1. Accredited Standards Committee C63® - EMC
Subcommittee 8
Stephen Berger
Chair

2. 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®.

3. Accredited Standards Committee C63® - EMC
Membership of Subcommittee 8
Changes since last meeting:
1 deletions from the membership – Stephen Whitesell 0 addition to the membership.
John Becker appointed as SC8 vice-chair.
Total members – 12 3

4. Accredited Standards Committee C63® - EMC
Membership of Subcommittee 8
Name
Role
Affiliation / Financial Support
Becker, John
Vice Chair
HIA
Berger, Stephen
Chair
TEM Consulting
Case, David
Member
CISCO
DeLisi, Bob
UL, LLC
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
Zimmerman, Dave
Spectrum EMC Consulting 4

5. 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

6. Accredited Standards Committee C63® - EMC
C63.18 On-site immunity testing of medical equipment
Document published: June 20, 2014

7. Accredited Standards Committee C63® - EMC
WG-2 C63.19 Hearing Aid compatibility
Invitation to join ballot group issued and closed Dec. 3, 2018.
MEC review of draft completed.
Ballot will begin as soon as the ballot group is formed.

8. Accredited Standards Committee C63® - EMC
Potential New Projects
A variety of topics that may result in new projects are being discussed. Among those topics are:
Alarms – What safeguards are expected when alarms are transmitted wirelessly? What actions are expected when an alarm fails to reach its intended destination?
Logging – What information related to wireless performance, e.g. failed packets, failed attempts to communicate, is recorded? When and where is this information reported?
Usefulness of PIM/PISM/PSM model for SC8 work – The Object Management Group has developed a detailed system to organize their standards to define performance while allowing companies technical freedom. The system includes:
PIM - platform-independent model
PISM - platform-independent simulation model
PSM – platform specific model

9. Accredited Standards Committee C63® - EMC
Potential New Projects
Life-Cycle Considerations – How are equipment aging issues incorporated into device evaluation and more broadly to the risk assessment process for devices?
Risk Assessment – What are the characteristics of a good or deficient risk assessment? Is more specific guidance needed on the testing risk category level?
GNURadio and SDR Technology. Is more tutorial and guidance needed for using spectrum record and playback for medical device testing? More broadly is the potential of software defined RF instrumentation being adequately applied to medical device evaluation.