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IEC SC62A MT 23 Liaison Report to C63 ® SC8 4 May 2011 Jeffrey L. Silberberg FDA/CDRH.

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Presentation on theme: "IEC SC62A MT 23 Liaison Report to C63 ® SC8 4 May 2011 Jeffrey L. Silberberg FDA/CDRH."— Presentation transcript:

1 IEC SC62A MT 23 Liaison Report to C63 ® SC8 4 May 2011 Jeffrey L. Silberberg FDA/CDRH

2 C63 SC8 meeting 2011-05-04 Cedar Park, TX2 IEC SC62A MT23 Liaison Report MT23 met February 2011 in Carlsbad, CA  Prepared second CD of IEC 60601-1-2 Ed. 4 for circulation IEC 60601-1-2 Ed. 4 circulated 2011-03-04 as 62A/746/CD  Comment period closes 2011-06-10  US SC62A TAG meeting 2011-05-13 to prepare US comments

3 C63 SC8 meeting 2011-05-04 Cedar Park, TX3 Changes made from previous draft Performance (EMC) requirements were moved to an informative annex Several of the proposed new test methods were deleted  Low-frequency magnetic field emissions  Low-frequency magnetic field immunity*  Close-distance RF immunity* * Under consideration

4 C63 SC8 meeting 2011-05-04 Cedar Park, TX4 Changes made from previous draft (cont’d) Several requirements were deleted  Harmonics and flicker emissions for equipment rated at > 16 A  Harmonics and interharmonics immunity Patient cable conducted emissions test is now informative Deleted requirements and published standards listed as things that should be considered in the Risk Management process

5 C63 SC8 meeting 2011-05-04 Cedar Park, TX5 Changes made from previous draft (cont’d) Some general immunity test levels were lowered  Radiated RF  Home and Transport ESD Higher immunity test levels in frequency bands where sources are  ISM  Amateur radio  Portable communications equipment

6 C63 SC8 meeting 2011-05-04 Cedar Park, TX6 Changes made from previous draft (cont’d) The close distance RF test was replaced with an interim test using IEC 61000-4-3 at 30 V/m to approximate portable transmitters  Recommended separation distances, but smaller distances  Warning symbol required if you don’t do the test

7 C63 SC8 meeting 2011-05-04 Cedar Park, TX7 Changes made from previous draft (cont’d) An MT23 member is writing proposals for SC77A for circulation as an NWIP  Proximity RF immunity  Proximity magnetic field immunity Normative references are now dated unless there is a reason otherwise PORT is now a defined term, figure “Clinic” environment renamed to “Small clinic”  Categories: Hospital, Small clinic, Home, Transport, Special

8 C63 SC8 meeting 2011-05-04 Cedar Park, TX8 Example test levels for Enclosure port Phenomenon Immunity test levels HospitalSmall clinicHomeTransport Electrostatic discharge ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air EM Field a) 3 V/m f) g) 80 MHz – 1000 MHz, 1,4 GHz - 2,7 GHz and 5 GHz – 6 GHz b) 80% AM @ 1 kHz c) 3 V/m f) g) 80 MHz – 1000 MHz, 1,4 GHz - 2,7 GHz and 5 GHz – 6 GHz b) 80% AM @ 1 kHz c) 10 V/m f) 80 MHz – 1000 MHz b) 3 V/m 1,4 GHz - 2,7 GHz and 5 GHz – 6 GHz 80% AM @ 1 kHz c) 20 V/m f) 80 MHz – 1000 MHz b) 10 V/m f) 1,4 GHz - 2,7 GHz 3 V/m f) 5 GHz – 6 GHz) 80% AM @ 1 kHz c)

9 C63 SC8 meeting 2011-05-04 Cedar Park, TX9 MT23 Next steps Finish (revising) responses to 460 comments from first CD Respond to 217 comments on questionnaire (62A/700/Q) MT23 meeting scheduled for August 2011  To respond to comments on 62A/746/CD and prepare CDV  Probably in White Oak / Silver Spring, MD  Goal for CDV: November 2011


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