1. 1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi Chair 2013-05-09

2. 2 Accredited Standards Committee C63 ® - EMC Membership of Subcommittee 8 NameRole within Subcommittee 8 - Andersen, PoulMember Attayi, DaoudMember Berger, StephenVice Chair Case, DavidMember Coston, SteveMember DeLisi, BobChair Green, KendraMember Griffin, AndyMember Hare, EdMember Hazem, RefaiMember Heirman, DonMember Hofmann, HR (Bob)Member Hoolihan, DanMember Hurst, BillMember Julstrom, SteveMember Knipple, TomMember Kozma-Spytek, LindaMember Kuczynski, VictorMember Liu, SteveMember Moongilan, DheenaMember Showers, RalphMember Silberberg, Jeffrey LMember Stumpf, BillMember Whitesell, SteveMember Witters, DonMember Zimmerman, DaveSecretary

3. 3 Accredited Standards Committee C63 ® - EMC Motions Membership Approval SC8 seeks approval from the Main Committee for the membership shown on the previous slide

4. 4 Accredited Standards Committee C63 ® - EMC Motions Scope Approval Subcommittee 8 is responsible for writing and maintaining existing and proposed C63 ® standards for medical devices, as assigned by the Main Committee ASC 63 ®. SC8 seeks approval from the Main Committee for the Scope shown

5. 5 Accredited Standards Committee C63 ® - EMC WG -1 C63.18 On-site immunity testing of medical equipment WG Chair reviewing work of IEEE editors Recirculation ballot before October 2013 Publication planned for late 2013 early 2014

6. 6 Accredited Standards Committee C63 ® - EMC WG-2 C63.19 Hearing Aid compatibility Participated in a meeting at the Audiologist convention (AAA) which included HIA, HLAA and others. The chair of the IEC WG was in attendance. A new revision of The IEC standard on hearing aid RF immunity is in the ballot process. Harmonization work will follow completion of the revision to the IEC standard, but it would most likely not happen until after the next 2013 SC8 fall meeting. An HLAA survey of hearing aid users reported more problems with HAC than anticipated. New technology devices (i.e. large tablet types) seem to be having issues with respect to HAC. The size of the geometric size of the T-coil field may be a problem. HLAA and Gallaudet University are conducting further user surveys to understand the issues.

7. 7 Accredited Standards Committee C63 ® - EMC Liaison Reports Participated in the 2012 Association for the Advancement of Medical Instrumentation (AAMI) Wireless Workshop Hospitals are reporting a variety of problems with wireless in hospitals. A task group has been organized to understand the issues involved. Several C63 members are on the task group and will facilitate liaison as appropriate.

8. 8 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) IEC 60601-1-2 Edition 4 C63.18 SC7 C63.27 WG on wireless interference and coexistence Significant increase in EMC reviews over the past 5 years 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 Developing guidance document on RF wireless technology in medical devices with a target of 2013 for posting date.

9. 9 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Asking medical device manufacturers to explicitly specify the intended use environments and asking for higher test levels for environments where they are warranted

10. 10 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 Draft IEC 60601-1-2 4 th Edition Voting on 62A/801A/CDV closed 17 August 2012 Vote was affirmative (78 %) Comments received: 475 Draft FDIS and response to comments will be completed in the next few weeks French translation: two months Ballot: two months Estimated publication Fall 2013