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

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Accredited Standards Committee C63® - EMC

Subcommittee 8

Bob DeLisi

Chair

2015 May 07

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Motions

SC8 seeks approval from the Main Committee for membership, duties and scope as documented on next 3 slides

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Membership of Subcommittee 8

Total members - 21

Name Subcommittee 8 Role Affiliation

Andersen, Poul Member Poul Andersen Consulting Attayi, Daoud Member Blackberry Corporation Berger, Stephen Vice Chair TEM Consulting Case, David Member CISCO Coston, Steve Member PCTEST Engineering Laboratory, Inc. DeLisi, Bob Chair Underwriters Laboratory Griffin, Andy Member CISCO Systems Hare, Ed Member ARRL Hazem, Refai Member University of Oklahoma Heirman, Don Member Don HEIRMAN Consultants Hoolihan, Dan Member Hoolihan EMC Consulting Hurst, Bill Member FCC Knipple, Tom Member Motorola Mobility Kuczynski, Victor Member Vican Electronics Liu, Steve Member PCTEST Engineering Laboratory, Inc. Moongilan, Dheena Member Alcatel-Lucent Technologies Silberberg, Jeffrey L Member FDA Center for Devices & Radiological Health Stumpf, Bill Member DLS Electronics Whitesell, Steve Member Consultant Witters, Don Member FDA Center for Devices & Radiological Health Zimmerman, Dave Secretary Spectrum EMC Consulting, LLC

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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 StandardMethods of Measurement ofCompatibility between WirelessCommunications Devices andHearing Aids

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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®.

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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.

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Motions

SC8 seeks approval from the Main Committee to approve a PINS-C to study new work items for C63.19.

Microsoft Word 97 - 2003 Document

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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 60601-4-2 (medical performance) and 60601-1-2 (5th Edition), ISO/TS 10974.

• 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

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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)

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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

• Once circulated there will be a 3-month comment period.

• Does not contain emissions requirements (assumed covered in IEC 60601-1-2)

• IEC 60601-1-2 – 62A/992/DC (will be 5th Edition)

• Comment period closes 2015-05-08

• Estimated publication 2019

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Liaison Reports

• AAMI• Don Heirman will be stepping down as co-chair of the EMC group a

the end of the annual convention in 2015.

• 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.

Documents

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