Electrical Equipment In Medical Practice

Electrical Equipment inMedical PracticeSteve HayesGeneral Manager

IEC 60601-1-2:2014 -What‘s new?“Electromagnetic Compatibility”replaced to be in line withphilosophy of IEC 60601-1

IEC 60601-Series of Standards: StructureIEC 60601-1 Medical Electrical EquipmentPart 1: General requirements for basic safety and essential performanceIEC 60601-1-XCollateral Standards(for classes ofproducts)IEC 60601-2-XParticular Standards(for specific products)-1-2: Electromagnetic Compatibility-1-3: Radiation Protection-1-6: Usability-1-8: Alarms-1-9: Environment-1-10: Physiological Closed-Loop Controllers-1-11: Home Healthcare Environment-1-12: Emergency Medical Services EnvironmentPart 2: Particular requirements for basic safety and essentialperformance of about 70 product familiese.g. CT, MR, endoscopic-, ultrasonic equipmentProducts need to apply:a) the -1b) all applicable Collateral’sc) all applicable Particular’swhich all have to belong tothe same edition of the -1

Risk ManagementRiskAnalysisRiskEvaluation Intended useandidentificationof safetyrelating tomedicaldevice Hazard ID Estimation ofrisk for eachhazard IDRisk AssessmentRiskControl Risk controloption analysis Implementationof the controlmeasures Residual riskevaluation Risk/benefitanalysis Risks arisingfrom the controlmeasures Completenessof the riskcontrolRiskEvaluation ofthe overallresidual riskacceptabilityRisk ManagementRiskManagementreportProduction& postproductioninformation

Function of IEC 60601-1-2 in the Risk Management ProcessIEC 60601-1:Basic Safety and Essential PerformanceIEC 60601-1-2EMC test methodsEMC design techniques(for hardware and software)Mitigation Methods- Bonding- Filtering- Shielding- Galvanic isolation- OvervoltageProtection- etc.Risk ManagementEM Risk analysisShock risksEM Risk evaluationFire risksEM Risk controlMechanical risksRisks caused byelectromagneticdisturbancesRisks caused byclimatic conditionsRisks from misuseEtc.Risk Management FileElectromagneticenvironmentsIEC 60601-1-2ISO 14971Using verification andvalidation methods such as:- Demonstrations- Checklists- Inspections- Reviews & assessments- Independent reviews andassessments- Audits- Non-standardized checksand tests- individual and/or integratedhardware tests- Computer simulation- EM testingEM Risk acceptabilityEM Risk management reportEM Production and post-productioninformation

Example of risk controlGapLimitHarmonised Standard150kHz125kHz

Electromagnetic Safety v Compatibility

What is Basic Safety v Essential Performance?BASIC SAFETYESSENTIAL PERFORMANCEfreedom from unacceptable RISKdirectly caused by physical HAZARDSwhen ME EQUIPMENT is used underNORMAL CONDITION and SINGLE FAULTperformance necessary to achieve freedom fromunacceptable RISKCONDITIONNOTE ESSENTIAL PERFORMANCE is most easily understood byconsidering whether its absence or degradationwould result in an unacceptable RISK.

EM Basic Safety v Essential Performance230v

An example – medical diagnostic PC Core i74k graphicsBTLEEthernetWiFi

What environment has it designed for?

Wireless Medical ProductsRadio Equipment DirectiveEmissionsImmunityMedical Devices DirectivesArticle 3.1(a)safetyArticle 3.1(b)EMCArticle 3.2 radioN/AEN 301 489 - xEN 303 446 - xETSI EN radiostandard(s)EN 60601-1-2Clause 7RiskAssessmentEN 301 489-xEN 303 446 - xN/AEN 60601-1-2Clause 8

Medical v Radio EMC StandardsBasic Test StandardIEC 60601-1-2:2014 ed. 4EN 301 489-xIEC/EN 61000-4-2:2009 – Electrostatic Discharge ImmunityxxIEC/EN 61000-4-3:2006 A1:2008 A2:2010 – Radiated RF ImmunityxxIEC/EN 61000-4-4:2012 – Electrical Fast Transients ImmunityxxIEC/EN 61000-4-5:2014 – Voltage Surge ImmunityxxIEC/EN 61000-4-6:2014 – Conducted RF ImmunityxxEN 61000-4-8:2010 – Power Frequency Magnetic Field ImmunityxxEN 61000-4-11:2004 – Voltage Dips and Short Interruptions ImmunityISO 7637-2:2011 – Voltage Transients and Surges for Equipment used in a vehicularenvironmentxxxxEN 55011:2009 A1:2010 – Radiated EmissionsxxEN 55011:2009 A1:2010 – Conducted EmissionsxxRTCA/DO160G Section 21 Category M – Conducted and Radiated Emissions forEquipment used in an aircraft environmentEN 61000-3-2:2014 – Harmonic Current EmissionsxxEN 61000-3-3:2013 – Voltage Fluctuations and Flickerxxx

Changes from Edition 3 to Edition 4 (II) (Examples) 3 environmental categories with corresponding phenomena and test levels are defined:a.HOME HEALTHCARE ENVIRONMENTb.Professional healthcare facility environmentsc.Special (specification of test levels based on process in Annex E) Test levels represent the reasonably foreseeable maximum level of ELECTROMAGNETICDISTURBANCES in the environments of INTENDED USE for category a. and b. Definition of a process which allows for special environments to adopt the specific testlevel (Annex E)

Special Environments

Emissions ComparisonLevelsIndustrial CommercialMore stringentlimits withwiderfrequencyrangeDomestic CommercialAircraft – Categories B-LFrequency

LevelsSusceptibility ComparisonAircraft – Categories B-L Aircraft – Categories cted)DomesticCommercial(conducted)More severelimits withwiderfrequencyrangeIndustrial Commercial(radiated)Domestic Commercial(radiated)Frequency

Radiated Immunity – Wireless Comms Freq’sTest Frequency (MHz)385ModulationPulse Modulation18 HzTest Level (V/m)27450FM 5 kHz Deviation, 1 kHz sine wave28710Pulse Modulation 217 Hz9745Pulse Modulation 217 Hz9780Pulse Modulation 217 Hz9810Pulse Modulation 18 Hz28870Pulse Modulation 18 Hz28930Pulse Modulation 18 Hz281720Pulse Modulation 217 Hz281845Pulse Modulation 217 Hz281970Pulse Modulation 217 Hz282450Pulse Modulation 217 Hz285240Pulse Modulation 217 Hz95500Pulse Modulation 217 Hz95785Pulse Modulation 217 Hz9

Changes from Edition 3 to Edition 4 (III) (Examples) Test levels are higher for some phenomena: ESD Conducted disturbances induced by RF fields (HAM radio -, ISM - bands) RATED power frequency magnetic fields(It is not so easy to compare it to edition 3 because other compliance criteria (basic safety andessential performance) are valid!) Considers new phenomena Immunity against RF transmitters in close proximity (mobile phones, WiFi,RFID, etc.) Considers modulation characteristics Test procedure according IEC 61000-4-3 as interim solution till specificprocedure is developed by SC77B(planned IEC 61000-4-39).

Changes from Edition 3 to Edition 4 (IV) (Examples) Describes procedures to continue testing, if EUT reacts (chapt. 8.1). “Standby mode” should be considered Attachment of POTENTIAL EQUALIZATION CONDUCTOR and of all tubing and filling of all fluidcontainers Requirements for minimum contents of test reports Is in line with requirements from IEC 60601-1 according to “EXPECTED SERVICE LIFE” AC input voltage requirements clarified for all tests

Compliance CheckClarifies the tasks of EMC testlaboratories

“EMC-Requirements” (in the sense of Performance)?“ELECTROMAGNETIC COMPATIBILITY(EMC performance)”, was removed fromFDIS of IEC 60601-1-2 is as separateTechnical Report (TR)(IEC 60601-4-2 was published in 2016).

IEC 60601-1-2 edition 4 – Time Schedule2014-02date of publication2014-06FDA recognized with exceptions2019-02end of stability periodEurope2015-022018-12DOP of EN 60601-1-2:2015DOC of EN 60601-1-2:2015(EN61601-1-2:2007 can be used until this date)

Thank you for yourattention!

Analysis Risk control option analysis Implementation of the control measures Residual risk . ISO 14971 Risk Management Shock risks Fire risks Mechanical risks Risks caused by electromagnetic disturbances . Gap Harmonised Standard Limit 150kHz.