1. 1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi Chair 2014-04-31

2. 2 Accredited Standards Committee C63 ® - EMC Motions SC8 seeks approval from the Main Committee for membership, duties and scope as documented on next 3 slides

3. 3 Accredited Standards Committee C63 ® - EMC Membership of Subcommittee 8 Total members - 22

4. 4 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

5. 5 Accredited Standards Committee C63 ® - EMC Scope of Subcommittee 8 Subcommittee 8 is responsible for writing and maintaining existing and proposed C63 ® standards for medical devices, as assigned by the Main Committee ASC 63 ®.

6. 6 Accredited Standards Committee C63 ® - EMC WG -1 C63.18 On-site immunity testing of medical equipment Recirculation ballot was o pened 4/8/2014 and Closed 4/29/2014 14 voters in the ballot pool 5 approvals 5 approval carried forward 2 approvals with comments 2 abstain 0 disapprovals Document Passed. Comments are being addressed and will be sent for IEEE processing and publication.

7. 7 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. Discussions on insight to issues is being looked at by HLAA. Other new items that the HAC community is looking at is use of LTE into the 5GHz band and 60GHz WiFi which may be issues for hearing aids which is currently only tested to 2.4GHz

8. 8 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Currently participating on the following working groups; C63.18, C63.12, C63.16 and C63.27 Significant increase in EMC reviews including medical devices with wireless capability 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

9. 9 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) IEC 60601-1-2:2014 Working towards recognition of IEC 60601-1-2:2014 (4 th edition) by mid 2014 Transition from IEC 60601-1-2:2007 (3 rd Edition) to IEC 60601-1- 2:2014 by mid 2017 As of right now FDA will adopt the standard in full except Table 8, 61000-4-6 row, exemption of I/O cables < 3 m long In process of developing a Guidance for Design Considerations for Devices Intended for Home Use It will be Harmonized with IEC 60601-1-11 Final version under development

10. 10 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 IEC 60601-1-2 4 th Edition Published on February 25, 2014 Amendment 1 already in progress Former Annex J (removed from 4 th edition) will become a Technical Report with respect to Electromagnetic Compatibility (EMC Performance)

11. 11 Accredited Standards Committee C63 ® - EMC Liaison Reports AAMI Annual symposium scheduled for the first week of June. Award will be given to the AAMI EMC committee for work on IEC 60601-1-2 (4th edition).