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EMC Compliance
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.
Isolation Barriers
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 ANENPower supply, while the secondary isolation barrier is provided by another system component or ANENPOWER 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
Safety Approvals
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:
EU: EN60601-1:2006/A1:2013/A12:2014
USA: ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
Canada: CSA CAN/CSA-C22.2 No. 60601-1:14
From ANEN ENTERPRISE LIMITED
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