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Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)

Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs) Submission Title: [Regulation Issues Related to Medical Applications For IG-BAN] Date Submitted: [July, 2006] Source: [ Huan-Bang Li, Jun-ichi Takada, and Ryuji Kohno]

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Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)

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  1. Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs) Submission Title: [Regulation Issues Related to Medical Applications For IG-BAN] 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 P802.15. 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 P802.15.

  2. 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)

  3. Contents • EMC Standards/Regulation • IEC60601-1-2 • Medical Frequency Bands • Wireless Medical Telemetry (WMT) • Medical Implant Communications (MIC) • Licensing

  4. (I) EMC Standards/Regulation

  5. Some International Standardization On EMC(I) On Health Risk EvaluationWHO, IARC (II) Radiation Protection Safety LevelsICNIRP, IEEE/ICES C95.1 (III) Conformity Evaluation ITU-R/SG6, ITU-T/SG5, IEC/TC106, IEEE/ICES, IEC 60601-1-2, (EN45502-2-1, prEN45502-2-2, ANSI/AAMI PC69)

  6. EMC Regulations on Medical Equipment • IEC60601-1-2 (International) • Issued in September 2001. • EN IEC60601-1-2 (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.

  7. Classification On Medical Equipments According to Risk Analysis

  8. 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.

  9. 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.

  10. (II) Band Plan For Medical Applications

  11. 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

  12. 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

  13. Views From ITU and Japan (I)

  14. Views From ITU and Japan (II) • Additional note • All emissions in the band 1400-1427 MHz are prohibited. (ITU RR)

  15. WMT Band Plan Of Japan • Type A (BW < 8.5kHz) • Appointed bands between 420.05 – 449.6625 MHz • Type B (8.5kHz < BW < 16kHz) • Appointed bands between 420.0625 – 449.6375 MHz • Type C (16kHz < BW < 32kHz) • Appointed bands between 420.075 – 449.6 MHz • Type D (32kHz < BW < 64kHz) • Appointed bands between 420.1 – 449.525 MHz • Type E (64kHz < BW < 320kHz) • Appointed bands between 420.3 – 449.425 MHz • Except for 430 – 440 MHz (for amateur radio)

  16. WMT Band Plan Of EU and Others • EU: 608-614 MHz • Also used for radio astronomy • New Zealand: 202.65-205.15 MHZ • others?

  17. 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.

  18. Band Plan For MIC USA, EU, Japan, and others • 402 - 405 MHz frequency band • Shared and secondary basis.

  19. Facts On Band Plan • Different frequency bands for WMT in different countries or areas. • Different frequency bands for WMT and MIC.

  20. 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?

  21. (III) LicensingNon-licensed use of legal low-power short range device (SRD)

  22. Thank you for your attention !

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