Compliance; Related Standards And Tests - GE TruSat Technical Reference Manual

TruSat Technical Reference Manual

1.5 Compliance

Related standards and tests

1–8
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
nd
EN 60601-1-2 (2 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.
Standard
EN 60601-1, clause 21
EN 60601-1, clause 42
EN 60601-1, clause 48
EN 60601-1, sub-clause 59.2(b)
EN 865, clause 44
IEC 61000-3-2
IEC 61000-3-3
IEC 61000-4-2, level 3
IEC 61000-4-3, level 2
IEC 61000-4-4, level 3
IEC 61000-4-5, level 3
IEC 61000-4-6
IEC 61000-4-8
IEC 61000-4-11, Table 7
IEC 60068-2-32
UL 2601-1, clause 55
Description
Rigidity, strength, handle loading drop test
Temperature
Non-toxic materials used for surface of case
Resistance of case to heat and fire
Overflow, spillage, ingress of liquids, cleaning
and disinfection
Harmonic emissions
Voltage fluctuations and flicker emissions
Electrostatic discharge immunity
Radiated RF electromagnetic field immunity
Electrical fast transient and burst immunity
Surge immunity
Susceptibility to conducted EMI
Power frequency magnetic fields
Operation during line voltage variations
Operation during physical shock/drop and
repetitive drop
Impact test