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Whitepapers from Euorfins York

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IEC : EN 60601-1-2 Implications of 4th the Edition

This whitepaper from York EMC Services details the increased stringency of the latest IEC/EN 60601-1 and IEC/EN 60601-1-2 standards for medical electrical (ME) equipment EMC testing. The core change involves a shift towards risk management; manufacturers must now submit a detailed Risk Management File (RMF) outlining potential EMC phenomena, justification of test levels, operating modes, and separation distances prior to formal compliance testing. Radiated immunity tests are harmonized up to 2.7 GHz, while conducted immunity sees increased levels in ISM/amateur bands (6V). Specific immunity level increases include ESD to ±8kV contact and ±15kV air discharge, and magnetic field immunity to 30 A/m. The paper highlights the need for proactive risk assessment to determine appropriate testing parameters including RF wireless communication proximity fields with minimum separation distances defined within the RMF.

Medical Device EMC

Problems That Can Arise in a Working EMC Laboratory and How Pre Test Verifications Can Help

This white paper from Eurofins York EMC Services, authored by Dave Cullen and Mark Anslow, examines the practical challenges that can compromise measurement quality in a working EMC test laboratory and makes the case for systematic pre-test verification. The paper identifies four main categories of risk: equipment failure (including physical damage to RF connectors, electrical damage from transients, and performance degradation through normal ageing), inconsistency and repeatability issues arising from reconfigured test chambers or changing environmental conditions, equipment operating outside its calibration specification in ways that standard recalibration may not catch, and human error from incorrect settings, procedural gaps, or outdated test standard implementations. Each problem is illustrated with real examples, such as a faulty mains power supply introducing voltage oscillations larger than the flicker disturbance being measured, contaminated connectors at an Open Area Test Site causing rippled frequency responses, and a receiver exhibiting stepped anomalies of up to 4 dB that fell within the manufacturer's published specification. The paper then outlines how pre-test verification using reference signal sources can detect these issues before they affect results. It compares broadband noise sources, which provide continuous spectral coverage and are effective at revealing frequency-dependent faults and verifying detector and bandwidth settings, against comb (harmonic) generators, which offer discrete frequency components useful for checking frequency and amplitude accuracy. The conclusion is that a layered approach combining robust procedures, trained personnel, and regular pre-test checks against a stable reference baseline is essential for maintaining confidence in EMC test results.

EMI/EMC IntroductionEMC Pre Compliance

Tackling The Issue of Non Compliant Products With A New EMC Directive

This paper examines conformity levels with the EMC Directive in Europe, based on analysis of six cross-border market surveillance campaigns conducted between 2004 and 2014, focusing on products like energy saving lamps, LED lighting, and solar panel inverters. The study found consistently low compliance rates; notably, only 33% of 55 sampled solar panel inverters met emission requirements as defined by the 2004/108/EC directive, while overall administrative compliance was at 38%. Despite high CE Marking prevalence (95%), a significant portion lacked correct documentation (Declaration of Conformity: 56% compliant; Technical Documentation: 63% compliant). The authors highlight that reported compliance figures are optimistic due to incomplete testing and assumptions about untested parameters like immunity. They conclude the actual compliance rate is likely far below the reported 9%, potentially even zero, indicating widespread non-compliance and unfair competition within the European market.

EMI/EMC Introduction