Medical Industry Understanding
Our products undergo EMC testing to help us provide as much information as possible during design-in to ensure compliance with IEC60601-1-2. To aid compliance, EMC testing facilities within Europe and North America are available free of charge to customers.
Laboratory Environment Compliance
For equipment used within laboratory environments, compliance with IEC60950 is normally sufficient, involving less stringent isolation and leakage current requirements.
The diagram below illustrates isolation for a typical medical device with an applied part. Two isolation barriers are required to ensure that the applied part is isolated from the ground and meets the patient leakage current limits during normal and single fault conditions. The primary isolation barrier for this type of equipment can be provided by an XP Power supply, while the secondary isolation barrier is provided by another system component or XP solution.
Emission and Immunity Specifications
IEC55011/IEC55022 Limits for conducted and radiated emissions
IEC61000-3-2 Limits for harmonic current emissions
IEC61000-3-3 Limitation of voltage changes,voltage variations and flicker
IEC61000-4-2 Electrostatic discharge immunity
IEC61000-4-3 Radiated immunity
IEC61000-4-4 Electrical fast transient immunity
IEC61000-4-5 Electrical surge immunity
IEC61000-4-6 Conducted disturbance immunity
IEC61000-4-8 Immunity to power frequency magnetic field
IEC61000-4-11 Immunity to voltage dips, short interruptions and variations on supply line
The latest version of 60601-1 is the 3rd edition which was first published in December 2005. the standard has been adopted in the major countries/regions of the world and published as the following versions:
USA: ANSI/AAMI ES 60601-1:2005 Ed. 2
Canada: CSA-C22.2 NO. 60601-1:08
Isolation and Seperation - IEC60601-1:2005
Insulation test voltages based on 250 VAC working voltage.
MOP = Means of Protection.
MOOP = Means of operation protection.
MOPP = Means of patient protection
Earth leakage = Current flowing in the earth conductor
Enclosure leakage = Current flowing to earth via the patient from the enclosure.
Patient leakage = Current flowing to earth via the patient from an applied part.
Patient auxiliary = Current flowing between two applied parts
NC = Normal Conditions SFC = Single Fault conditions
*Patient care equipment maximum earth and enclosure leakage current for the US is 300 μA
Figures quoted are for portable equipment.