198.66
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2008 | 56 |
Applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems, or parts of such equipment or systems, which comply with IEC 60601-1, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such me equipment or me systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the me equipment or me system is designed. This standard contains: – “general requirements”, which contain clauses of general concern, and – “particular requirements”, further clauses handling special types of me equipment or me systems and applying in connection with the “General requirements”. This standard is also applicable to tests after repair. The testing shall be defined according to the extent of work performed and applicable guidance from the manufacturer.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | CONTENTS |
| 7 | 1 Scope |
| 8 | 2 Normative references 3 Terms and definitions |
| 15 | 4 Requirements 4.1 General requirements |
| 16 | 4.2 Testing before putting into service, after modifications, and after repair |
| 17 | 4.3 Recurrent test 5 Tests 5.1 General 5.2 Visual inspection |
| 18 | 5.3 Measurements |
| 19 | Figures Figure 1 – Measuring circuit for the measurement of protective earth resistance in me equipment that is disconnected from the supply mains |
| 20 | Figure 2 – Measuring circuit for the measurement of protective earth resistance in me equipment or me system, which for functional reasons cannot be disconnected from supply mains, or in ME equipment or ME system permanently connected to mains |
| 21 | Table 1 – Legends of symbols |
| 23 | Figure 3 – Measuring circuit for the measurement of equipment leakage current – alternative method |
| 24 | Figure 4 – Measuring circuit for the measurement of equipment leakage current – direct method |
| 25 | Figure 5 – Measuring circuit for the measurement equipment leakage current – differential method |
| 26 | Figure 6 – Measuring circuit for the measurement of applied part leakage current “f-type applied part” – alternative method |
| 27 | Figure 7 – Measuring circuit for the measurement of applied part leakage current – mains voltage on f-type applied part – direct method Figure 8 – Measuring circuit for the measurement of applied part leakage current for equipment with an internal electrical power source – direct method |
| 28 | Table 2 – Allowable values for leakage currents |
| 29 | Figure 9 – Measuring circuit for the measurement of the insulation resistance between mains part and protective earth for class I equipment and between mains part and (non-earthed) accessible conductive parts for class I and class II equipment Figure 10 – Measuring circuit for measurement of the insulation resistance between mains part and applied parts which make a patient connection |
| 30 | 5.4 Functional test Figure 11 – Measuring circuit for measurement of the insulation resistance between f-type applied parts which make a patient connection and protective earth for class I equipment and between f-type applied parts which make a patient connection and (non-earthed) accessible conductive parts for class I and class II equipment |
| 31 | 6 Results of test and evaluation 6.1 Reporting of results 6.2 Evaluation |
| 32 | Annex A (informative) General guidance and rationale Table A.1 – Addressees and their possible interest in this standard |
| 36 | Table A.2 – Reasons for choosing different measuring methods |
| 39 | Annex B (informative) Sequence of testing Figure B.1 – Sequence of testing |
| 40 | Figure B.2 – Measurement of leakage currents (class I ME equipment) |
| 41 | Figure B.3 – Measurement of leakage currents (class II ME equipment and accessible conductive parts of class I ME equipment, which are not connected to protective earth) |
| 42 | Annex C (normative) Requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents |
| 44 | Figure C.1 – Example of a measuring device and its frequency characteristics |
| 45 | Annex D (informative) Patient environment Figure D.1 – Example of patient environment |
| 46 | Annex E (informative) Allowable values for leakage currents from IEC 60601-1 Table E.1 – Allowable values for continuous leakage currents from IEC 60601-1:1988 |
| 47 | Table E.2 – Allowable values for touch currents, earth leakage currents, patient leakage currents and patient auxiliary currents under normal condition and single fault condition from IEC 60601-1:2005 |
| 48 | Table E.3 – Allowable values for patient leakage currents under the special test conditions identified in 8.7.4.7 of IEC 60601-1:2005 |
| 49 | Annex F (informative) Testing intervals |
| 50 | Annex G (informative) Example of test documentation Figure G.1 – Example of test documentation |
| 51 | Bibliography |
| 52 | Index of defined terms |
