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BS EN 60601-1-2:2007:2010 Edition

BS EN 60601-1-2:2007:2010 Edition

$215.11

Medical electrical equipment – General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests

Published By Publication Date Number of Pages
BSI 2010 128
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PDF Catalog

PDF Pages PDF Title
11 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
13 3 Terms and definitions
16 4 General requirements
4.1 General requirements for electromagnetic compatibility of me equipment and me systems
4.1.1 * Electromagnetic compatibility
17 4.1.2 Electrical equipment that is not me equipment
4.2 * Single fault condition for me equipment
5 Identification, marking and documents
5.1 Marking on the outside of me equipment or me equipment parts
5.1.1 * Marking on the outside of me equipment or me equipment parts that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment
5.1.2 Marking on the outside of me equipment or me equipment parts for which the connector testing exemption specified in 6.2.2.2 c) is used
5.1.3 Marking on the outside of me equipment and me systems that are specified for use only in a shielded location
18 5.2 Accompanying documents
5.2.1 Instructions for use
5.2.1.1 Requirements applicable to all me equipment and me systems
5.2.1.2 Requirements applicable to me equipment and me systems for which the connector testing exemption specified in 6.2.2.2 c) is used
5.2.1.3 Minimum amplitude or value of patient physiological signal
5.2.1.4 * Requirements applicable to type a professional me equipment and me systems
19 5.2.2 Technical description
5.2.2.1 Requirements applicable to all me equipment and me systems
27 5.2.2.2 * Requirements applicable to me equipment and me systems other than those specified for use only in a shielded location
34 5.2.2.3 Requirements applicable to me equipment and me systems specified for use only in a shielded location
35 5.2.2.4 Requirements applicable to me equipment and me systems that intentionally apply RF energy for diagnosis or treatment
36 5.2.2.5 Requirements applicable to me equipment and me systems that intentionally receive RF electromagnetic energy for the purpose of their operation
5.2.2.6 Requirements applicable to me equipment and me systems that include RF transmitters
38 5.2.2.7 * Requirements applicable to cables, transducers and other accessories that could affect compliance with the requirements of 6.1 and 6.2
39 5.2.2.8 Requirements applicable to large, permanently-installed me equipment and me systems
5.2.2.9 Requirements applicable to me equipment and me systems found to have no essential performance
5.2.2.10 * Requirements applicable to type a professional me equipment and me systems
40 6 Electromagnetic compatibility
6.1 Emissions
6.1.1 Protection of radio services
6.1.1.1 * Requirements
41 6.1.1.2 Tests
42 6.1.2 * Protection 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 * Requirements
6.1.3.1.2 Tests
6.1.3.2 Voltage fluctuations and flicker
6.1.3.2.1 * Requirements
6.1.3.2.2 Tests
43 6.2 Immunity
6.2.1 * General
6.2.1.1 * Immunity test levels
6.2.1.2 Documentation of the test
6.2.1.3 Operating mode and configuration
6.2.1.4 * Electrical equipment that is not me equipment
44 6.2.1.5 * Patient-coupled me equipment and me systems
6.2.1.6 * Variable gain
6.2.1.7 * Patient simulation
6.2.1.8 * Testing of normally non-observable functions
45 6.2.1.9 * Subsystems
6.2.1.10 * Compliance criteria
6.2.1.11 * Me equipment and me systems that include radio equipment
46 6.2.2 Electrostatic discharge (ESD)
6.2.2.1 * Requirements
6.2.2.2 Tests
6.2.3 Radiated RF electromagnetic fields
6.2.3.1 * Requirements
47 6.2.3.2 Tests
49 6.2.4 Electrical fast transients and bursts
6.2.4.1 * Requirements
6.2.4.2 Tests
51 6.2.5 Surges
6.2.5.1 * Requirements
6.2.5.2 * Tests
52 6.2.6 Conducted disturbances, induced by RF fields
6.2.6.1 * Requirements
53 6.2.6.2 Tests
56 6.2.7 Voltage dips, short interruptions and voltage variations on power supply input lines
6.2.7.1 * Requirements

57 6.2.7.2 Tests
6.2.8 * Magnetic fields
6.2.8.1 Power frequency magnetic fields
6.2.8.1.1 * Requirements
6.2.8.1.2 Tests
6.2.8.2 * Pulsed magnetic fields
58 6.2.8.3 * Damped oscillatory magnetic fields
6.2.9 * Conducted disturbances in the range 0 Hz to 150 kHz
6.2.10 * Oscillatory waves
6.2.11 * Harmonics, interharmonics including mains signalling at a.c. power port
6.2.12 * Ripple on d.c. power supply
6.2.13 * Unbalance
6.2.14 Variations of power frequency

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BS EN 60601-1-2:2007
$215.11