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AAMI TIR18:2010

AAMI TIR18:2010

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AAMI TIR18:2010
Guidance on electromagnetic compatibility of medical devices in healthcare facilities
Association for the Advancement of Medical Instrumentation / 04-May-2010 / 78 pages

This AAMI Technical Information Report (TIR) provides information, guidance, and general recommendations regarding electromagnetic compatibility (EMC) of medical devices and the use of wireless technology in healthcare facilities to promote patient safety. It is intended to provide a broad range of information about EMC of medical devices for clinical and biomedical engineers and other technical personnel, healthcare administrators including heads of hospital departments, medical staff, and healthcare associations. The information herein will help healthcare organizations evaluate their electromagnetic environment and implement actions needed to minimize electromagnetic interference (EMI) problems and manage the EM environment including wireless RF sources. While this TIR focuses on healthcare facilities, the home environment is briefly addressed. Management of the electromagnetic environment and management of medical devices for EMC are discussed, as are: assessment of the electromagnetic environment; investigation and reporting of EMI problems; selected case studies in EMI problems; site selection, design, and construction of new facilities; a model EMC and wireless policy and guidance for developing EMC and wireless policies; and principles of electromagnetic energy and interference mechanisms. Definitions of terms and a bibliography are also provided.

Contents
NOTE—Following each section cited below is a code to indicate which of the following readers should pay particular attention to that
section. An acronym/abbreviation will be used for convenience:
Healthcare administrators, including hospital heads (ADMIN)
Patient safety/risk management personnel (PSRM)
Clinical/biomedical engineers and other technical personnel (TECH)
Medical staff (MED)
Healthcare associations (HCA)
All readers (ALL)
Page
Glossary of equivalent standards ......................vii
Committee representation ......ix
Foreword ......x
1 Introduction and scope (ALL) .....................1
2 Definitions and abbreviations (ALL) ...........1
3 General recommendations (ALL) ...............5
3.1 Overview..................5
3.2 Focal point for EMC.5
3.3 EMC and wireless technology coordination ..................5
3.4 Policies and procedures.....................5
3.5 Resources ...............5
3.6 Ad hoc immunity testing.....................5
3.7 Ad hoc immunity testing (close distance)......................5
3.8 Coordination of equipment purchase, installation, servicing, and management................6
3.9 Standards ................6
3.10 Education...............6
3.11 EMI problems.........6
3.12 RF transmitters ......6
3.13 List of RF sources..6
3.14 RF spectrum usage6
3.15 Electronic medical devices used near high-power RF sources .............6
3.16 EMC test reports....6
3.17 Facility considerations......................6
3.18 "No problem found"6
3.19 EMC professionals.6
4 Assessment of the electromagnetic environment in existing facilities (TECH) .........................7
4.1 Overview..................7
4.2 Identification of RF sources ................7
4.3 Identification of areas where critical medical devices are used...............9
4.4 Ambient electromagnetic measurements......................9
5 Management of the electromagnetic environment (TECH, ADMIN, PSRM, MED) ..................10
5.1 Overview..................10
5.2 RF spectrum management .................10
5.3 On-site portable and mobile RF sources.......................10
5.3.1 General considerations.........10
5.3.2 Categories of RF communications equipment users ................10
5.3.3 Portable and mobile RF source management strategies ..........11
5.4 On-site fixed RF sources ....................16
5.4.1 General considerations.........16
5.4.2 Pager transmitters ................16
5.4.3 Commercial and safety service RF repeaters and cellular and PCS base stations ......................16
5.4.4 Outside RF sources..............16
5.5 Management of unintentional (incidental) sources of RF energy ............19
5.6 Separation-distance considerations ....19
5.7 ESD mitigation .........22
5.8 AC power distribution system management..................22
5.9 Cable management..22
6 Management of medical devices for EMC (TECH, ADMIN, PSRM)...............22
6.1 Overview..................22
6.2 New medical devices .........................22
6.3 Existing medical devices....................23
6.3.1 General considerations ..............23
6.3.2 System mitigation......................23
6.3.3 Service and maintenance ..........24
6.4 Ad hoc RF immunity testing ................24
6.5 Medical devices for home-care, mobile, and telemedicine use ...............26
6.6 Implantable medical devices ...............27
7 Identification, investigation, and reporting of EMI problems (TECH, MED, ADMIN, PSRM) ....27
7.1 Overview..................27
7.2 Identification and investigation ............27
7.3 Reporting .................28
8 Site selection, design, and construction of facilities (TECH, ADMIN, HCA) ...29
8.1 Overview..................29
8.2 New construction .....29
8.3 Modifications of existing facilities ........30
8.4 Floor planning ..........30
8.5 EMC professional help.......................30
9 Education and training (ALL).....................30
9.1 Overview..................30
9.2 Scope of education and training..........30
9.3 Resources................30
Annexes
A Principles of electromagnetic energy and interference mechanisms (TECH).31
B Selected case studies in EMI problems (TECH, MED, PSRM)......................37
C Model electromagnetic compatibility (EMC) and radiofrequency wireless technology policy and guidance
for developing EMC and wireless policies (ADMIN, PSRM, HCA) .................43
D Overview of surveys of electromagnetic environments associated with healthcare facilities (TECH).................52
E Example of manufacturer declaration of electrosurgical generator meeting IEC 60601-1-2 (TECH,
ADMIN, MED)..........54
F Bibliography (ALL)...........59
Tables
1 Groups requiring coordination and communication regarding medical device EMC and wireless
technology for assurance of patient and staff safety ............5
2 Examples of rooftop transmitters at a hospital .....................17
3 General description of common wireless technologies.........20
4 Approximate minimum separations ............21
A.1 Example solutions of equation 1 ................33
A.2 Typical portable and mobile transmitters, frequencies, output power, and estimated field strength at
1 meter..34
A.3 Fixed transmitters, frequencies, maximum licensed radiated power, and estimated field strength at
1 kilometer ......................35
A.4 Example solutions to equation 4 for k = 7 and E = 3 V/m.....36
E.1 Guidance and manufacturer’s declaration—electromagnetic emissions ........55
E.2 Guidance and manufacturer’s declaration—electromagnetic immunity..........56
E.3 Guidance and manufacturer’s declaration―electromagnetic immunity..........57
E.4 Recommended separation distances between portable and mobile RF communications equipment and
the generator...................58
Figures
1 Example arrangement of antennas on 9th floor roof of a hospital ...................18
2 Guidance on when to perform ad hoc RF immunity testing..25