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:[ ,
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 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

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)
Some International Standardization On EMC (I) On Health Risk Evaluation WHO, IARC (II) Radiation Protection Safety Levels ICNIRP, IEEE/ICES C (III) Conformity Evaluation ITU-R/SG6, ITU-T/SG5, IEC/TC106, IEEE/ICES, IEC , (EN , prEN , ANSI/AAMI PC69)

6. EMC Regulations on Medical Equipment
IEC (International)
Issued in September 2001.
EN IEC (EU)
Being fully effective from November 2004.
FDA/FCC UL 2601 (USA)
JIS T (Japan)
To be fully effective from April 2007.

7. Classification On Medical Equipments According to Risk Analysis
General Medical Equipments
Extremely low risk to human body
X-rays film, Surgery lighting II
Controlled Medical Equipments
Low risk to human body
Ultrasonic diagnosing devices, X-rays roentgen photograph
III
Highly Controlled Medical Equipments
High risk to human body
Artificial respiratory, Artificial dialysis IV
Extremely high risk to human body
Artificial heart valvular, Pacemaker

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 1395-1400 MHz 1427-1432 MHz
Also for radio astronomy and UHF TV
MHz
MHz
Also used for non-medical telemetry

13. Views From ITU and Japan (I)
Frequency [MHz]
ITU
MIC Japan
Broadcasting
(TV channel 36)
Radiolocation
Fixed (Reg 1)
Mobile (Reg 1)
[not used]
Space operation (earth-to-space)
Fixed
Mobile
Mobile uplink (TuKa in TON; Vodafone in others)

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

15. WMT Band Plan Of Japan Type A (BW < 8.5kHz)
Appointed bands between – MHz
Type B (8.5kHz < BW < 16kHz)
Appointed bands between – MHz
Type C (16kHz < BW < 32kHz)
Appointed bands between – MHz
Type D (32kHz < BW < 64kHz)
Appointed bands between – MHz
Type E (64kHz < BW < 320kHz)
Appointed bands between – MHz
Except for 430 – 440 MHz (for amateur radio)

16. WMT Band Plan Of EU and Others
EU: MHz
Also used for radio astronomy
New Zealand: 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
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) Licensing Non-licensed use of legal low-power short range device (SRD)

22. Thank you for your attention !