IEC 60601-1-2 4 th Edition EMC Nicholas Abbondante Chief Engineer, - - PowerPoint PPT Presentation
IEC 60601-1-2 4 th Edition EMC Nicholas Abbondante Chief Engineer, EMC 1 www.intertek.com Overview What is it? What are the changes? When does it matter? Home use and Life Supporting, Special Environment Risk Management Product
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Nicholas Abbondante Chief Engineer, EMC
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Overview
What is it? What are the changes? When does it matter? Home use and Life Supporting, Special Environment Risk Management Product Configuration for Testing and Operating Modes Marking and Information to User Test Voltages in 4th edition Testing – Emissions and Immunity, 3rd to 4th comparison Radiated RF Immunity
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What is it?
IEC 60601-1-2 is a collateral standard to IEC 60601-1, which applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of Medical Electrical EQUIPMENT and Medical Electrical SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by Medical Electrical EQUIPMENT and Medical Electrical SYSTEMS. It applies to all medical electrical devices!
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Why does EMC matter?
July 29th, 1967 – USS Forrestal – 134 Killed, 161 Injured 21 aircraft destroyed, aircraft carrier damaged ($72 million; $509 million inflation adjusted) Surge caused Zuni missile to fire (but not detonate) Yes, there is a risk on aircraft…
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Potential Medical Device EMC Problems
Surgical Table actuates during surgery Cardiac Defibrillator activates unexpectedly Infusion Pump changes rate of infusion ECG or BP reading changes during surgery Ventilator stops Incubator temperature incorrect Pacemaker reprogrammed Tonometer pokes patient in the eye Device gives incorrect information,
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FDA Medical Device EMC Problems
Can search FDA ‘MAUDE’ database for records of EMC issues http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM Many categories which are EMC related Many cases go unreported or are not identified as EMC EMC problems are sometimes difficult to reproduce EAS systems causing defibs, to R/C cars causing implants to beep
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ME Equipment and Systems
MEDICAL ELECTRICAL EQUIPMENT “ME EQUIPMENT” electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which 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; or 2) for compensation or alleviation of disease, injury or disability MEDICAL ELECTRICAL SYSTEM “ME SYSTEM” combination, as specified by its manufacturer, of items of equipment, at least one of which is ME EQUIPMENT to be inter-connected by functional connection or by use of a Multiple Socket-Outlet
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Historical Editions
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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60601-2-X Particular Standards
60601-1-2 is modified by Particular Standards that apply to certain product types Check the scope of the particular standard to see if it applies Some contain modifications to the EMC requirements. Clause numbering varies from standard to standard. If a particular standard was written for a previous edition, it should 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-XX
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60601-2-X Particular Standards (from 08/2012)
Particular Standard Description IEC 60601-2-1 ed3.0 (2009-10) Electron Accelerators 1-50 Mev IEC 60601-2-2 ed5.0 (2009-02) HF Surgical Equipment IEC 60601-2-3 ed3.0 (2012-04) Short-wave Therapy Equipment IEC 60601-2-4 ed3.0 (2010-12) Cardiac Defibrillators IEC 60601-2-5 ed3.0 (2009-07) Ultrasonic Physiotherapy Equipment IEC 60601-2-6 ed2.0 (2012-04) Microwave Therapy Equipment IEC 60601-2-7 ed2.0 (1998-02) X-ray Generators IEC 60601-2-8 ed2.0 (2010-11) Therapeutic X-ray 10kV to 1 MV IEC 60601-2-10 ed2.0 (2012-06) Nerve and Muscle Stimulators IEC 60601-2-11 ed2.0 (1997-08) +am1 (2004-07) Gamma Beam Therapy Equipment ISO 80601-2-12 ed1.0 (2011-04) Critical Care Ventilators ISO 80601-2-13 ed1.0 (2011-08) Anaesthetic Systems IEC 60601-2-16 ed4.0 (2012-03) Haemodialysis Equipment IEC 60601-2-17 ed2.0 (2004-01) Brachytherapy Afterloading Equipment IEC 60601-2-18 ed3.0 (2009-08) Endoscopic Equipment IEC 60601-2-19 ed2.0 (2009-02) Infant Incubators IEC 60601-2-20 ed2.0 (2009-02) Infant Transport Incubators IEC 60601-2-21 ed2.0 (2009-02) Infant Radiant Warmers IEC 60601-2-22 ed3.0 (2007-05) Laser Equipment IEC 60601-2-23 ed3.0 (2011-02) Transcutaneous Partial Pressure Monitoring IEC 60601-2-24 ed1.0 (1998-02) Infusion Pumps and Controllers IEC 60601-2-25 ed2.0 (2011-10) Electrocardiographs IEC 60601-2-26 ed3.0 (2012-05) Electroencephalographs IEC 60601-2-27 ed3.0 (2011-03) Electrocardiographic Monitoring Equipment
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60601-2-X Particular Standards (from 08/2012)
IEC 60601-2-28 ed2.0 (2010-03) X-ray Tube Assemblies IEC 60601-2-29 ed3.0 (2008-06) Radiotherapy Simulators IEC 80601-2-30 ed1.0 (2009-01) Automated Non-Invasive Sphygmomanometers IEC 60601-2-31 ed2.1 (2011-09) External Cardiac Pacemakers internally powered IEC 60601-2-32 ed1.0 (1994-03) Associated Equipment to X-ray Systems IEC 60601-2-33 ed3.0 (2010-03) MR Equipment IEC 60601-2-34 ed3.0 (2011-05) IBP Monitoring Equipment IEC 80601-2-35 ed2.0 (2009-10) Blankets, Pads and Matresses, Intended for Heating in Medical Use IEC 60601-2-36 ed1.0 (1997-03) Extracorporeally Induced Lithotripsy IEC 60601-2-37 ed2.0 (2007-08) Ultrasonic Medical Diagnostic and Monitoring IEC 60601-2-39 ed2.0 (2007-11) Peritoneal Dialysis Equipment IEC 60601-2-40 ed1.0 (1998-02) Electromyographs and Evoked Response Systems IEC 60601-2-41 ed2.0 (2009-08) Surgical Luminaires IEC 60601-2-43 ed2.0 (2010-03) X-ray for Interventional Procedures IEC 60601-2-44 ed3.0 (2009-02) X-ray for CT IEC 60601-2-45 ed3.0 (2011-02) X-ray for Mammomagraphic Steriotactic Devices IEC 60601-2-46 ed2.0 (2010-12) Operating Tables IEC 60601-2-47 ed2.0 (2012-02) Ambulatory ECG Systems IEC 60601-2-49 ed2.0 (2011-02) Multifunction Patient Monitoring Equipment IEC 60601-2-50 ed2.0 (2009-03) Infant Phototherapy Equipment IEC 60601-2-52 ed1.0 (2009-12) Medical Beds IEC 60601-2-54 ed1.0 (2009-06) X-ray for Radiography and Radioscopy ISO 80601-2-55 ed1.0 (2011-12) Respiratory Gas Monitors ISO 80601-2-56 ed1.0 (2009-10) Clinical Thermometers for Body Temperature Measurement IEC 60601-2-57 ed1.0 (2011-01) Non-laser Light Source Equipment ISO 80601-2-61 ed1.0 (2011-04) Pulse Oximeters
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What are the differences?
Removal of the “Life-Supporting” device category Introduction of the “Home Healthcare”, “Professional Healthcare Facility”, and “Special” environments Reformatting the immunity test requirements into tables by port to align with other immunity standards Increased test levels for various immunity tests Increased immunity test levels to take into account radio devices used in close proximity and guidance on determination of immunity levels in the “Special” environment Guidance on adjustment of immunity test levels, determining immunity pass/fail criteria, and risk management
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When does it matter?
Date of Withdrawal of EN 60601-1-2:2007 3rd Edition: December 31st, 2018 FDA is currently accepting and prefers 4th edition; 4th edition will be required after April 1, 2017. All versions including 4th edition operative under CB Scheme, but only certain versions accepted by specific CB Scheme members
Singapore, Spain, Sweden, Switzerland, and USA have NCBs who are accepting 4th edition
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Life-Supporting ME Equipment
LIFE-SUPPORTING ME EQUIPMENT or ME SYSTEM ME EQUIPMENT or ME SYSTEM that includes at least one FUNCTION that is intended to actively keep alive or resuscitate PATIENTS and the failure of which to comply with the requirements of 6.2.1.10 is likely to lead to serious injury
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Professional Healthcare Facility Environment
PROFESSIONAL ME EQUIPMENT or ME SYSTEM ME EQUIPMENT or ME SYSTEM for use by healthcare professionals and that is not intended for sale to the general public (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,
magnetic resonance imaging)
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Home Healthcare Environment
HOME HEALTHCARE ENVIRONMENT (IEC 60601-1-11) dwelling place in which a PATIENT lives or other places where PATIENTS are present, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present Examples: Restaurants, cafes, shops, stores, markets, schools, churches, libraries, outdoors (streets, sidewalks, parks), domiciles (residences, homes, nursing homes), vehicles (cars, buses, trains, boats, planes, helicopters), train stations, bus stations, airports, hotels, hostels, pensions, museums, theatres
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Special Environment
SPECIAL ENVIRONMENT ELECTROMAGNETIC ENVIRONMENT with electromagnetic characteristics different from those specified in this collateral standard in Table 2 through Table 9 or that requires EMISSIONS limits, IMMUNITY TEST LEVELS or test methods that are different from those specified for the professional healthcare facility environment and the HOME HEALTHCARE ENVIRONMENT Military areas (submarines, near radar installations, near weapons control systems), heavy industrial areas (power plants, steel and paper mills, foundries, automotive and appliance manufacturing, smelting and mining operations, oil and gas refineries), medical treatment areas with high-powered ME EQUIPMENT (HF SURGICAL EQUIPMENT, SHORT-WAVE THERAPY EQUIPMENT, inside the RF shielded room
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Risk Management
RISKS resulting from reasonably foreseeable ELECTROMAGNETIC DISTURBANCES shall be taken into account in the RISK MANAGEMENT PROCESS.
standards or risk management for basic safety and essential performance related to EMC
demonstrate compliance with the Immunity pass/fail criteria
acceptable because they do not result in unacceptable risk
Risk Management Guidance: Annex F Test Plan Guidance: Annex G
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Operating Modes
Emissions Testing
Immunity Testing
risk, as determined by the manufacturer via risk analysis, experience, engineering analysis, or pretesting
Documented in Test Plan and Test Report
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Product Configuration for Testing
engineering analysis, or pretesting
must be attached and full, including system grounds when present
patient coupled parts, consistent with intended use
RF Immunity
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Permanently Installed Systems
Approaches to testing
Group 1 devices may meet the emissions limits specified for a test site when tested in situ Some permanently installed systems are exempt from full Radiated RF Immunity testing, testing with walkie-talkies, cellphones, RFID, and ISM bands in situ
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Markings
A warning is required for devices specified for use in a shielded location stating this fact The intentional radiator mark has been removed The ESD mark has been removed
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Information to User
Instructions for Use
Technical Description
instructions for maintaining basic safety and essential performance for the expected service life
compatibility
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Test AC Voltage and Power Frequency
Test 3rd Edition 4th Edition AC Emissions, Cispr 11 Nominal Any Radiated Emissions, Cispr 11 Nominal Any Harmonics, IEC 61000-3-2 230V/50Hz (sometimes 100V/50Hz and 100V/60Hz) or rated voltage Rated single voltage
Single-phase 400V for 3-phase, 50 or 60 Hz Voltage Fluctuations and Flicker, IEC 61000-3-3 230V/50Hz or rated voltage Rated single voltage
Single-phase 400V for 3-phase, 50 or 60 Hz
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Test AC Voltage and Power Frequency
Test 3rd Edition 4th Edition Electrostatic Discharge, IEC 61000-4-2 Any Any Radiated RF Immunity, IEC 61000-4-3 Any Any Electrical Fast Transients/Burst, IEC 61000-4-4 Lowest and Highest Rated Voltage, any frequency Any Surge, IEC 61000-4-5 Lowest and Highest Rated Voltage, any frequency Any
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Test AC Voltage and Power Frequency
Test 3rd Edition 4th Edition Conducted RF Immunity, IEC 61000-4-6 Any Any Power Frequency Magnetics, IEC 61000-4-8 Any Voltage, 50 and 60 Hz Any Voltage, either 50 or 60 Hz Voltage Dips, Dropouts, and Interruptions, IEC 61000-4-11 Min and Max Rated Voltage, Minimum Power Frequency If rated voltage range <25% of lowest rated voltage, any one voltage. Otherwise, lowest and highest rated voltage
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A Note about Voltages…
Regulators can supersede the standard! Notable examples: Korea – 220V/60Hz Japan – 100V/50Hz and 100V/60Hz Brazil – 127V/60Hz and 220V/60Hz
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Testing, Emissions – Professional Medical Equipment
Radiated and Conducted RF Emissions – Cispr 11
Simple Electrical components (Motors, drills, switches) – Cispr 14
Lighting Equipment – Cispr 15 – Removed! Multimedia Equipment – Cispr 32 Exempt from IEC 61000-3-2 Harmonics and IEC 61000-3-3 Flicker unless it is intended to be connected to a publics mains network
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Testing, Emissions – Home Healthcare Devices
Radiated and Conducted RF Emissions – Cispr 11
Harmonics per IEC 61000-3-2, Flicker per IEC 61000-3-3
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Immunity Testing
IEC 61000-4-2 Electrostatic Discharge IEC 61000-4-3 Radiated RF Immunity IEC 61000-4-4 Electrical Fast Transients/Bursts IEC 61000-4-5 Surge IEC 61000-4-6 Conducted RF Immunity IEC 61000-4-8 Magnetics IEC 61000-4-11 Voltage Dips and Interruptions ISO 7637-2 Electrical Transient Conduction Along Supply Lines (DC) Emergency Medical Services devices classified as home healthcare Devices used in aircraft or other environments should meet additional standards such as RTCA DO-160G, ISO 7637-2, etc
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Electrostatic Discharge, IEC 61000-4-2
Discharges are applied to the patient coupling port with no connection to artificial hand or patient simulation; device checked afterwards for pass/fail On I/O ports, contact discharges are applied to the connector shell, and for insulated connector shells, air discharges are applied only to the shell and any pins which can be contacted
Test 3rd Edition 4th Edition Contact Discharges ±2, 4, 6 kV ±2, 4, 8 kV Air Discharges ±2, 4, 8 kV ±2, 4, 8, 15 kV
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Radiated RF Immunity, IEC 61000-4-3
Test voltage is before modulation is applied Dwell time is based on the settling time of the test system and the adequate time for the device under test to be exercised and be affected Exclusion band for RF receivers applies, but basic safety and essential performance must be maintained Proximity fields from RF wireless communications equipment and special environments must be considered Test 3rd Edition 4th Edition Enclosure 3V/m, Life Support: 10V/m 80% AM at 1 kHz or 2 Hz 80 MHz – 2500 MHz 3V/m, Home: 10V/m 80% AM at 1 kHz or risk frequency 80 MHz – 2700 MHz
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Radiated RF Immunity, IEC 61000-4-3 RF Wireless Communications Equipment
Test (MHz) Band (MHz) Service Modulation Max Power (W) Test Level (V/m) 385 380 – 390 TETRA 400 Pulse 18 Hz 1.8 27 450 430 – 470 GMRS 460, FRS 460 FM ±5 kHz 1 kHz sine 2 28 710 704 – 787 LTE Band 13, 17 Pulse 217 Hz 0.2 9 745 780 810 800 – 960 GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE Band 5 Pulse 18 Hz 2 28 870 930
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Radiated RF Immunity, IEC 61000-4-3 RF Wireless Communications Equipment
Test (MHz) Band (MHz) Service Modulation Max Power (W) Test Level (V/m) 1720 1700 – 1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse 217 Hz 2 28 1845 1970 2450 2400 – 2570 Bluetooth; WLAN; 802.11b/g/n; RFID 2450; LTE Band 7 Pulse 217 Hz 2 28 5240 5100 – 5800 WLAN 802.11a/n Pulse 217 Hz 0.2 9 5500 5785
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Radiated RF Immunity, IEC 61000-4-3 RF Wireless Communications Equipment
Not all radio services are included. Risk Management should determine which services are applicable to a particular device. Automotive and Aircraft standards can include higher levels To declare closer distances than 30cm, testing at higher levels is required using 2 Watt radiated power P converted to 10 cm distance d gives E = 84 V/m
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Electrical Fast Transients/Bursts, IEC 61000-4-4
Artificial hand attached to all handheld and patient coupled parts, consistent with intended use Cables less than 3m in length are exempt Test 3rd Edition 4th Edition AC Mains or DC Input ±2kV, 5 kHz PRF ±2 kV, 100 kHz PRF I/O Ports ±1 kV, 5 kHz PRF ±1 kV, 100 kHz PRF
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Surges, IEC 61000-4-5
The option to test only at 0º, 90º, 270º, or 90º, 180º, 270º phase angles was not carried over to the 4th edition! Test 3rd Edition 4th Edition AC Mains, Line to Ground ±0.5, 1, 2 kV ±0.5, 1, 2 kV AC Mains, Line to Line ±0.5, 1 kV ±0.5, 1 kV DC Input (>3m), Line to Ground No test ±0.5, 1, 2 kV DC Input (>3m), Line to Line No test ±0.5, 1 kV I/O, Line to Ground No test ±2 kV (outdoor lines
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Conducted RF Immunity, IEC 61000-4-6
RMS voltage, before modulation is applied. FDA has not accepted 3m exclusion Artificial hand attached to all handheld and patient coupled parts, consistent with intended use Patient tubes intentionally filled with a conductive liquid are patient coupled cables Test 3rd Edition 4th Edition AC Mains 3V, Life Support: 10V ISM 1 kHz or 2 Hz 80% AM 150 kHz – 80 MHz 3V with 6V ISM, Home: 6V Amateur 80% AM at 1 kHz or risk frequency 150 kHz – 80 MHz DC & I/O & Patient Coupled (>3m) 3V, Life Support: 10V ISM 1 kHz or 2 Hz 80% AM 150 kHz – 80 MHz 3V with 6V ISM, Home: 6V Amateur 80% AM at 1 kHz or risk frequency 150 kHz – 80 MHz
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Power Frequency Magnetics, IEC 61000-4-8
Tested in X, Y, and Z axes Can be waived due to a justification that there are no magnetic components Assumes a minimum distance of 15 cm to magnetic source in actual usage Test 3rd Edition 4th Edition Enclosure 3 A/m, 50 and 60 Hz 30 A/m, 50 or 60 Hz
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Voltage Dips, Dropouts, and Interruptions, IEC 61000-4-11
Voltage interruptions shall be applied to all phases simultaneously Systems intended for use with an AC to DC converter shall be tested with a converter which meets the manufacturer’s specification Test 3rd Edition 4th Edition Voltage Dips (<16A) >95% dip, 0.5 periods, 0º and 180º 60% dip, 5 periods 30% dip, 25 periods 100% drop, 0.5 periods, 0º, 45º, 90º, 135º, 180º, 225º, 270º, 315º 100% dip, 1 period 30% dip, 25/30 periods Voltage Interruptions (all input current) >95% drop, 5 seconds 100% drop, 5 seconds
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Conclusions
4th edition compliance is not required yet, but will be by the end
Retesting is necessary as many requirements have been increased Testing for 4th edition is not completely backwards compatible with 3rd edition It is important to consider EMC during the risk management process and to make sure that the EMC testing addresses basic safety and all identified risks
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Questions?