TruSat Technical Reference Manual
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1.5 Compliance
European Union Medical Device Directive 93/42/EEC: Class IIb
EN 60601-1 Medical electrical equipment – Part 1: General requirements for safety
(including Amendments 1 and 2)
• Type of protection against electric shock: Class I equipment/Internal electrical
power source
• Degree of protection against electric shock: Defibrillation-proof type BF applied
part
• Degree of protection against ingress of water (EN 60529): IPX2
• Not suitable for use in the presence of flammable anesthetic mixtures
• Mode of operation: Continuous
EN 60601-1-2 (2
nd
Edition) Electromagnetic compatibility – Requirements and tests For
details, see Electromagnetic compatibility (EMC) later in this section.
CISPR 11/EN 55011 (Protection against emissions): Group I, Class B
IEC 60601-1-8 Alarm systems – General requirements, tests and guidance for alarm
systems in medical electrical equipment and systems
Medical electrical equipment classified in the US and Canada with respect
to electric shock, fire, and mechanical hazards only, in accordance with
the Canadian Standards Association CAN/CSA C22.2 No. 601.1 and
Underwriters Laboratories Inc. UL 2601–1.
Related standards and tests
Standard Description
EN 60601-1, clause 21 Rigidity, strength, handle loading drop test
EN 60601-1, clause 42 Temperature
EN 60601-1, clause 48 Non-toxic materials used for surface of case
EN 60601-1, sub-clause 59.2(b) Resistance of case to heat and fire
EN 865, clause 44 Overflow, spillage, ingress of liquids, cleaning
and disinfection
IEC 61000-3-2 Harmonic emissions
IEC 61000-3-3 Voltage fluctuations and flicker emissions
IEC 61000-4-2, level 3 Electrostatic discharge immunity
IEC 61000-4-3, level 2 Radiated RF electromagnetic field immunity
IEC 61000-4-4, level 3 Electrical fast transient and burst immunity
IEC 61000-4-5, level 3 Surge immunity
IEC 61000-4-6 Susceptibility to conducted EMI
IEC 61000-4-8 Power frequency magnetic fields
IEC 61000-4-11, Table 7 Operation during line voltage variations
IEC 60068-2-32 Operation during physical shock/drop and
repetitive drop
UL 2601-1, clause 55 Impact test
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