Presentation on theme: "1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi / Stephen Berger Chair / Vice-Chair 2014-11-11."— Presentation transcript:
1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi / Stephen Berger Chair / Vice-Chair 2014-11-11
2 Accredited Standards Committee C63 ® - EMC Motions No Motions requested from SC8
3 Accredited Standards Committee C63 ® - EMC Membership of Subcommittee 8 No additions or deletions from the membership Total members - 22
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 Accredited Standards Committee C63 ® - EMC WG -1 C63.18 On-site immunity testing of medical equipment Document published: June 20, 2014 Thanks to Jeff Silberberg for all his efforts to get this document published.
6 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. Both C63 and TIA have published standards the FCC recognizes for HAC TIA – Landline phones C63 – Mobile phones Hearing Industries Association, HIA, has gotten involved HIA has reached out to WG-2 Chair for assistance in trying to figure out what the issues are. At this time no action is required by C63 but C63.19 may need to change in the future to address the issues once they are uncovered.
7 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Working Group Status Since all work in C63.18 and C63.19 is completed these working goups are disbanded until new work times are needed. HAC information will be provide as a Liaison report until such a time that work is needed by C63 Subcommittee 8. No New Work requests have been made to the Subcommittee.
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; C63.12, C63.16 and C63.27 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 Working on IEC 61000-4-39: Radiated fields in close proximity immunity test (77B/717/CD) which was removed from IEC 60601-1-2.
9 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) IEC 60601-1-2:2014 FDA has recognized IEC and AAMI versions of 60601-1-2:2014 (4 th edition). Recognition was Mid 2014. Transition from IEC 60601-1-2:2007 (3 rd Edition) to IEC 60601-1- 2:2014 by mid April 1, 2017 FDA has adopted the standard in full except Table 8, 61000-4-6 row, exemption of I/O cables < 3 m long
10 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) AAMI activities within the FDA include Co-chair of wireless coexistence TIR working group Co-chair of working group – EMC test protocols for cardiac rhythm management Working on EMC section of a standard for cochlear implants Specifications for Humidity in the operating room (for equipment) ISO activities within the FDA Working on the second edition of ISO/TS 10974, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
11 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Released Final Guidance: Design Considerations for Devices Intended for Home Use Announced on August 5, 2014 Harmonized with IEC 60601-1-11 References ANSI/AAMI/IEC 60601-1-2:2014 for EMC Will be revised with immunity test levels that are recommended for use with 60601-1-2:2007 FDA involvement with Wireless Coexistence Continued work on C63.27 as well as working with AAMI and OU Tulsa Ongoing meetings with FCC and SAE on wireless chargers for automobiles.
12 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 IEC 60601-1-2 4 th Edition Amendment 1 already in progress since publication of 4 th edition. 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 Circulated on October 24 as 62A/971/CD IEC 61000-4-39: Electromagnetic compatibility (EMC) – Part 4-39: Testing and measurement techniques – Radiated fields in close proximity immunity test (77B/717/CD) Comments were due 10-10-2014
13 Accredited Standards Committee C63 ® - EMC Liaison Reports AAMI AAMI TIR18 Ed. 2 - Publication 2013: References C63.18 Used by clinical and biomedical engineers AAMI has also recognized the 4 th edition of IEC 60601-1- 2:2014