Philips Respironics V60 - Appendix D. Regulatory compliance; Electromagnetic compatibility (EMC)

1047358 Rev N Respironics V60 Ventilator User Manual D-1
Appendix D. Regulatory compliance
Electromagnetic
compatibility (EMC)
2nd edition standards
3rd edition standards
EN 60601-1-2 Electromagnetic Compatibility Requirements and Tests
EN 55011 Radiated and Conducted RF Disturbance Characteristics--Limits
and Methods of Measurement (Level A)
EN 55014-1 Electromagnetic Compatibility Requirements. Part 1: Emissions
EN 61000-3-2 Limits for Harmonic Current Emissions
EN 61000-3-3 Limitation of Voltage Changes, Fluctuations, and Flicker Emissions
EN 61000-4-2 Electrostatic Discharge Immunity Test (8/15KV)
EN 61000-4-3 Radiated Electromagnetic Field Immunity Test (10V/M)
EN 61000-4-4 Electrical Fast Transient/Burst Immunity Test
EN 61000-4-5 Surge Immunity Test
EN 61000-4-6 Immunity to Conducted RF Disturbances (10V)
EN 61000-4-8 Power Frequency Magnetic Field Immunity Test
EN 61000-4-11 Voltage Dips, Short Interruptions, and Voltage Variations Immunity
Tests
MIL-STD 461E
RE101
Electromagnetic Field Generation (Army Level)
IEC 60601-1;
Ed. 3.1
Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
IEC 60601-1-2;
Ed. 3.0
Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances
IEC 60601-1-6;
2013
Medical electrical equipment – Part 1-6: General requirements for
safety
IEC 60601-1-8;
Ed. 2.1
Medical electrical equipment – Part 1-8: General requirements for
safety
IEC 62366; 2007 +
A1: 2004
Medical devices - Application of usability engineering to medical
devices