IEC SC62A MT 23 Liaison Report to C63

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IEC SC62A MT 23Liaison Report to C63 SC84 May
2011

• Jeffrey L. Silberberg
• FDA/CDRH

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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

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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

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Changes made from previous draft (contd)

• Several requirements were deleted
• Harmonics and flicker emissions for equipment
  rated at gt 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

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Changes made from previous draft (contd)

• 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

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Changes made from previous draft (contd)

• 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 dont do the test

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Changes made from previous draft (contd)

• 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

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Example test levels for Enclosure port
Phenomenon Immunity test levels Immunity test levels Immunity test levels 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 _at_ 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 _at_ 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 _at_ 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 _at_ 1 kHz c)
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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