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 Configuration for Testing and Operating Modes Marking and Information to User Test Voltages in 4 th edition Testing – Emissions and Immunity, 3 rd to 4 th comparison Radiated RF Immunity 2 www.intertek.com
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! 3 www.intertek.com
Why does EMC matter? July 29 th , 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… 4 www.intertek.com
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, - even useless! 5 www.intertek.com
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 6 www.intertek.com
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 7 www.intertek.com
Historical Editions IEC 60601-1-2:2007 3 rd Edition IEC 60601-1-2:2001+A1:2004 2 nd Edition CENELEC EN 60601-1-2:2007 (with AC:2010) CENELEC EN 60601-1-2:2001+A1:2006 3 rd edition harmonized in EU under Medical Device Directive, can be used for USA, 2 nd edition no longer used without additional explanation 2 nd edition still used in Japan, Brazil, some other countries 8 www.intertek.com
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 9 www.intertek.com
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 10 www.intertek.com
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 11 www.intertek.com
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 12 www.intertek.com
When does it matter? Date of Withdrawal of EN 60601-1-2:2007 3 rd Edition: December 31 st , 2018 FDA is currently accepting and prefers 4 th edition; 4 th edition will be required after April 1, 2017. All versions including 4 th edition operative under CB Scheme, but only certain versions accepted by specific CB Scheme members • Austria, Belgium, France, Germany, Hungary Singapore, Spain, Sweden, Switzerland, and USA have NCBs who are accepting 4 th edition 13 www.intertek.com
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 or death of a PATIENT 14 www.intertek.com
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 (3 rd edition) Examples (4 th 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 for magnetic resonance imaging) 15 www.intertek.com
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 16 www.intertek.com
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