| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 11<\/td>\n | 1 Scope, object and related standards 1.1 *\u00a0Scope 1.2 Object 1.3 Related standards 1.3.1 IEC\u00a060601-1 1.3.2 Particular standards 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4 General requirements 4.1 General requirements for electromagnetic compatibility of me\u00a0equipment and me\u00a0systems 4.1.1 *\u00a0Electromagnetic compatibility <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.1.2 Electrical equipment that is not me\u00a0equipment 4.2 *\u00a0Single fault condition for me\u00a0equipment 5 Identification, marking and documents 5.1 Marking on the outside of me\u00a0equipment or me\u00a0equipment parts 5.1.1 *\u00a0Marking on the outside of me\u00a0equipment or me\u00a0equipment parts that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment 5.1.2 Marking on the outside of me\u00a0equipment or me\u00a0equipment parts for which the connector testing exemption specified in 6.2.2.2\u00a0c) is used 5.1.3 Marking on the outside of me\u00a0equipment and me\u00a0systems that are specified for use only in a shielded location <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.2 Accompanying documents 5.2.1 Instructions for use 5.2.1.1 Requirements applicable to all me\u00a0equipment and me\u00a0systems 5.2.1.2 Requirements applicable to me\u00a0equipment and me\u00a0systems for which the connector testing exemption specified in 6.2.2.2\u00a0c) is used 5.2.1.3 Minimum amplitude or value of patient physiological signal 5.2.1.4 *\u00a0Requirements applicable to type a professional me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.2.2 Technical description 5.2.2.1 Requirements applicable to all me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.2.2.2 *\u00a0Requirements applicable to me\u00a0equipment and me\u00a0systems other than those specified for use only in a shielded location <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 5.2.2.3 Requirements applicable to me\u00a0equipment and me\u00a0systems specified for use only in a shielded location <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 5.2.2.4 Requirements applicable to me\u00a0equipment and me\u00a0systems that intentionally apply RF energy for diagnosis or treatment <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 5.2.2.5 Requirements applicable to me\u00a0equipment and me\u00a0systems that intentionally receive RF electromagnetic energy for the purpose of their operation 5.2.2.6 Requirements applicable to me\u00a0equipment and me\u00a0systems that include RF transmitters <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 5.2.2.7 *\u00a0Requirements applicable to cables, transducers and other accessories that could affect compliance with the requirements of 6.1 and 6.2 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 5.2.2.8 Requirements applicable to large, permanently-installed me\u00a0equipment and me\u00a0systems 5.2.2.9 Requirements applicable to me\u00a0equipment and me\u00a0systems found to have no essential performance 5.2.2.10 *\u00a0Requirements applicable to type a professional me\u00a0equipment and me\u00a0systems <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 6 Electromagnetic compatibility 6.1 Emissions 6.1.1 Protection of radio services 6.1.1.1 *\u00a0Requirements <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 6.1.1.2 Tests <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 6.1.2 *\u00a0Protection of other equipment from low-frequency magnetic fields Protection of the public mains network 6.1.3.1 Harmonic distortion 6.1.3.1.1 *\u00a0Requirements 6.1.3.1.2 Tests 6.1.3.2 Voltage fluctuations and flicker 6.1.3.2.1 *\u00a0Requirements 6.1.3.2.2 Tests <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 6.2 Immunity 6.2.1 *\u00a0General 6.2.1.1 *\u00a0Immunity test levels 6.2.1.2 Documentation of the test 6.2.1.3 Operating mode and configuration 6.2.1.4 *\u00a0Electrical equipment that is not me\u00a0equipment <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 6.2.1.5 *\u00a0Patient-coupled me\u00a0equipment and me\u00a0systems 6.2.1.6 *\u00a0Variable gain 6.2.1.7 *\u00a0Patient simulation 6.2.1.8 *\u00a0Testing of normally non-observable functions <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 6.2.1.9 *\u00a0Subsystems 6.2.1.10 *\u00a0Compliance criteria 6.2.1.11 *\u00a0Me\u00a0equipment and me\u00a0systems that include radio equipment <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 6.2.2 Electrostatic discharge (ESD) 6.2.2.1 *\u00a0Requirements 6.2.2.2 Tests 6.2.3 Radiated RF electromagnetic fields 6.2.3.1 *\u00a0Requirements <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | 6.2.3.2 Tests <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | 6.2.4 Electrical fast transients and bursts 6.2.4.1 *\u00a0Requirements 6.2.4.2 Tests <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 6.2.5 Surges 6.2.5.1 *\u00a0Requirements 6.2.5.2 *\u00a0Tests <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 6.2.6 Conducted disturbances, induced by RF fields 6.2.6.1 *\u00a0Requirements <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 6.2.6.2 Tests <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | 6.2.7 Voltage dips, short interruptions and voltage variations on power supply input lines 6.2.7.1 *\u00a0Requirements <\/p>\n<\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 6.2.7.2 Tests 6.2.8 *\u00a0Magnetic fields 6.2.8.1 Power frequency magnetic fields 6.2.8.1.1 *\u00a0Requirements 6.2.8.1.2 Tests 6.2.8.2 *\u00a0Pulsed magnetic fields <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | 6.2.8.3 *\u00a0Damped oscillatory magnetic fields 6.2.9 *\u00a0Conducted disturbances in the range 0\u00a0Hz to 150\u00a0kHz 6.2.10 *\u00a0Oscillatory waves 6.2.11 *\u00a0Harmonics, interharmonics including mains signalling at a.c. power port 6.2.12 *\u00a0Ripple on d.c. power supply 6.2.13 *\u00a0Unbalance 6.2.14 Variations of power frequency <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests<\/b><\/p>\n |