IEC SC62A MT 23
®
Liaison Report to C63 SC8
4 May 2011
Jeffrey L. Silberberg
FDA/CDRH
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
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
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
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Changes made from previous draft
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
Performance (EMC) requirements were
moved to an informative annex
Several of the proposed new test methods
were deleted
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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
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Changes made from previous draft (cont’d)

Several requirements were deleted


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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
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Changes made from previous draft (cont’d)

Some general immunity test levels were
lowered
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
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
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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
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Changes made from previous draft (cont’d)

An MT23 member is writing proposals for
SC77A for circulation as an NWIP
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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
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Example test levels for Enclosure port
Immunity test levels
Phenomenon
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
C63 SC8 meeting 2011-05-04 Cedar Park, TX
c)
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MT23 Next steps
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Finish (revising) responses to 460 comments
from first CD
Respond to 217 comments on questionnaire
(62A/700/Q)
MT23 meeting scheduled for August 2011
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To respond to comments on 62A/746/CD and
prepare CDV
Probably in White Oak / Silver Spring, MD
Goal for CDV: November 2011
C63 SC8 meeting 2011-05-04 Cedar Park, TX
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