AAMI TIR18 2010
$140.32
AAMI TIR18:2010 – Guidance on electromagnetic compatibility of medical devices in healthcare facilities
| Published By | Publication Date | Number of Pages |
| AAMI | 2010 | 78 |
This AAMI Technical Information Report (TIR) provides information, guidance, and general recommendations regarding electromagnetic compatibility (EMC) of medical devices and the use of RF 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 (EM) environment and implement actions needed to minimize electromagnetic interference (EMI) problems and manage the EM environment, including wireless RF sources. Although 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 the following subjects: 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR18:2010, Guidance on electromagnetic compatibility of medical devices in healthcare facilities |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 9 | Glossary of equivalent standards |
| 11 | Committee representation |
| 12 | Foreword |
| 13 | 1 Introduction and scope 2 Definitions and abbreviations |
| 17 | 3 General recommendations 3.1 Overview 3.2 Focal point for EMC 3.3 EMC and RF wireless technology coordination 3.4 Policies and procedures 3.5 Resources 3.6 Ad hoc immunity testing 3.7 Ad hoc immunity testing (close distance) |
| 18 | 3.8 Coordination of equipment purchase, installation, servicing, and management 3.9 Standards 3.10 Education 3.11 EMI problems 3.12 RF transmitters 3.13 List of RF sources 3.14 RF spectrum usage 3.15 Electronic medical devices used near high-power RF sources 3.16 EMC test reports 3.17 Facility considerations 3.18 “No problem found” 3.19 EMC professionals |
| 19 | 4 Assessment of the electromagnetic environment in existing facilities 4.1 Overview 4.2 Identification of RF sources |
| 21 | 4.3 Identification of areas where critical medical devices are used 4.4 Ambient electromagnetic measurements |
| 22 | 5 Management of the electromagnetic environment 5.1 Overview 5.2 RF spectrum management 5.3 On-site portable and mobile RF sources 5.3.1 General considerations 5.3.2 Categories of RF communications equipment users 5.3.2.1 General considerations |
| 23 | 5.3.2.2 Staff 5.3.2.3 Non-employee emergency and contract personnel 5.3.2.4 General public 5.3.2.5 Patients 5.3.3 Portable and mobile RF source management strategies 5.3.3.1 General considerations 5.3.3.2 Two-way radios |
| 24 | 5.3.3.3 Mobile (cellular and PCS) phones and similar portable wireless equipment 5.3.3.3.1 Balancing the need for communication and EMC 5.3.3.3.2 Usage restrictions 5.3.3.3.3 Total ban of RF wireless technology 5.3.3.3.4 Strategies for low transmission power |
| 25 | 5.3.3.3.5 Communication with user groups 5.3.3.3.6 Equipment relocation, shielding, and filtering 5.3.3.4 Wireless medical and IT equipment 5.3.3.4.1 General considerations |
| 26 | 5.3.3.4.2 Performance of wireless functions 5.3.3.4.3 Wireless coexistence 5.3.3.4.4 Wireless quality of service and data integrity |
| 27 | 5.3.3.4.5 Security of data transmitted wirelessly and wireless network access 5.3.3.4.6 EMC |
| 28 | 5.3.3.5 RFID wireless readers 5.4 On-site fixed RF sources 5.4.1 General considerations 5.4.2 Pager transmitters 5.4.3 Commercial and safety service RF repeaters and cellular and PCS base stations 5.4.4 Outside RF sources 5.4.4.1 Assessment |
| 29 | 5.4.4.2 Analysis |
| 31 | 5.5 Management of unintentional (incidental) sources of RF energy 5.6 Separation-distance considerations |
| 34 | 5.7 ESD mitigation 5.8 AC power distribution system management 5.9 Cable management 6 Management of medical devices for EMC 6.1 Overview 6.2 New medical devices |
| 35 | 6.3 Existing medical devices 6.3.1 General considerations 6.3.2 System mitigation |
| 36 | 6.3.3 Service and maintenance 6.4 Ad hoc RF immunity testing |
| 38 | 6.5 Medical devices for home-care, mobile, and telemedicine use |
| 39 | 6.6 Implantable medical devices 7 Identification, investigation, and reporting of EMI problems 7.1 Overview 7.2 Identification and investigation |
| 40 | 7.3 Reporting |
| 41 | 8 Site selection, design, and construction of facilities 8.1 Overview 8.2 New construction |
| 42 | 8.3 Modifications of existing facilities 8.4 Floor planning 8.5 EMC professional help 9 Education and training 9.1 Overview 9.2 Scope of education and training 9.3 Resources |
| 43 | Annex A Principles of electromagnetic energy and interference mechanisms A.1 Introduction A.2 Coupling of electromagnetic energy A.2.1 General considerations A.2.2 Radiation A.2.3 Conduction A.2.4 Induction A.3 Mechanisms of EMI A.3.1 General considerations |
| 44 | A.3.2 Junction rectification A.3.3 Bit corruption A.3.4 Co-channel, adjacent channel, and intermodulation interference A.3.5 Conducted interference |
| 45 | A.4 Factors affecting the degree of EMI A.4.1 General considerations A.4.2 Frequency and wavelength |
| 47 | A.4.4 Field strength |
| 48 | A.4.5 Absorption and reflection A.4.6 Modulation A.4.7 Device design A.4.8 Device maintenance |
| 49 | Annex B Selected case studies in EMI problems B.1 Introduction B.2 EEG equipment B.2.1 Interference from an elevator relay switching system B.2.2 Interference from a paging system B.3 Dialysis equipment B.4 Ventilators B.4.1 Interference from a two-way radio B.4.2 Interference from cellular telephones |
| 50 | B.5 Infant radiant warmers B.5.1 Interference from FM radio transmissions B.5.2 Interference from two-way radios and cellular telephones B.6 Telemetry patient monitoring systems B.6.1 Interference from a cordless telephone B.6.2 Interference from a fire alarm system |
| 51 | B.6.3 Interference from two-way radios B.6.4 Interference from HVAC relays |
| 52 | B.6.5 Interference from mobile phones B.6.6 Interference from co-channel occupancy B.6.7 Interference from high powered out-of-band signals |
| 53 | B.7 Ultrasound imaging systems B.7.1 Conducted interference from medical devices B.7.2 Conducted interference from AM radio stations B.7.3 Interference because of cabling issues B.8 Other cabling issues |
| 54 | B.9 Interference from electrosurgical units B.10 Interference from ESD B.11 “No problem found” (NPF) |
| 55 | Annex C Model electromagnetic compatibility and RF wireless technology policy and guidance for developing EMC and wireless policies C.1 Introduction C.2 Model policy and guidance |
| 64 | Annex D Overview of surveys of electromagnetic environments associated with healthcare facilities D.1 Introduction D.2 Surveys |
| 65 | D.3 References |
| 67 | Annex E Example of manufacturer declaration of electrosurgical generator meeting IEC 60601-1-2 |
| 71 | Annex F Bibliography F.1 Cited references |
| 74 | F.2 For further reading |
