July 19 2006 Doc IEEE 802 15 06

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Project: IEEE P 802. 15 Working Group for Wireless Personal Area Networks (WPANs) Submission Title: [Regulation Issues Related to Medical Applications For IGBAN] Date Submitted: [July, 2006] Source: [Huan-Bang Li, Jun-ichi Takada, and Ryuji Kohno] Company [National Institute of Information and Communications Technology (NICT)] Contact: Huan-Bang Li. Voice: [+81 46 847 5104, E-Mail: lee@nict. go. jp] Abstract: [Some regulation topics on medical applications] Purpose: [To provide regulation background for IG-BAN] Notice: This document has been prepared to assist the IEEE P 802. 15. It is offered as a basis for discussion and is not binding on the contributing individual(s) or organization(s). The material in this document is subject to change in form and content after further study. The contributor(s) reserve(s) the right to add, amend or withdraw material contained herein. Release: The contributor acknowledges and accepts that this contribution becomes the property of IEEE and may be made publicly available by P 802. 15. Slide 1 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Regulation Issues Related to Medical Applications of IG-BAN Huan-Bang Li, Jun-ichi Takada, and Ryuji Kohno National Institute of Information and Communications Technology (NICT) Slide 2 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Contents • EMC Standards/Regulation – IEC 60601 -1 -2 • Medical Frequency Bands – Wireless Medical Telemetry (WMT) – Medical Implant Communications (MIC) • Licensing Slide 3 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban (I) EMC Standards/Regulation Slide 4 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Some International Standardization On EMC (I) On Health Risk Evaluation WHO, IARC (II) Radiation Protection Safety Levels ICNIRP, IEEE/ICES C 95. 1 (III) Conformity Evaluation ITU-R/SG 6, ITU-T/SG 5, IEC/TC 106, IEEE/ICES, IEC 60601 -1 -2, (EN 45502 -2 -1, pr. EN 45502 -2 -2, ANSI/AAMI PC 69) Slide 5 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban EMC Regulations on Medical Equipment • IEC 60601 -1 -2 (International) – Issued in September 2001. • EN IEC 60601 -1 -2 (EU) – Being fully effective from November 2004. • FDA/FCC UL 2601 (USA) – Being fully effective from November 2004. • JIS T 0601 -1 -2 (Japan) – To be fully effective from April 2007. Slide 6 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Classification On Medical Equipments According to Risk Analysis General Medical Equipments Extremely low risk to human body X-rays film, Surgery lighting Controlled Medical Equipments Low risk to human body Ultrasonic diagnosing devices, Xrays roentgen photograph III Highly Controlled Medical Equipments High risk to human body Artificial respiratory, Artificial dialysis IV Highly Controlled Medical Equipments Extremely high risk to human body Artificial heart valvular, Pacemaker I II Slide 7 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Risk Analysis Is Required • First, a clear definition on basic function of a medical equipment is required. Then, it is required to give an analysis on possible risks when the equipment fails to operate correctly. • If an ICT equipment connected to a medical system does not affect the basic function of the medical system, the ICT equipment can only apply with the non-medical EMC standard. Slide 8 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Questions For BAN • Is it possible to only apply non-medical standards for BAN devices? • In the four classifications of medical equipments, where should BAN belong to? • Outside and inside body applications may belong to different classifications. Slide 9 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban (II) Band Plan For Medical Applications Slide 10 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Wireless Medical Telemetry (WMT) The measured physiological parameters and other patient related information are transmitted via RF communication between a patient-worn transmitter and a remote monitoring unit Slide 11 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban WMT Band Plan Of FCC • 608 -614 MHz – Also for radio astronomy and UHF TV • 1395 -1400 MHz • 1427 -1432 MHz – Also used for non-medical telemetry Slide 12 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Views From ITU and Japan (I) Frequency [MHz] ITU MIC Japan 608 -614 Broadcasting (TV channel 36) 1395 -1400 Radiolocation Fixed (Reg 1) Mobile (Reg 1) Radiolocation [not used] 1427 -1429 Space operation (earth-to-space) Fixed Mobile Space operation (earth-to-space) [not used] 1429 -1432 Fixed Mobile uplink (Tu. Ka in TON; Vodafone in others) Slide 13 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Views From ITU and Japan (II) • Additional note – All emissions in the band 1400 -1427 MHz are prohibited. (ITU RR) Slide 14 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban WMT Band Plan Of Japan • Type A (BW < 8. 5 k. Hz) – Appointed bands between 420. 05 – 449. 6625 MHz • Type B (8. 5 k. Hz < BW < 16 k. Hz) – Appointed bands between 420. 0625 – 449. 6375 MHz • Type C (16 k. Hz < BW < 32 k. Hz) – Appointed bands between 420. 075 – 449. 6 MHz • Type D (32 k. Hz < BW < 64 k. Hz) – Appointed bands between 420. 1 – 449. 525 MHz • Type E (64 k. Hz < BW < 320 k. Hz) – Appointed bands between 420. 3 – 449. 425 MHz • Except for 430 – 440 MHz (for amateur radio) Slide 15 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban WMT Band Plan Of EU and Others • EU: 608 -614 MHz – Also used for radio astronomy • New Zealand: 202. 65 -205. 15 MHZ • others? Slide 16 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Medical Implant Communications (MIC) Data in support of diagnostic or therapeutic functions associated with medical implemented devices (MID) are transmitted via RF communications between MID and a remote monitoring unit. Slide 17 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Band Plan For MIC USA, EU, Japan, and others • 402 - 405 MHz frequency band – Shared and secondary basis. Slide 18 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Facts On Band Plan • Different frequency bands for WMT in different countries or areas. • Different frequency bands for WMT and MIC. Slide 19 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Some Issues To Be Considered in IG-BAN • A world wide unified band plan is important in defining a common PHY. – Other frequency bands instead of WMT? • MIC is assigned with different frequency bands from WMT. – Different definition from WMT? – Interface between WMT and MIC? Slide 20 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban (III) Licensing Non-licensed use of legal low-power short range device (SRD) Slide 21 Li, Takada, Kohno

July 19, 2006 Doc: IEEE 802. 15 -06 -0340 -00 -0 ban Thank you for your attention ! Slide 22 Li, Takada, Kohno