Transcript Accredited Standards Committee C63 ® - EMC

Accredited Standards Committee
C63® - EMC
Subcommittee 8
Bob DeLisi / Stephen Berger
Chair / Vice-Chair
2014-11-11
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Accredited Standards Committee
C63® - EMC
Motions
No Motions requested from SC8
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Accredited Standards Committee
C63® - EMC
Membership of Subcommittee 8
No additions or deletions from the membership
Total members - 22
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Accredited Standards Committee
C63® - EMC
Duties of Subcommittee 8
C63.18 - American National Recommended
Practice for an On-Site, Ad Hoc Test Method for
Estimating Electromagnetic Immunity of Medical
Devices to Radiated Radio-Frequency (RF)
Emissions from RF Transmitters
C63.19 - American National Standard
Methods of Measurement of
Compatibility between Wireless
Communications Devices and
Hearing Aids
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Accredited Standards Committee
C63® - EMC
WG -1 C63.18 On-site immunity testing of medical
equipment
Document published: June 20, 2014
Thanks to Jeff Silberberg for all his efforts to get this document published.
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Accredited Standards Committee
C63® - EMC
WG-2 C63.19 Hearing Aid compatibility
• WG-2 Chair reported that the leading consumer group Hearing Loss
Association of America, HLAA, is doing an annual survey on HAC
satisfaction.
• Results have been negative.
• Both C63 and TIA have published standards the FCC recognizes for HAC
• TIA – Landline phones
• C63 – Mobile phones
• Hearing Industries Association, HIA, has gotten involved
• HIA has reached out to WG-2 Chair for assistance in trying to figure out
what the issues are.
• At this time no action is required by C63 but C63.19 may need to change in
the future to address the issues once they are uncovered.
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Accredited Standards Committee
C63® - EMC
Subcommittee 8 Working Group Status
Since all work in C63.18 and C63.19 is completed these working goups are
disbanded until new work times are needed.
HAC information will be provide as a Liaison report until such a time that
work is needed by C63 Subcommittee 8.
No New Work requests have been made to the Subcommittee.
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Accredited Standards Committee
C63® - EMC
Liaison Reports
• FDA Report (Summary of on-going work at the FDA)
• Currently participating on the following working groups; C63.12,
C63.16 and C63.27
• Continued work with the Association for Automatic Identification and
Mobility (AIM Global) RFID Experts Group (REG) to draft and validate
protocols for testing immunity of medical devices to RFID systems
• Working on IEC 61000-4-39: Radiated fields in close proximity
immunity test (77B/717/CD) which was removed from IEC 60601-1-2.
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Accredited Standards Committee
C63® - EMC
Liaison Reports
• FDA Report (Summary of on-going work at the FDA)
• IEC 60601-1-2:2014
• FDA has recognized IEC and AAMI versions of 60601-1-2:2014
(4th edition). Recognition was Mid 2014.
• Transition from IEC 60601-1-2:2007 (3rd Edition) to IEC 60601-12:2014 by mid April 1, 2017
• FDA has adopted the standard in full except Table 8, 61000-4-6
row, exemption of I/O cables < 3 m long
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Accredited Standards Committee
C63® - EMC
Liaison Reports
• FDA Report (Summary of on-going work at the FDA)
• AAMI activities within the FDA include
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Co-chair of wireless coexistence TIR working group
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Co-chair of working group – EMC test protocols for cardiac
rhythm management
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Working on EMC section of a standard for cochlear implants
•
Specifications for Humidity in the operating room (for equipment)
• ISO activities within the FDA
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Working on the second edition of ISO/TS 10974, Assessment of
the safety of magnetic resonance imaging for patients with an
active implantable medical device
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Accredited Standards Committee
C63® - EMC
Liaison Reports
• FDA Report (Summary of on-going work at the FDA)
• Released Final Guidance: Design Considerations for Devices
Intended for Home Use Announced on August 5, 2014
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Harmonized with IEC 60601-1-11
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References ANSI/AAMI/IEC 60601-1-2:2014 for EMC
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Will be revised with immunity test levels that are recommended for
use with 60601-1-2:2007
• FDA involvement with Wireless Coexistence
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Continued work on C63.27 as well as working with AAMI and OU
Tulsa
• Ongoing meetings with FCC and SAE on wireless chargers for
automobiles.
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Accredited Standards Committee
C63® - EMC
Liaison Reports
• IEC SC62A MT 23
•IEC 60601-1-2 4th Edition
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Amendment 1 already in progress since publication of 4th
edition.
•IEC/TR 60601-4-2: Medical electrical equipment – Part 4-2:
Guidance and interpretation – Electromagnetic immunity;
performance of medical electrical equipment and medical
electrical systems
• Circulated on October 24 as 62A/971/CD
•IEC 61000-4-39: Electromagnetic compatibility (EMC) – Part 4-39:
Testing and measurement techniques – Radiated fields in close
proximity immunity test (77B/717/CD)
• Comments were due 10-10-2014
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Accredited Standards Committee
C63® - EMC
Liaison Reports
• AAMI
• AAMI TIR18 Ed. 2 - Publication 2013: References C63.18
• Used by clinical and biomedical engineers
• AAMI has also recognized the 4th edition of IEC 60601-12:2014
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