1. 1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi Chair 2015 November 11

2. 2 Accredited Standards Committee C63 ® - EMC Motions SC8 seeks approval from the Main Committee for leadership change New Subcommittee 8 Chair – Stephen Berger

3. Accredited Standards Committee C63 ® - EMC FCC released NPRM (FCC 15-144) https://www.fcc.gov/document/hearing-aid-compatibility- standards-nprm –NPRM is a result of request for TIA to address new test methods for wireline devices –NPRM includes new wireless technologies related to HAC. –SC8 will be working on a response to the NRPM since it specifically address C63.19:2011 (endorses only to use this edition). NPRM is not yet published in Federal Register as of this update report so response will be prepared after publication and before the due date. 3 WG-2 C63.19 Hearing Aid compatibility

4. 4 Accredited Standards Committee C63 ® - EMC Motions SC8 seeks approval from the Main Committee to approve a PINS to revise C63.10 to address FCC and industry concerns

5. 5 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Research: Round robin evaluation of draft C63.27 conducted and radiated test methods Lab assessment of AIM/REG standard for immunity of medical devices to RFID New Draft Guidance Document - Information to Support a Claim of EMC of Electrically-Powered Medical Devices http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuida nce/GuidanceDocuments/UCM470201.pdf?source=govdelivery&utm_medi um=email&utm_source=govdeliveryhttp://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuida nce/GuidanceDocuments/UCM470201.pdf?source=govdelivery&utm_medi um=email&utm_source=govdelivery 9 items that are to be submitted to show EMC compliance First 8 are related to what should be in an EMC test report Last item is declaration from the manufacturer based on any changes made during testing.

6. 6 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) AAMI/FDA Co-chair of wireless coexistence technical information report Draft TIR 69, Risk Assessment of radiofrequency wireless coexistence for medical devices and systems Co-chair of working group – EMC test protocols for cardiac rhythm management Working on EMC section of a standard for cochlear implants Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Published June/July 2015 3 November 2015 that the document was approved for “elevation to a standard”

7. 7 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) FDA/FCC Met 10 June 2015 Discussions revolved around Wireless Power Transfer (WPT) and RF Exposure. FDA indicated it was not necessary change RF Exposure limits to address WPT. Next meeting 1 December 2015

8. 8 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 IEC/TR 60601-4-2: 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 Comment period ended 14 August 2015 130 NC comments received Draft Technical Report (DTR) and responses to comments submitted to Secretary, SC62A, 3 November 2015 for circulation

9. 9 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 Adoption of IEC 60601-1-2:2014 FDA recognition Both IEC and ANSI/AAMI/IEC versions recognized Transition from Ed 3 (2007) 1 April 2017 Europe Date of ratification: 2015-09-03 Date of availability: 2015-09-18 Date of publication: 2016-03-18 Date of withdrawal: 2018-12-31

10. 10 Accredited Standards Committee C63 ® - EMC Liaison Reports AAMI A Joint communication to stakeholders in healthcare regarding low humidity in operating environments was issued. Includes background of the possibility of low humidity levels and impact of ESD. Contains a Risk Assessment: 8 questions that when answered will help a healthcare facility understand the impact of implementing a low level humidity levels (below 30%). A summary report of healthcare facility use of wireless devices was provided. Report shows how many facilities use wireless device, what types of devices and what frequency bands are used. Wireless devices studied included medical and non-medical.