Edition EMC - PSMA

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IEC 60601-1-2Edition EMCth4Nicholas AbbondanteChief Engineer, EMC1www.intertek.com

OverviewWhat is it? What are the changes? When does it matter?Home use and Life Supporting, Special EnvironmentRisk ManagementProduct Configuration for Testing and Operating ModesMarking and Information to UserTest Voltages in 4th editionTesting – Emissions and Immunity, 3rd to 4th comparisonRadiated RF Immunity2www.intertek.com

What is it?IEC 60601-1-2 is a collateral standard to IEC 60601-1, which applies tothe BASIC SAFETY and ESSENTIAL PERFORMANCE of MedicalElectrical EQUIPMENT and Medical Electrical SYSTEMS in thepresence of ELECTROMAGNETIC DISTURBANCES and toELECTROMAGNETIC DISTURBANCES emitted by Medical ElectricalEQUIPMENT and Medical Electrical SYSTEMS.It applies to all medical electrical devices!3www.intertek.com

Why does EMC matter?July 29th, 1967 – USS Forrestal –134 Killed, 161 Injured21 aircraft destroyed, aircraftcarrier damaged ( 72 million; 509 million inflation adjusted)Surge caused Zuni missile to fire(but not detonate)Yes, there is a risk on aircraft 4www.intertek.com

Potential Medical Device EMC ProblemsSurgical Table actuates during surgeryCardiac Defibrillator activates unexpectedlyInfusion Pump changes rate of infusionECG or BP reading changes during surgeryVentilator stopsIncubator temperature incorrectPacemaker reprogrammedTonometer pokes patient in the eyeDevice gives incorrect information,- even useless!5www.intertek.com

FDA Medical Device EMC ProblemsCan search FDA ‘MAUDE’ database for records of EMC fdocs/cfMAUDE/search.CFMMany categories which are EMC relatedMany cases go unreported or are not identified as EMCEMC problems are sometimes difficult to reproduceEAS systems causing defibs, to R/C cars causing implants to beep6www.intertek.com

ME Equipment and SystemsMEDICAL ELECTRICAL EQUIPMENT “ME EQUIPMENT”electrical equipment having an applied part or transferring energy to or fromthe patient or detecting such energy transfer to or from the patient andwhich is:a) provided with not more than one connection to a particular supply mains;and b) intended by its manufacturer to be used:1) in the diagnosis, treatment, or monitoring of a patient; or2) for compensation or alleviation of disease, injury or disabilityMEDICAL ELECTRICAL SYSTEM “ME SYSTEM”combination, as specified by its manufacturer, of items of equipment, atleast one of which is ME EQUIPMENT to be inter-connected by functionalconnection or by use of a Multiple Socket-Outlet7www.intertek.com

Historical EditionsIEC 60601-1-2:2007 3rd EditionIEC 60601-1-2:2001 A1:2004 2nd EditionCENELEC EN 60601-1-2:2007 (with AC:2010)CENELEC EN 60601-1-2:2001 A1:20063rd edition harmonized in EU under Medical Device Directive,can be used for USA, 2nd edition no longer used withoutadditional explanation2nd edition still used in Japan, Brazil, some other countries8www.intertek.com

60601-2-X Particular Standards60601-1-2 is modified by Particular Standards that apply tocertain product typesCheck the scope of the particular standard to see if it appliesSome contain modifications to the EMC requirements. Clausenumbering varies from standard to standard.If a particular standard was written for a previous edition, itshould still be considered when testing to newer editions,even though the clause numbering is different.Also appearing under ISO 80601-2-XX and IEC 80601-2-XX9www.intertek.com

60601-2-X Particular Standards (from 08/2012)Particular StandardDescriptionIEC 60601-2-1 ed3.0 (2009-10)Electron Accelerators 1-50 MevIEC 60601-2-2 ed5.0 (2009-02)HF Surgical EquipmentIEC 60601-2-3 ed3.0 (2012-04)Short-wave Therapy EquipmentIEC 60601-2-4 ed3.0 (2010-12)Cardiac DefibrillatorsIEC 60601-2-5 ed3.0 (2009-07)Ultrasonic Physiotherapy EquipmentIEC 60601-2-6 ed2.0 (2012-04)Microwave Therapy EquipmentIEC 60601-2-7 ed2.0 (1998-02)X-ray GeneratorsIEC 60601-2-8 ed2.0 (2010-11)Therapeutic X-ray 10kV to 1 MVIEC 60601-2-10 ed2.0 (2012-06)IEC 60601-2-11 ed2.0 (1997-08) am1 (2004-07)ISO 80601-2-12 ed1.0 (2011-04)Nerve and Muscle StimulatorsGamma Beam Therapy EquipmentCritical Care VentilatorsISO 80601-2-13 ed1.0 (2011-08)Anaesthetic SystemsIEC 60601-2-16 ed4.0 (2012-03)Haemodialysis EquipmentIEC 60601-2-17 ed2.0 (2004-01)Brachytherapy Afterloading EquipmentIEC 60601-2-18 ed3.0 (2009-08)Endoscopic EquipmentIEC 60601-2-19 ed2.0 (2009-02)Infant IncubatorsIEC 60601-2-20 ed2.0 (2009-02)Infant Transport IncubatorsIEC 60601-2-21 ed2.0 (2009-02)Infant Radiant WarmersIEC 60601-2-22 ed3.0 (2007-05)Laser EquipmentIEC 60601-2-23 ed3.0 (2011-02)Transcutaneous Partial Pressure MonitoringIEC 60601-2-24 ed1.0 (1998-02)Infusion Pumps and ControllersIEC 60601-2-25 ed2.0 (2011-10)ElectrocardiographsIEC 60601-2-26 ed3.0 (2012-05)ElectroencephalographsIEC 60601-2-27 ed3.0 (2011-03)Electrocardiographic Monitoring Equipment10www.intertek.com

60601-2-X Particular Standards (from 08/2012)IEC 60601-2-28 ed2.0 (2010-03)X-ray Tube AssembliesIEC 60601-2-29 ed3.0 (2008-06)Radiotherapy SimulatorsIEC 80601-2-30 ed1.0 (2009-01)Automated Non-Invasive SphygmomanometersIEC 60601-2-31 ed2.1 (2011-09)External Cardiac Pacemakers internally poweredIEC 60601-2-32 ed1.0 (1994-03)Associated Equipment to X-ray SystemsIEC 60601-2-33 ed3.0 (2010-03)MR EquipmentIEC 60601-2-34 ed3.0 (2011-05)IBP Monitoring EquipmentIEC 80601-2-35 ed2.0 (2009-10)Blankets, Pads and Matresses, Intended for Heating in Medical UseIEC 60601-2-36 ed1.0 (1997-03)Extracorporeally Induced LithotripsyIEC 60601-2-37 ed2.0 (2007-08)Ultrasonic Medical Diagnostic and MonitoringIEC 60601-2-39 ed2.0 (2007-11)Peritoneal Dialysis EquipmentIEC 60601-2-40 ed1.0 (1998-02)Electromyographs and Evoked Response SystemsIEC 60601-2-41 ed2.0 (2009-08)Surgical LuminairesIEC 60601-2-43 ed2.0 (2010-03)X-ray for Interventional ProceduresIEC 60601-2-44 ed3.0 (2009-02)X-ray for CTIEC 60601-2-45 ed3.0 (2011-02)X-ray for Mammomagraphic Steriotactic DevicesIEC 60601-2-46 ed2.0 (2010-12)Operating TablesIEC 60601-2-47 ed2.0 (2012-02)Ambulatory ECG SystemsIEC 60601-2-49 ed2.0 (2011-02)Multifunction Patient Monitoring EquipmentIEC 60601-2-50 ed2.0 (2009-03)Infant Phototherapy EquipmentIEC 60601-2-52 ed1.0 (2009-12)Medical BedsIEC 60601-2-54 ed1.0 (2009-06)X-ray for Radiography and RadioscopyISO 80601-2-55 ed1.0 (2011-12)Respiratory Gas MonitorsISO 80601-2-56 ed1.0 (2009-10)Clinical Thermometers for Body Temperature MeasurementIEC 60601-2-57 ed1.0 (2011-01)Non-laser Light Source EquipmentISO 80601-2-61 ed1.0 (2011-04)Pulse Oximeters11www.intertek.com

What are the differences?Removal of the “Life-Supporting” device categoryIntroduction of the “Home Healthcare”, “ProfessionalHealthcare Facility”, and “Special” environmentsReformatting the immunity test requirements into tables byport to align with other immunity standardsIncreased test levels for various immunity testsIncreased immunity test levels to take into account radiodevices used in close proximity and guidance ondetermination of immunity levels in the “Special”environmentGuidance on adjustment of immunity test levels, determiningimmunity pass/fail criteria, and risk management12www.intertek.com

When does it matter?Date of Withdrawal of EN 60601-1-2:2007 3rdEdition: December 31st, 2018FDA is currently accepting and prefers 4th edition;4th edition will be required after April 1, 2017.All versions including 4th edition operative underCB Scheme, but only certain versions acceptedby specific CB Scheme members Austria, Belgium, France, Germany, HungarySingapore, Spain, Sweden, Switzerland, and USAhave NCBs who are accepting 4th edition13www.intertek.com

Life-Supporting ME EquipmentLIFE-SUPPORTING ME EQUIPMENT or ME SYSTEMME EQUIPMENT or ME SYSTEM that includes at least oneFUNCTION that is intended to actively keep alive orresuscitate PATIENTS and the failure of which to comply withthe requirements of 6.2.1.10 is likely to lead to serious injuryor death of a PATIENT14www.intertek.com

Professional Healthcare Facility EnvironmentPROFESSIONAL ME EQUIPMENT or ME SYSTEMME EQUIPMENT or ME SYSTEM for use by healthcareprofessionals and that is not intended for sale to the generalpublic (3rd edition)Examples (4th edition): Physician offices, dental offices, clinics,limited care facilities, freestanding surgical centers,freestanding birthing centers, multiple treatment facilities,hospitals (emergency rooms, patient rooms, intensive care,surgery rooms except near HF SURGICAL EQUIPMENT,outside the RF shielded room of an ME SYSTEM formagnetic resonance imaging)15www.intertek.com

Home Healthcare EnvironmentHOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11)dwelling place in which a PATIENT lives or other places wherePATIENTS are present, excluding professional healthcarefacility environments where OPERATORS with medicaltraining are continually available when PATIENTS arepresentExamples: Restaurants, cafes, shops, stores, markets,schools, churches, libraries, outdoors (streets, sidewalks,parks), domiciles (residences, homes, nursing homes),vehicles (cars, buses, trains, boats, planes, helicopters), trainstations, bus stations, airports, hotels, hostels, pensions,museums, theatres16www.intertek.com

Special EnvironmentSPECIAL ENVIRONMENTELECTROMAGNETIC ENVIRONMENT with electromagneticcharacteristics different from those specified in this collateral standardin Table 2 through Table 9 or that requires EMISSIONS limits,IMMUNITY TEST LEVELS or test methods that are different from thosespecified for the professional healthcare facility environment and theHOME HEALTHCARE ENVIRONMENTMilitary areas (submarines, near radar installations, near weaponscontrol systems), heavy industrial areas (power plants, steel and papermills, foundries, automotive and appliance manufacturing, smelting andmining operations, oil and gas refineries), medical treatment areas withhigh-powered ME EQUIPMENT (HF SURGICAL EQUIPMENT,SHORT-WAVE THERAPY EQUIPMENT, inside the RF shielded roomof an ME SYSTEM for magnetic resonance imaging)17www.intertek.com

Risk ManagementRISKS resulting from reasonably foreseeableELECTROMAGNETIC DISTURBANCES shall be taken intoaccount in the RISK MANAGEMENT PROCESS. Specific, detailed immunity pass/fail criteria based on part twostandards or risk management for basic safety and essentialperformance related to EMC Determination of how the product will be monitored todemonstrate compliance with the Immunity pass/fail criteria Immunity pass/fail criteria may specify degradations that areacceptable because they do not result in unacceptable risk Justification for any special increased or reduced test levelsRisk Management Guidance: Annex FTest Plan Guidance: Annex G18www.intertek.com

Operating ModesEmissions Testing Modes that maximize emissions Active and standby modes should be consideredImmunity Testing Modes and settings most likely to result in unacceptablerisk, as determined by the manufacturer via risk analysis,experience, engineering analysis, or pretesting Standby mode should be considered Devices not rated for continuous use can use a duty cycleDocumented in Test Plan and Test Report19www.intertek.com

Product Configuration for Testing Representative configuration consistent with intended use Most likely to result in unacceptable risk Determined by the manufacturer using risk analysis, experience,engineering analysis, or pretesting All cables, tubing, and fluid containers necessary for the intended usemust be attached and full, including system grounds when present Terminated with the intended equipment or by an appropriate simulator Artificial hand circuit (220pF 510Ω) attached to all handheld andpatient coupled parts, consistent with intended use AC Line Conducted Emissions, Electrical Fast Transients, and ConductedRF Immunity Special hardware or software may be required20www.intertek.com

Permanently Installed SystemsApproaches to testing Tested on a test site as a system Tested on a test site on a subsystem basis Test in situGroup 1 devices may meet the emissions limits specified for atest site when tested in situSome permanently installed systems are exempt from fullRadiated RF Immunity testing, testing with walkie-talkies,cellphones, RFID, and ISM bands in situ21www.intertek.com

MarkingsA warning is required for devices specified for use in a shieldedlocation stating this factThe intentional radiator mark has been removedThe ESD mark has been removed22www.intertek.com

Information to UserInstructions for Use Intended environment and exclusions for that environment Essential performance and user expectation during loss of performance Portable RF communications equipment safe distance warning Class A device warningTechnical Description Compliance for each EMC test, all deviations, and all necessaryinstructions for maintaining basic safety and essential performance forthe expected service life Frequency of operation, modulation, radiated power Additional statements for shielded rooms, large systems, and HF surgicalcompatibility23www.intertek.com

Test AC Voltage and Power FrequencyTest3rd Edition4th EditionAC Emissions,Cispr 11NominalAnyRadiated Emissions,Cispr 11NominalAnyHarmonics,IEC 61000-3-2230V/50Hz (sometimes100V/50Hz and100V/60Hz) or ratedvoltageRated single voltageor 230V forSingle-phase400V for 3-phase,50 or 60 HzVoltage Fluctuationsand Flicker,IEC 61000-3-3230V/50Hz or ratedvoltageRated single voltageor 230V forSingle-phase400V for 3-phase,50 or 60 Hz24www.intertek.com

Test AC Voltage and Power FrequencyTest3rd Edition4th EditionElectrostaticDischarge,IEC 61000-4-2AnyAnyRadiated RFImmunity,IEC 61000-4-3AnyAnyElectrical FastTransients/Burst,IEC 61000-4-4Lowest and HighestRated Voltage, anyfrequencyAnySurge, IEC 61000-4-5Lowest and HighestRated Voltage, anyfrequencyAny25www.intertek.com

Test AC Voltage and Power FrequencyTest3rd Edition4th EditionConducted RFImmunity,IEC 61000-4-6AnyAnyPower FrequencyMagnetics,IEC 61000-4-8Any Voltage, 50 and60 HzAny Voltage, either 50 or60 HzVoltage Dips,Dropouts, andInterruptions,IEC 61000-4-11Min and Max RatedVoltage, MinimumPower FrequencyIf rated voltage range 25% of lowest ratedvoltage, any one voltage.Otherwise, lowest andhighest rated voltage26www.intertek.com

A Note about Voltages Regulators can supersede the standard!Notable examples:Korea – 220V/60HzJapan – 100V/50Hz and 100V/60HzBrazil – 127V/60Hz and 220V/60Hz27www.intertek.com

Testing, Emissions –Professional Medical EquipmentRadiated and Conducted RF Emissions – Cispr 11 Shielded locations: increase Cispr limit based on shielding effectiveness X-rays in intermittent mode can increase quasi-peak limits by 20 dB Professional Medical Equipment can meet Class A or B Type A Medical Professional Devices – removed!Simple Electrical components (Motors, drills, switches) – Cispr 14 Only standalone devices – systems must meet Cispr 11Lighting Equipment – Cispr 15 – Removed!Multimedia Equipment – Cispr 32Exempt from IEC 61000-3-2 Harmonics and IEC 61000-3-3 Flickerunless it is intended to be connected to a publics mains network28www.intertek.com

Testing, Emissions –Home Healthcare DevicesRadiated and Conducted RF Emissions – Cispr 11 Equipment intended for use in aircraft ISO 7137 RTCA DO-160 EUROCAE ED-14 Equipment intended for automotive use Cispr 25 ISO 7637-2 Other standards may apply based on environmentHarmonics per IEC 61000-3-2, Flicker per IEC 61000-3-3 220V, 16A only Japan: 100V/50Hz and 100V/60Hz, 16A29www.intertek.com

Immunity TestingIEC 61000-4-2 Electrostatic DischargeIEC 61000-4-3 Radiated RF ImmunityIEC 61000-4-4 Electrical Fast Transients/BurstsIEC 61000-4-5 SurgeIEC 61000-4-6 Conducted RF ImmunityIEC 61000-4-8 MagneticsIEC 61000-4-11 Voltage Dips and InterruptionsISO 7637-2 Electrical Transient Conduction Along Supply Lines (DC)Emergency Medical Services devices classified as home healthcareDevices used in aircraft or other environments should meet additionalstandards such as RTCA DO-160G, ISO 7637-2, etc30www.intertek.com

Electrostatic Discharge, IEC 61000-4-2Test3rd Edition4th EditionContact Discharges 2, 4, 6 kV 2, 4, 8 kVAir Discharges 2, 4, 8 kV 2, 4, 8, 15 kVDischarges are applied to the patient coupling port with noconnection to artificial hand or patient simulation; devicechecked afterwards for pass/failOn I/O ports, contact discharges are applied to the connectorshell, and for insulated connector shells, air discharges areapplied only to the shell and any pins which can be contactedor touched31www.intertek.com

Radiated RF Immunity, IEC 61000-4-3Test3rd Edition4th EditionEnclosure 3V/m, Life Support: 10V/m 3V/m, Home: 10V/m80% AM at 1 kHz or 2 Hz80% AM at 1 kHz or risk frequency80 MHz – 2500 MHz80 MHz – 2700 MHzTest voltage is before modulation is appliedDwell time is based on the settling time of the test system and theadequate time for the device under test to be exercised and be affectedExclusion band for RF receivers applies, but basic safety and essentialperformance must be maintainedProximity fields from RF wireless communications equipment and specialenvironments must be considered32www.intertek.com

Radiated RF Immunity, IEC 61000-4-3RF Wireless Communications EquipmentMaxTestModulation Power Level(W)(V/m)Test(MHz)Band(MHz)Service385380 – 390TETRA 400Pulse 18 Hz1.827450430 – 470GMRS 460, FRS 460FM 5 kHz1 kHz sine228704 – 787LTE Band 13, 17Pulse217 Hz0.29800 – 960GSM 800/900; TETRA 800;iDEN 820; CDMA 850; LTEBand 5Pulse 18 Hz22871074578081087093033www.intertek.com

Radiated RF Immunity, IEC 61000-4-3RF Wireless Communications EquipmentTest(MHz)17201845Service1700 –1990GSM 1800; CDMA 1900;GSM 1900; DECT; LTEBand 1, 3, 4, 25; UMTSPulse217 Hz2282400 –2570Bluetooth; WLAN;802.11b/g/n; RFID 2450;LTE Band 7Pulse217 Hz2285100 –5800WLAN 802.11a/nPulse217 Hz0.291970245052405500MaxTestModulation Power Level(W)(V/m)Band(MHz)578534www.intertek.com

Radiated RF Immunity, IEC 61000-4-3RF Wireless Communications EquipmentNot all radio services are included. Risk Management should determinewhich services are applicable to a particular device.Automotive and Aircraft standards can include higher levelsTo declare closer distances than 30cm, testing at higher levels is requiredusing2 Watt radiated power P converted to 10 cm distance d gives E 84 V/m35www.intertek.com

Electrical Fast Transients/Bursts, IEC 61000-4-4Test3rd Edition4th EditionAC Mains or DC Input 2kV, 5 kHz PRF 2 kV, 100 kHz PRFI/O Ports 1 kV, 5 kHz PRF 1 kV, 100 kHz PRFArtificial hand attached to all handheld and patient coupledparts, consistent with intended useCables less than 3m in length are exempt36www.intertek.com

Surges, IEC 61000-4-5Test3rd Edition4th EditionAC Mains,Line to Ground 0.5, 1, 2 kV 0.5, 1, 2 kVAC Mains,Line to Line 0.5, 1 kV 0.5, 1 kVDC Input ( 3m),Line to GroundNo test 0.5, 1, 2 kVDC Input ( 3m),Line to LineNo test 0.5, 1 kVI/O, Line to GroundNo test 2 kV (outdoor linesonly)The option to test only at 0º, 90º, 270º, or 90º, 180º, 270º phase angleswas not carried over to the 4th edition!37www.intertek.com

Conducted RF Immunity, IEC 61000-4-6Test3rd Edition4th EditionAC Mains 3V, Life Support: 10V ISM 3V with 6V ISM, Home: 6V Amateur1 kHz or 2 Hz 80% AM80% AM at 1 kHz or risk frequency150 kHz – 80 MHz150 kHz – 80 MHzDC & I/O& PatientCoupled( 3m)3V, Life Support: 10V ISM 3V with 6V ISM, Home: 6V Amateur1 kHz or 2 Hz 80% AM80% AM at 1 kHz or risk frequency150 kHz – 80 MHz150 kHz – 80 MHzRMS voltage, before modulation is applied. FDA has not accepted 3m exclusionArtificial hand attached to all handheld and patient coupled parts, consistent withintended usePatient tubes intentionally filled with a conductive liquid are patient coupled cables38www.intertek.com

Power Frequency Magnetics, IEC 61000-4-8Test3rd Edition4th EditionEnclosure3 A/m, 50 and 60 Hz30 A/m, 50 or 60 HzTested in X, Y, and Z axesCan be waived due to a justification that there are no magneticcomponentsAssumes a minimum distance of 15 cm to magnetic source in actualusage39www.intertek.com

Voltage Dips, Dropouts, and Interruptions,IEC 61000-4-11Test3rd Edition4th EditionVoltage Dips ( 16A) 95% dip, 0.5 periods,0º and 180º100% drop, 0.5 periods,0º, 45º, 90º, 135º, 180º,225º, 270º, 315º100% dip, 1 period30% dip, 25/30 periods60% dip, 5 periods30% dip, 25 periodsVoltage Interruptions 95% drop, 5 seconds 100% drop, 5 seconds(all input current)Voltage interruptions shall be applied to all phasessimultaneouslySystems intended for use with an AC to DC converter shall betested with a converter which meets the manufacturer’sspecification40www.intertek.com

Conclusions4th edition compliance is not required yet, but will be by the endof a 2-3 year development cycleRetesting is necessary as many requirements have beenincreasedTesting for 4th edition is not completely backwards compatiblewith 3rd editionIt is important to consider EMC during the risk managementprocess and to make sure that the EMC testing addressesbasic safety and all identified risks41www.intertek.com

Resources on EMC and 4th EditionRight click on the IMAGE and select “open link” to access:Learn Market TrendsBased on Intertek’sRecent Experience withFDA and 4th Edition“Testing Wireless Devices forEMC”, Medical Design BriefsOr visit our website atwww.intertek.com/4thEditionfor the latest information42thTop 4 Edition FAQs“Address Security & EMC Compliancein Your Connected Device”, MedicalDevice Technologywww.intertek.com

QuestionsValued Quality. Delivered.43www.intertek.com

Apr 01, 2017 · IEC 60601-1-2:2007 3rd Edition IEC 60601-1-2:2001 A1:2004 2nd Edition CENELEC EN 60601-1-2:2007 (with AC:2010) CENELEC EN 60601-1-2:2001 A1:2006 3rd edition harmonized in EU under Medical Device Directive, can be used for USA, 2nd edition no longer used without additional explanation 2nd edition still used in Japan, Brazil, some other countries

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