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Accredited Standards Committee C63® - EMC
Subcommittee 8 Stephen Berger Chair
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Accredited Standards Committee C63® - EMC
Motions Motion: Approve initiation of the Invitation to Ballot process in parallel with conducting Subcommittee ballot for C The Mandatory Editorial Coordination (MEC) process will also be conducted in parallel with the Invitation to Ballot process to form the ballot group.
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Accredited Standards Committee C63® - EMC
Scope of Subcommittee 8 (unchanged from last meeting) Subcommittee 8 is responsible for writing and maintaining existing and proposed C63® standards for medical devices, as assigned by the Main Committee ASC 63®.
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Accredited Standards Committee C63® - EMC
Membership of Subcommittee 8 Changes since last meeting: 0 deletions from the membership due to inactivity. 0 addition to the membership. Total members – 14 (There are currently no medical device manufacturers, managers of healthcare facilities or healthcare delivery facilities in the membership of the subcommittee.) 4
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Accredited Standards Committee C63® - EMC
Membership of Subcommittee 8 Name Role Affiliation / Financial Support Andersen, Poul Member Poul Andersen Consulting / SAE Berger, Stephen Chair TEM Consulting Case, David CISCO DeLisi, Bob UL, LLC Griffin, Andy CISCO Systems Hare, Ed ARRL Heirman, Don Don HEIRMAN Consultants Hoolihan, Dan Hoolihan EMC Consulting Kuczynski, Victor Vican Electronics Liu, Steve PCTEST Engineering Laboratory, Inc. Moongilan, Dheena Nokia Silberberg, Jeffrey L FDA Center for Devices & Radiological Health Whitesell, Steve Vice Chair Whitesell Consulting Zimmerman, Dave Secretary Spectrum EMC Consulting 5
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Accredited Standards Committee C63® - EMC
Subcommittee 8 Duties SC8 Developed and Maintains the following Standards C 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 C American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
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Accredited Standards Committee C63® - EMC
C63.18 On-site immunity testing of medical equipment Document published: June 20, 2014
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Accredited Standards Committee C63® - EMC
WG-2 C63.19 Hearing Aid compatibility WG-2 has requested that the ballot group be formed so that the ballot process for the revision being worked on can be started.
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Accredited Standards Committee C63® - EMC
Motions A motion to request a waiver of paragraph of the ASC 63® procedures and to recommend to the main committee to move the draft standard C63.19 directly to the balloting process.
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