ISO TR 21730-2007 Health informatics - Use of mobile wireless communication and computing technology in healthcare facilities - Recommendations for electromagne.pdf

1、 Reference number ISO/TR 21730:2007(E) ISO 2007TECHNICAL REPORT ISO/TR 21730 Second edition 2007-02-15 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagne

2、tic interference) with medical devices Informatique de sant Utilisation des communications mobiles sans fil et des technologies informatises dans les structures de soins Recommandations pour la compatibilit lectromagntique (gestion des interfrences lectromagntiques non intentionnelles) avec les disp

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6、at at the address given below. ISO 2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address

7、 below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reservedISO/TR 21730:2007(E) ISO 2007 All rights res

8、erved iii Contents Page Foreword iv Introduction v 1 Scope 1 2 Terms, definitions and abbreviated terms 1 2.1 Terms and definitions .1 2.2 Abbreviated terms .1 3 Current status of management of electromagnetic interference3 3.1 Mobile wireless equipment in healthcare facilities 3 3.2 The risk of pat

9、ient harm due to EMI.5 3.3 Existing relevant standards and recommendations 6 3.4 EMC with medical devices and minimization of EMI risk 8 4 Recommendations.9 4.1 General recommendations .9 4.2 Responsibility within healthcare facilities 10 4.3 Inventory within healthcare facilities.10 4.4 Testing wit

10、hin healthcare facilities 11 4.5 Controlled use within healthcare facilities12 4.6 Non-controlled use within healthcare facilities 13 4.7 RF emissions from network sources.14 4.8 Medical devices within healthcare facilities .14 Annex A (informative) RF technologies 15 Bibliography 34 ISO/TR 21730:20

11、07(E) iv ISO 2007 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body

12、interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotech

13、nical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by t

14、he technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from that which is

15、normally published as an International Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it provides are

16、considered to be no longer valid or useful. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 21730 was prepared by Technical Committee ISO/TC 2

17、15, Health informatics, Task Force on EMC in RF mobile communications. Other international organizations that contributed to the preparation of this Technical Report, mainly in review and comment of the draft text, include: from the UK, the MHRA and the IST/35 Mirror Panel; from the US, the FDA; fro

18、m Australia, the Australian Therapeutic Goods Administration, Telstra and Monash Medical Center; from Canada, Health Canada Medical Devices Bureau; from the Netherlands, the Health Council of the Netherlands; from Finland, the National Agency for Medicines; and from Switzerland, Swissmedic. Due to r

19、apidly changing technologies, this Technical Report is to be regarded as a living document and comments for improvement will therefore be welcomed. This second edition of ISO/TR 21730 cancels and replaces the first edition (ISO/TR 21730:2005), which has been technically revised. ISO/TR 21730 strongl

20、y parallels AAMI TIR No.18, which provides similar recommendations for wireless equipment in healthcare facilities. Many of the recommendations developed within this TR are directly built upon the foundation of earlier documents, such as AAMI TIR No.18 and ANSI/IEEE C63.18. ISO/TR 21730:2007(E) ISO

21、2007 All rights reserved v Introduction Worldwide, healthcare facilities are recognizing the need to incorporate new technology and provide better point-of-care information to improve healthcare delivery, while reducing medical errors. Computing technologies, electronic medical record systems, and s

22、eamless access to information using wireless communication can offer significant advancements to healthcare communication and health informatics exchange. Such wireless technologies include the use of mobile phones, handheld computers/PDAs, WiFi/802.11.x local area networks, personal area networks i

23、ncluding 802.15.1 (Bluetooth)/802.15.4 (Zigbee)/802.15.3a (UWB), two-way pagers, radios, etc. In addition, visitors and patients are also finding the use of personal mobile phones and other wireless devices increasingly valuable, especially in times of crisis. Previously, no uniform international gu

24、idelines existed for the appropriate deployment, use and management of mobile wireless communication and computing technology within healthcare facilities to address electromagnetic compatibility (EMC) with medical devices and mitigate potential electromagnetic interference (EMI). Although the recen

25、tly approved second edition of IEC 60601-1-2 (IEC 60601-1-2:2001) specifies general immunity levels of 3 V/m for medical equipment and systems that are not life-supporting, and 10 V/m for life-supporting medical equipment and systems, manufacturers are allowed to justify lower levels and there is no

26、 consistent international regulation enforcing this standard. In addition, many mobile wireless transmitters exceed these field strength thresholds when operating at their upper power limits and in close proximity. Finally, there are a number of older medical devices still in use that have not been

27、designed or tested with the above immunity considerations in mind. At present, there appears to be a range of inconsistent policies among healthcare organizations with regards to EMC, mobile wireless systems and management procedures. At one extreme, overly-restrictive policies may inadvertently act

28、 as obstacles to the deployment of beneficial technology. At the other extreme, the unmanaged use of wireless electromagnetic radiation emitters can place patients at risk. An equally important factor in this issue is that healthcare organizations throughout the world have a variety of different res

29、ources, needs, concerns and RF environments that may not all be addressed by the implementation of a single prescriptive management strategy. Because of this, a balanced approach is necessary to ensure that all the benefits of mobile wireless technology can be made available to healthcare organizati

30、ons, while providing necessary and sufficient safeguards against undesired and unintended risks of EMI. It may not be feasible for healthcare organizations to manage every mobile wireless handset brought into their facility without certain restrictive limits. The necessary range and extent of restri

31、ctive limits within a given healthcare facility will depend upon the level of management that has been implemented. For mobile wireless equipment that is randomly brought into the healthcare facility in an uncontrolled manner, policies may be appropriate that restrict use of wireless equipment in ar

32、eas where potentially susceptible medical devices are in routine operation. Such restrictive policies might be facilitated by offering numerous and easily accessible alternative areas where the use of mobile wireless equipment is permitted. For mobile wireless equipment that is provided to doctors a

33、nd staff under more controlled conditions, operation throughout the healthcare facility (even in areas where potentially susceptible medical devices are used) may be achievable with appropriate management. With such management, as outlined in the recommendations below, it is possible to realize many

34、 of the benefits of wireless technology for healthcare-specific communication and health information access, while at the same time sufficiently mitigating EMI concerns and create effective EMC among medical devices and wireless technology. Because most mobile wireless communication and computing sy

35、stems can be effectively managed for EMC with medical devices, the choice of wireless technology to be deployed in a healthcare facility and managed in a dedicated manner should be based upon the solution that best addresses the needs of the organization and benefit for patients, not on the potentia

36、l of specific RF transmitter types to cause EMI when used under non- controlled conditions. TECHNICAL REPORT ISO/TR 21730:2007(E) ISO 2007 All rights reserved 1 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnet

37、ic compatibility (management of unintentional electromagnetic interference) with medical devices 1 Scope This Technical Report provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective e

38、lectromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given recognize the different resources, needs, concerns and environments of healthcare organizations aro

39、und the world, and provide detailed management guidelines for healthcare organizations that desire full deployment of mobile wireless communication and computing technology throughout their facilities. In addition, suggestions are included for selective restrictions in cases where healthcare organiz

40、ations have decided that comprehensive management procedures are not feasible, practical or desirable at the present time. The recommendations herein distinguish between wireless technology controlled by the facility and used by doctors and staff for healthcare-specific communication and health info

41、rmatics transport versus non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients or the healthcare organization workforce. 2 Terms, definitions and abbreviated terms 2.1 Terms and definitions For the purposes of this document, the following terms

42、and definitions apply. 2.1.1 hertz Hz unit of frequency of electromagnetic energy based upon the emitted wavelength 2.1.2 decibel dB relative ratio, one-tenth of the common logarithm of the ratio of relative powers, equal to 0,1 B (bel) NOTE 1 The ratio in decibels equals 10 lg 10 (P 1 /P 2 ). NOTE

43、2 Decibels as above, but relative to a fixed 1 mW of power, are sometimes indicated as dBm. 2.2 Abbreviated terms ASHE American Society for Healthcare Engineering AAMI Association for the Advancement of Medical Instrumentation ISO/TR 21730:2007(E) 2 ISO 2007 All rights reservedAHA American Hospital

44、Association AMA American Medical Association ANSI American National Standards Institute CDRH Center for Devices and Radiological Health, Department within FDA (US) CISPR International Special Committee on Radio Interference COMAR IEEE Committee on Man and Radiation ECG Electrocardiogram EEG Electroe

45、ncephalogram EM Electromagnetic EMC Electromagnetic compatibility EMD Electromagnetic disturbance EMI Electromagnetic interference ESD Electrostatic discharge FDA Food and Drug Administration (US) IEC International Electrotechnical Commission IEEE Institute for Electrical and Electronics Engineers I

46、SM Industrial, Scientific, Medical IVDs In vitro diagnostic devices JCAHO Joint Commission on Accreditation of Healthcare Organizations LAN Local Area Network, including 802.11b and 802.11a systems MHRA Medicines and Healthcare Products Regulatory Agency (UK) PAN Personal Area Network, including 802

47、.15.1 (Bluetooth), 802.15.4 (Zigbee), 802.15.3a, etc. PDA Personal digital assistant R&TTE Radio and Telecommunications Terminal Equipment RF Radiofrequency, classically defined as ranging from a few kHz - 300 GHz Rx Reception, received RF signal TIR Technical informational report Tx Transmission, t

48、ransmitted RF signal UWB Ultra-wideband, refers to RF transmissions spread over at least 500 MHz of spectrum or a fractional bandwidth of 0,2, with a very low spectral density at any given frequency ( 41,3 dBm/MHz) ISO/TR 21730:2007(E) ISO 2007 All rights reserved 3 V/m Volts per metre, a measure of

49、 RF electrical field strength WiFi Wireless Fidelity Network system 3 Current status of management of electromagnetic interference 3.1 Mobile wireless equipment in healthcare facilities The use of mobile wireless equipment by medical healthcare staff to provide point-of-care communication and patient information is increasingly being recognized as required to reduce medical errors and to improve healthcare delivery. Visitors and patients are likewise finding the use of personal mobile (i.e. cellular) phones and wireless devices incre