1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi Chair 2015 May 07

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 Accredited Standards Committee C63 ® - EMC Membership of Subcommittee 8 Total members - 21

4 Accredited Standards Committee C63 ® - EMC Duties of Subcommittee 8 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

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 C63 ®.

6 Accredited Standards Committee C63 ® - EMC WG-2 C63.19 Hearing Aid compatibility User Experience - HLA (Hearing Loss Association of America) continues to poll users for Hearing Aid Compatibility issues. Currently 25% of those polled are claiming issues when using wireless phones. At this time it is unknown if the issues are related to technical issues or to user use issues. As findings are studied it is possible that C63.19 will need further revision to address the uncovered issues. FCC indicated that there were 4 areas they would like C63.19 to address Voice over Wi-Fi Voice over LTE Simultaneous Transmission Volume Control on Handsets and interaction with hearing aids. The items above are the main reasons for a PINS-C to be developed.

7 Accredited Standards Committee C63 ® - EMC Motions SC8 seeks approval from the Main Committee to approve a PINS-C to study new work items for C63.19.

8 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Currently Activities include: Susceptibility of patient cables of automatic external defibrillators below 80 MHz and comparison of results of conducted and radiated immunity testing Participating in a round robin evaluation of C63.27 conducted and radiated test methods. FDA is currently working on the following standards: C63.12, C63.16, C63.27, IEC (medical performance) and (5 th Edition), ISO/TS FDA is the co-chair of AAMI of wireless coexistence, Co-chair of working group – EMC test protocols for cardiac rhythm management and they are working on a standard for cochlear implants

9 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) AAMI/FDA work on Humidity in the operating room American Society of Heating, Refrigeration and Air Conditioning (ASHRAE) changed national minimum recommendation from 30% to 20%. While it was decided this change was OK for sterility equipment effects were not considered. Joint FCC/FDA meeting addressing Wireless Medical Test Beds Primarily dealing with coexistence. Continued work for RFID Protocol testing with Automatic Identification and Mobility (AIM Global) RFID Experts Group (REG) Protocol completed and under review (comments due 22 May 2015)

10 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 IEC/TR : Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems Submitted to Secretary, SC62A, May 1, 2015 Once circulated there will be a 3-month comment period. Does not contain emissions requirements (assumed covered in IEC ) IEC – 62A/992/DC (will be 5 th Edition) Comment period closes Estimated publication 2019

11 Accredited Standards Committee C63 ® - EMC Liaison Reports AAMI Don Heirman will be stepping down as co-chair of the EMC group a the end of the annual convention in Work is being conducted to study the impact of humidity effects in operating suites. This work may have an opportunity to introduce the latest edition of C63.16 into what ever procedures are developed. Don will be overseeing this.