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AAMI TIR18:2010

Current
Current

The latest, up-to-date edition.

GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-08-2010

Glossary of equivalent standards
Committee representation
Foreword
1 Introduction and scope (ALL)
2 Definitions and abbreviations (ALL)
3 General recommendations (ALL)
4 Assessment of the electromagnetic environment
  in existing facilities (TECH)
5 Management of the electromagnetic environment
  (TECH, ADMIN, PSRM, MED)
6 Management of medical devices for EMC (TECH,
  ADMIN, PSRM)
7 Identification, investigation, and reporting of
  EMI problems (TECH, MED, ADMIN, PSRM)
8 Site selection, design, and construction of facilities
  (TECH, ADMIN, HCA)
9 Education and training (ALL)
Annexes
A - Principles of electromagnetic energy and interference
    mechanisms (TECH)
B - Selected case studies in EMI problems (TECH, MED, PSRM)
C - Model electromagnetic compatibility (EMC) and radiofrequency
    wireless technology policy and guidance for developing EMC
    and wireless policies (ADMIN, PSRM, HCA)
D - Overview of surveys of electromagnetic environments associated
    with healthcare facilities (TECH)
E - Example of manufacturer declaration of electrosurgical
    generator meeting IEC 60601-1-2 (TECH, ADMIN, MED)
F - Bibliography (ALL)

Specifies 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.

Committee
EM
DocumentType
Technical Report
ISBN
1-57020-379-2
Pages
78
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

BS EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment
CEI EN 61326-2-6 : 2014 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
AAMI/IEC TIR80001-2-3:2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-3: GUIDANCE FOR WIRELESS NETWORKS
CSA ISO/IEC TR 20017:14 (R2019) Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (Adopted ISO/IEC TR 20017:2011, first edition, 2011-12-15)
ISO/TR 21730:2007 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
PD ISO/TR 21730:2007 Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
10/30216029 DC : 0 BS EN 61326-2-6 - ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT
IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
PD IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices Guidance for wireless networks
IEEE DRAFT 1073.0.1 : D01J 2006 HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - TECHNICAL REPORT - GUIDELINES FOR THE USE OF RF WIRELESS TECHNOLOGY
EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS
ISO/IEC TR 20017:2011 Information technology Radio frequency identification for item management Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators
IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
I.S. EN 61326-2-6:2013 ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV))
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEEE C95.7-2014 IEEE Recommended Practice for Radio Frequency Safety Programs, 3 kHz to 300 GHz
12/30159217 DC : 0 BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
CSA C22.2 No. 60601.1.2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS

EN 302 195-1 : 1.1.1 ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); RADIO EQUIPMENT IN THE FREQUENCY RANGE 9 KHZ TO 315 KHZ FOR ULTRA LOW POWER ACTIVE MEDICAL IMPLANTS (ULP-AMI) AND ACCESSORIES; PART 1: TECHNICAL CHARACTERISTICS AND TEST METHODS
AAMI PC69 : 2007
IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61326-2-3:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-3: Particular requirements - Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning
IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
IEEE/ANSI C63.18-2014 REDLINE American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
IEEE 802.11-2016 IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications
IEC TR 61000-5-2:1997 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 2: Earthing and cabling
ISO/TR 16056-1:2004 Health informatics Interoperability of telehealth systems and networks Part 1: Introduction and definitions
ISO/TR 21730:2007 Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
CISPR 22:2008 Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO/TR 16056-2:2004 Health informatics Interoperability of telehealth systems and networks Part 2: Real-time systems
ESD S20.20 : 2014 PROTECTION OF ELECTRICAL AND ELECTRONIC PARTS, ASSEMBLIES AND EQUIPMENT (EXCLUDING ELECTRICALLY INITIATED EXPLOSIVE DEVICES)
IEEE/ANSI C63.14-2014 REDLINE American National Standard Dictionary of Electromagnetic Compatibility (EMC) including Electromagnetic Environmental Effects (E3)
MIL-STD-461 Revision G:2015 REQUIREMENTS FOR THE CONTROL OF ELECTROMAGNETIC INTERFERENCE CHARACTERISTICS OF SUBSYSTEMS AND EQUIPMENT
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC TR 61000-5-6:2002 Electromagnetic compatibility (EMC) - Part 5-6: Installation and mitigation guidelines - Mitigation of external EM influences
IEC 61000-3-3:2013 RLV Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
IEEE 802.16-2012 IEEE Standard for Air Interface for Broadband Wireless Access Systems
ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
IEC 61326-2-2:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-2: Particular requirements - Test configurations, operational conditions and performance criteria for portable test, measuring and monitoring equipment used in low-voltage distribution systems
IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION
ISO/TR 18307:2001 Health informatics Interoperability and compatibility in messaging and communication standards Key characteristics
IEC 61326-2-1:2012 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-1: Particular requirements - Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications
IEEE/ANSI C63.19-2011 REDLINE American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
IEC TR 61000-5-1:1996 Electromagnetic compatibility (EMC) - Part 5: Installation and mitigation guidelines - Section 1: General considerations - Basic EMC publication
IEC 61000-3-2 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE)

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