IEC SC62A MT 23Liaison Report to C63® SC84 May 2011

Jeffrey L. SilberbergFDA/CDRH

C63 SC8 meeting 2011-05-04 Cedar Park, TX 2

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

C63 SC8 meeting 2011-05-04 Cedar Park, TX 3

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

C63 SC8 meeting 2011-05-04 Cedar Park, TX 4

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

C63 SC8 meeting 2011-05-04 Cedar Park, TX 5

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

C63 SC8 meeting 2011-05-04 Cedar Park, TX 6

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

C63 SC8 meeting 2011-05-04 Cedar Park, TX 7

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

C63 SC8 meeting 2011-05-04 Cedar Park, TX 8

Example test levels for Enclosure port

Phenomenon

Immunity test levels

Hospital Small clinic Home Transport

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)

C63 SC8 meeting 2011-05-04 Cedar Park, TX 9

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