Complying Standards - REAC RCB15 User Manual

7 Complying Standards

Complying Standards
Hoist Specific ISO 10535:2006
Electrical Safety IEC 60601-1:2006 and amendment
1:2012
IEC 60601-1-11:2015
IEC 60601-1-2:2014
Electromagnetic CISPR 11 Class B (2009)
Emission
IEC 61000-3-2 (2014)
IEC 61000-3-3 (2013)
Electromagnetic IEC 61000-4-2 (2008)
Immunity
IEC 61000-4-3 (2006 + A1 + A2)
IEC 60601-1-2:2014
Description
Hoists for the transfer of disabled persons –
Requirements and test methods
Applicable parts
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance.
Medical electrical equipment – Part 1-11:
General requirements for basic safety and
essential performance – Collateral Standard:
Requirements for medical electrical equipment
and medical electrical systems used in the
home healthcare environment.
Medical electrical equipment – Part 1-2:
General requirements for basic safety and
essential performance – Collateral Standard:
Electromagnetic disturbances – Requirements
and tests.
Radiated and conducted emission
Harmonic current emission
Voltage fluctuations and flicker
Immunity to electrostatic discharge
Test levels:
±8 kV contact discharge ±2, ±4, ±8 and ±15 kV
air discharge
Immunity to radiated electromagnetic fields in
the frequency range 80 – 1000 MHz and 1,0 –
2, 7GHz
Test levels:
80 – 1000 MHz 10 V/m with 80 % AM @ 2 Hz
1,0 – 2,7 GHz 10 V/m with 80 % AM @ 2 Hz.
Table 9 (up to 28 V/m pulse modulation at
frequencies in ISM bands)
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