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eLibrary > AAMI/ISO TIR10974:2018 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. >

AAMI/ISO TIR10974:2018 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device., 2018

AAMI/ISO TIR10974:2018; Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Title page
Copyright information
AAMI Technical Information Report
ANSI Registration
Contents Page
Glossary of equivalent standards
Committee representation
Background of the AAMI adoption of ISO TS 10974:2018
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for non-implantable parts
6 Requirements for particular AIMDs
7 General considerations for application of the tests of this document [Go to Page]
7.1 Compliance criteria
7.2 Use of tiers
7.3 Test reports [Go to Page]
7.3.1 General
7.3.2 Description of the AIMD under test
7.3.3 Test methods and results
8 Protection from harm to the patient caused by RF-induced heating [Go to Page]
8.1 Introduction
8.2 Outline of the Stage 1 four-tier approach
8.3 Measurement system prerequisites for all tiers [Go to Page]
8.3.1 RF field source
8.3.2 Tissue simulating phantom
8.3.3 Definition of power deposition
8.3.4 Measurement system validation
8.4 Determination of RF-induced power deposition in a tissue simulating medium [Go to Page]
8.4.1 General
8.4.2 Determine location of hot spots around the AIMD
8.4.3 Determination of spatial (3D) distribution of power deposition for each hot spot [Go to Page]
8.4.3.1 General
8.4.3.2 Procedure 1: Numerical assessment with thermal validation
8.4.3.3 Procedure 2: Numerical assessment with SAR validation
8.4.3.4 Procedure 3: Full 3D SAR measurements
8.4.3.5 Procedure 4: Full 3D ΔT measurements
8.4.4 Determine the final power deposition [Go to Page]
8.4.4.1 General
8.4.4.2 Procedure 1: Temperature increase ΔT (if using Procedure 4 from 8.4.3)
8.4.4.3 Procedure 2: SAR (if using Procedure 1, Procedure 2, or Procedure 3 from 8.4.3)
8.4.4.4 Procedure 3: Calibration of point temperature or SAR measurements to total dissipated RF power
8.5 Proximity effect of electrodes from multiple leads
8.6 Modelling prerequisites for Tier 2, Tier 3, and Tier 4
8.7 Tier selection for RF-induced power deposition [Go to Page]
8.7.1 General
8.7.2 Tier 1
8.7.3 Tier 2
8.7.4 Tier 3
8.7.5 Tier 4
8.8 In vitro model validation
8.9 Overall uncertainty analysis
8.10 In vivo analysis of power deposition
8.11 RF-induced heating assessment flow chart
9 Protection from harm to the patient caused by gradient-induced device heating [Go to Page]
9.1 Introduction
9.2 Testing considerations [Go to Page]
9.2.1 General
9.2.2 Determination of |dB/dt| rms exposure limits
9.2.3 Determination of test duration
9.3 Test requirements [Go to Page]
9.3.1 General
9.3.2 In vitro test phantom or other suitable container
9.3.3 Gelled solution
9.3.4 Temperature survey to determine orientation and hot spots
9.3.5 Minimum temperature instrumentation
9.3.6 Definition of dB/dt test waveform [Go to Page]
9.3.6.1 General
9.3.6.2 Tier 1
9.3.6.3 Tier 2
9.3.7 Characterization of applied dB/dt
9.4 Lab testing using simulated MR gradient field
9.5 MR scanner testing
9.6 Analysis of gradient heating test
10 Protection from harm to the patient caused by gradient-induced vibration [Go to Page]
10.1 Introduction
10.2 Overview of tiers
10.3 MR environmental conditions [Go to Page]
10.3.1 General
10.3.2 Determination of maximum clinical dB/dt
10.3.3 Determination of clinical B0
10.3.4 Determination of clinical dB/dt × B0
10.3.5 Test frequencies [Go to Page]
10.3.5.1 General
10.3.5.2 Using a clinical MR scan sequence
10.3.5.3 Using an arbitrary gradient waveform
10.3.6 Test duration
10.3.7 Test temperature [Go to Page]
10.3.7.1 General
10.3.7.2 Room temperature
10.3.7.3 Body temperature
10.4 General test procedure [Go to Page]
10.4.1 Measurement of gradient field and determination of AIMD location
10.4.2 AIMD/test unit setup [Go to Page]
10.4.2.1 Orientation of AIMD in scanner
10.4.2.2 Mounting
10.5 Method 1 — MR scanner
10.6 Method 2 — Shaker table [Go to Page]
10.6.1 General
10.6.2 Determine scanner input
10.6.3 AIMD vibration response [Go to Page]
10.6.3.1 Measurement equipment
10.6.3.2 Measure the AIMD vibration response
10.6.4 Determine shaker table amplitude (dB/dt scaling)
10.6.5 Perform vibration exposure using a shaker table [Go to Page]
10.6.5.1 General
10.6.5.2 Random vibration
10.6.5.3 Profile-driven vibration
11 Protection from harm to the patient caused by B0-induced force
12 Protection from harm to the patient caused by B0-induced torque
13 Protection from harm to the patient caused by gradient-induced extrinsic electric potential [Go to Page]
13.1 Introduction
13.2 General requirements
13.3 Gradient pulse leakage test [Go to Page]
13.3.1 General
13.3.2 Test equipment
13.3.3 Test signal
13.3.4 Tier 1 — Combined gradient-induced charge measurement test procedure
13.3.5 Tier 2 — Separate transient gradient-induced charge and steady-state current measurement test procedure [Go to Page]
13.3.5.1 Gradient-induced charge measurement test procedure
13.3.5.2 Gradient-induced current measurement test procedure
13.4 Gradient rectification test [Go to Page]
13.4.1 General
13.4.2 Test equipment
13.4.3 Test signal
13.4.4 Gradient-induced rectification measurement test procedure
13.5 Gradient pulse distortion of AIMD output test [Go to Page]
13.5.1 General
13.5.2 Test equipment
13.5.3 Test signal
13.5.4 Gradient-induced AIMD output distortion test procedure
14 Protection from harm to the patient caused by B0-induced malfunction [Go to Page]
14.1 Introduction
14.2 Static field testing [Go to Page]
14.2.1 B0 general requirements for static field testing
14.2.2 B0 field generation
14.2.3 Test conditions
14.3 Test procedures [Go to Page]
14.3.1 General
14.3.2 Class 0 test procedure
14.3.3 Class 1 test procedure
14.3.4 Class 2 test procedure
15 Protection from harm to the patient caused by RF-induced malfunction and RF rectification [Go to Page]
15.1 Introduction
15.2 General requirements
15.3 Mechanisms for RF interaction with an AIMD
15.4 Selecting radiated vs injected test methods [Go to Page]
15.4.1 General
15.4.2 AIMD type designation for test method selection
15.4.3 RF antenna type designation for test method selection
15.4.4 RF EMC tier selection
15.4.5 RF test conditions
15.4.6 B0 considerations
15.5 Injected immunity test [Go to Page]
15.5.1 General
15.5.2 Determination of peak and rms injected levels for Tier 1 and Tier 2 — AIMD with short electrical length
15.5.3 Determination of peak and rms injected levels for Tier 3 and Tier 4
15.5.4 Injected immunity test procedure
15.5.5 RF phase test conditions
15.5.6 AIMD monitoring during the test
15.6 Radiated immunity test [Go to Page]
15.6.1 General
15.6.2 Determining the RF radiated field level
15.6.3 Radiated test procedure
15.6.4 AIMD monitoring during the test
15.7 Test equipment [Go to Page]
15.7.1 Generating the RF electric field for radiated testing (AIMD with short electrical length)
15.7.2 Phantom and tissue simulating medium for radiated testing
15.7.3 AIMD monitoring apparatus
15.7.4 RF level measuring device
15.7.5 RF injection network
15.8 Determining the peak RF injected level using a radiated test
16 Protection from harm to the patient caused by gradient-induced malfunction [Go to Page]
16.1 Introduction
16.2 General requirements
16.3 Selecting radiated and injected test methods
16.4 Radiated immunity test [Go to Page]
16.4.1 General
16.4.2 Test equipment
16.4.3 Radiated test signal
16.4.4 Test procedure
16.5 Injected immunity test [Go to Page]
16.5.1 General
16.5.2 Test equipment
16.5.3 Injected test signal
16.5.4 Test procedure
16.5.5 AIMD test configuration [Go to Page]
16.5.5.1 General
16.5.5.2 Group a)
16.5.5.3 Group b)
16.5.5.4 Tissue interface network
17 Combined fields test [Go to Page]
17.1 Introduction
17.2 Test setup
17.3 AIMD fixation
17.4 Test procedure [Go to Page]
17.4.1 General
17.4.2 Before MR exposure
17.4.3 During MR exposure
17.4.4 After MR exposure
17.5 Test equipment [Go to Page]
17.5.1 Field generation
17.5.2 Phantom and tissue simulating medium
17.5.3 AIMD monitoring apparatus
18 Markings and accompanying documentation [Go to Page]
18.1 Definitions
18.2 Applicability of labelling requirements
18.3 Labelling requirements
Annex A (normative) Pulsed gradient exposure for Clause 10, Clause 13, and Clause 16 [Go to Page]
A.1 Pulsed gradient exposure for Clauses 10, 13, and 16
A.2 Determination of dB/dt for AIMD electronics module, electrodes, and extended leads [Go to Page]
A.2.1 AIMD labelled for Fixed Parameter Option
A.2.2 AIMD labelled for maximum gradient slew rate
A.3 Injected voltage determination [Go to Page]
A.3.1 General
A.3.2 Tier 1, Lead length multiplication factor method
A.3.3 Tier 2, Specific AIMD lead loop area method
A.3.4 Tier 3, Electromagnetic simulation method
A.3.5 Model validation for Tier 3
Annex B (informative) Derivation of lead length factor for injected voltage test levels for Clause 13 and Clause 16
Annex C (informative) Tier 1 high tangential E-field trough line resonator [Go to Page]
C.1 Background
C.2 Design Example
C.3 Performance
Annex D (informative) Supporting information and rationale for gradient-induced device heating [Go to Page]
D.1 Rationale for gradient heating |dB/dt| rms [Go to Page]
D.1.1 General
D.1.2 Data survey of clinical MR scanners
D.1.3 Determination of clinical dB/dt exposure limits
D.2 Gradient heating Tier 1 waveform rationale [Go to Page]
D.2.1 General
D.2.2 Waveform type
D.2.3 Magnitude of |dB/dt| rms
D.2.4 Magnitude of BG
D.2.5 Waveform frequency
Annex E (informative) Example RF injection network
Annex F (informative) Supporting information and rationale for MR-induced vibration [Go to Page]
F.1 Explanation of MR-induced vibration
F.2 Tiers: MR scanner vs shaker table
F.3 Clinical scanner vs research scanner
F.4 Potential for AIMD resonance
F.5 Supporting rationales [Go to Page]
F.5.1 Gradient switch mode noise (“Ripple”)
F.5.2 Discussion of location for max dB/dt × B0
F.5.3 Rationale for test frequencies
F.5.4 Rationale for scan duration
F.5.5 Rationale for test temperature
F.6 Vibration measurement equipment consideration
Annex G (informative) Gradient vibration patent declaration form
Annex H (informative) Assessment of dielectric and thermal parameters [Go to Page]
H.1 Introduction [Go to Page]
H.1.1 General
H.1.2 HPM Considerations
H.1.3 LPM Considerations
H.2 Dielectric parameters [Go to Page]
H.2.1 General
H.2.2 Method 1
H.2.3 Method 2
H.2.4 Method 3
H.2.5 Good measurement practices to achieve precise dielectric measurements [Go to Page]
H.2.5.1 General
H.2.5.2 Method 1 (open coaxial probe)
H.2.5.3 Method 2 (slotted line)
H.2.5.4 Method 3 (static conductivity meter)
H.3 Thermal parameters [Go to Page]
H.3.1 General considerations
H.3.2 Methods [Go to Page]
H.3.2.1 Introduction
H.3.2.2 Method to determine heat capacity
H.3.2.3 Method to determine thermal conductivity
Annex I (informative) RF exposure system validation method [Go to Page]
I.1 Objective
I.2 Validation procedure
I.3 Standard test object definitions
I.4 Example SAIMD exposure simulation target values [Go to Page]
I.4.1 General
I.4.2 Example SAIMD-1 target values
I.4.3 Example SAIMD-2 target values
I.5 Test object measurement
I.6 Compare simulation target values to measured results
Annex J (informative) MR scanner RF transmit coil
Annex K (informative) Current distribution on the AIMD as a function of the phase distribution of the incident field [Go to Page]
K.1 Background
K.2 Phase gradients in lossy dielectrics
K.3 Transfer function to determine induced heating
Annex L (informative) Tissue simulating medium formulations
L.1 Rationale
L.2 HPM and LPM Recipes
L.3 Example preparation methods [Go to Page]
L.3.1 General
L.3.2 LPM formulation
L.3.3 PAA HPM formulation
Annex M (informative) Generation of incident fields [Go to Page]
M.1 General
M.2 Background
M.3 Uniform incident field distributions
M.4 Non-uniform incident field distributions
M.5 Pathway modifications
Annex N (informative) Dielectric and thermal tissue properties
Annex O (informative) Gradient field injected testing — AIMD electrode tissue impedance determination method [Go to Page]
O.1 Background
O.2 Theory
O.3 Test setup
O.4 Tissue interface network implementation
Annex P (informative) Estimation of conservative B1 and 10 g averaged E-field values for Tier 1 for RF-induced heating and RF malfunction [Go to Page]
P.1 Objective
P.2 Methods
P.3 Results
P.4 Scaling of results for Tier 1 of RF-induced malfunction
Annex Q (informative) AIMD configuration
Annex R (informative) Electrically excitable tissue stimulation, terms and definitions [Go to Page]
R.1 General
R.2 Stimulation Assessment [Go to Page]
R.2.1 General
R.2.2 Charge duration curve comparison
R.2.3 Strength duration curve comparison
Annex S (informative) Combined fields test [Go to Page]
S.1 Example of MR protocol implementation [Go to Page]
S.1.1 General
S.1.2 Neurological examinations examples
S.1.3 Thoracic examinations examples
S.1.4 Upper limbs examinations examples
S.1.5 Pelvic examinations examples
S.1.6 Lower limb examination examples
S.2 Example of system test configuration
Annex T (informative) General methods for modelling dB/dt levels in MR gradient coils [Go to Page]
T.1 General
T.2 Gradient design methods [Go to Page]
T.2.1 Method of designing single coil
T.2.2 Method of designing different coil axes
T.2.3 Method of designing a set of three gradient axes
T.2.4 Methods of designing the family of 60-cm bore coil designs
T.2.5 Methods of designing the family of 70-cm bore coil designs
T.3 Gradient field calculation methods [Go to Page]
T.3.1 General method for calculating magnetic fields within coils
T.3.2 Region for general magnetic field calculations within coils
T.4 dB/dt calculation methods [Go to Page]
T.4.1 Derivation of dB/dt
T.4.2 Specifics regarding generation of dB/dt table
Bibliography [Go to Page]

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