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