IEC Second Edition

Transcription

1 Electromagnetic Compatibility of Medical Electrical Equipment Second Edition Prepared by Mr. James Conrad Presented by Dr. William A. Radasky 1 Second Edition Updates first edition on standards developed since 1992 Uses the series of basic EMC standards Responds to feedback from users on what was good and what was lacking in the first edition Clarifies compliance requirements 2

2 Second Edition Emissions Requirements Uses CISPR 11 as requirement for systems and most stand alone devices Allows CISPR 14 and 15 for some devices with restrictions Allows use of CISPR 22 equipment in CISPR 11 systems without additional testing 3 Second Edition Emission - Continued Addresses intentional transmitters, statistical testing, large equipment Requires application of and

3 Second Edition Immunity Requirements Requirements based upon concept of essential performance - not just safety Gives greater detail on testing and requirements - addresses simulation Adds why information in rationale for part two standards writers and users Excludes non-medical equipment which can not adversely affect patient outcome 5 Second Edition Immunity - Continued : 8 kv air and 6 kv contact : 80 MHz to 2.5 GHz 3 V/m for non-life supporting and 10 V/m for life supporting equipment , -6: 2 Hz or 1 khz 6

4 Second Edition Immunity - Continued : 2 kv for power and 1 kv for I/O - patient leads are not tested : 2 kv line(s) to ground and 1 kv line(s) to lines(s) : 3 V 150 khz to 80 MHz; 10V in the ISM bands for life supporting devices : 3 A/m, 50/60 Hz 7 Second Edition Immunity - Continued : Dips 0.5 period, >95% dip; 5 periods, 60% dip; 25 periods, 30% dip equipment <1 kw maintains essential performance equipment >1 kw safe, no failures, restorable : Interruptions 5 seconds, >95% drop remains safe, no failures, restorable 8

5 Compliance criteria The following are not permitted if associated with essential performance component failures changes in programmable parameters reset to factory defaults change of operating mode false alarms 9 Compliance criteria (continued) cessation of any intended operation, even if accompanied by an alarm initiation of any unintended operation, including unintended or uncontrolled motion, even if accompanied by an alarm 10

6 Compliance criteria (continued) error of a displayed numerical value sufficiently large to affect diagnosis, therapy, or treatment noise on a waveform which is indistinguishable from physiologically-produced signals or interferes with interpretation of physiologically-produced signals 11 Compliance criteria (continued) artifact or distortion in an image which interferes with interpretation of physiologically-produced signals failure of automatic diagnosis or treatment EQUIPMENT to diagnose or treat, even if accompanied by an alarm 12

7 Second Edition Accompanying Documents Requires disclosure of device performance for emissions and immunity The user has the responsibility to ensure the device is used within the intended EMC environment Responsibilities for third party accessories 13 Guidance and Manufacturer s Declaration Electromagnetic Emissions: The Model 001 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 001 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions Group 1 Class B Class A The Model 001 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Model 001 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/ flicker emissions Complies 14

8 Summary Basic Standard ITE EN55024, Electrostatic Discharge ±3 kvc ±8 kva ±6 kvc ±8 kva ±4 kvc ±8 kva RF EMF Immunity V/m 26 MHz MHz 3/10 V/m 80 MHz- 2.5 GHz 3 V/m 80 MHz- 1.0 GHz 15 Summary - continued Basic Standard ITE EN55024, Fast Transients kv Power Lines 0.5 kv I/O Lines 2 kv Power Lines 1 kv I/O Lines 1 kv Power Lines 0.5 kv I/O Lines Surges kvdiff 2 kvcom (AC Lines Only) 1 kvdiff 2 kvcom (AC Lines Only) 0.5 kvac Lines 0.5 kvdc Lines 1 kvi/o Lines 16

9 Summary - continued ITE Basic EN55024, Standard Conducted RF Immunity none 3/10 V 150 khz 80 MHz 3 V 150 khz 80 MHz Magnetic Field none 3 A/m 50/60 Hz 1 A/m 50/60 Hz 17 Summary - continued ITE Basic EN55024, Standard Voltage dips and short interruptions none <5% Un -.5 s 40% Un - 5 s 70% Un- 25 s <5% Un-.5 s 70% Un-25 s <5% Un - 5 s 18

10 Summary Status Published - September 2001 EN Published - D.O.W. 1 November 2004 US ANSI/AAMI Adopted Future 1 st Amendment out for voting 2 nd Amendment to cover immunity levels for Home, Transport, and Aircraft environments. 19