ISO TS 10974:2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole body coil excitation.
NOTE 1 Requirements for non-implantable parts are outside the scope of this document.
The tests that are specified in this document are type tests that characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner. The tests can be used to demonstrate device operation according to its MR Conditional labelling. The tests are not intended to be used for the routine testing of manufactured products.
NOTE 2 Modification of these tests for particular device types is left to particular product committees.
NOTE 3 Other interested parties, such as device manufacturers, regulatory agencies, and particular product committees, are responsible for setting specific compliance criteria and determining risk.
NOTE 4 Safety requirements for MR scanners can be found in IEC 60601‑2‑33.
NOTE 5 The scope is limited to AIMDs that do not use sensing functions or to AIMDs that are programmed not to use sensing functions to affect therapy delivery during an MR scan.
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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
7.1 Compliance criteria
7.2 Use of tiers
7.3 Test reports
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
8.1 Introduction
8.2 Outline of the Stage 1 four-tier approach
8.3 Measurement system prerequisites for all tiers
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
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
8.4.4 Determine the final power deposition
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
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
9.1 Introduction
9.2 Testing considerations
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
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
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
10.1 Introduction
10.2 Overview of tiers
10.3 MR environmental conditions
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
10.3.6 Test duration
10.3.7 Test temperature
10.4 General test procedure
10.4.1 Measurement of gradient field and determination of AIMD location
10.4.2 AIMD/test unit setup
10.5 Method 1 — MR scanner
10.6 Method 2 — Shaker table
10.6.1 General
10.6.2 Determine scanner input
10.6.3 AIMD vibration response
10.6.4 Determine shaker table amplitude (dB/dt scaling)
10.6.5 Perform vibration exposure using a shaker table
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
13.1 Introduction
13.2 General requirements
13.3 Gradient pulse leakage test
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
13.4 Gradient rectification test
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
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
14.1 Introduction
14.2 Static field testing
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
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
15.1 Introduction
15.2 General requirements
15.3 Mechanisms for RF interaction with an AIMD
15.4 Selecting radiated vs injected test methods
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
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
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
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
16.1 Introduction
16.2 General requirements
16.3 Selecting radiated and injected test methods
16.4 Radiated immunity test
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
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
17 Combined fields test
17.1 Introduction
17.2 Test setup
17.3 AIMD fixation
17.4 Test procedure
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
17.5.1 Field generation
17.5.2 Phantom and tissue simulating medium
17.5.3 AIMD monitoring apparatus
18 Markings and accompanying documentation
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
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
Annex D (informative) Supporting information and rationale for gradient-induced device heating
Annex E (informative) Example RF injection network
Annex F (informative) Supporting information and rationale for MR-induced vibration
Annex G (informative) Gradient vibration patent declaration form
Annex H (informative) Assessment of dielectric and thermal parameters
Annex I (informative) RF exposure system validation method
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
Annex L (informative) Tissue simulating medium formulations
Annex M (informative) Generation of incident fields
Annex N (informative) Dielectric and thermal tissue properties
Annex O (informative) Gradient field injected testing — AIMD electrode tissue impedance determination method
Annex P (informative) Estimation of conservative B1 and 10 g averaged E-field values for Tier 1 for RF-induced heating and RF malfunction
Annex Q (informative) AIMD configuration
Annex R (informative) Electrically excitable tissue stimulation, terms and definitions
Annex S (informative) Combined fields test
Annex T (informative) General methods for modelling dB/dt levels in MR gradient coils
Bibliography
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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
7.1 Compliance criteria
7.2 Use of tiers
7.3 Test reports
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
8.1 Introduction
8.2 Outline of the Stage 1 four-tier approach
8.3 Measurement system prerequisites for all tiers
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
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
8.4.4 Determine the final power deposition
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
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
9.1 Introduction
9.2 Testing considerations
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
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
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
10.1 Introduction
10.2 Overview of tiers
10.3 MR environmental conditions
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
10.3.6 Test duration
10.3.7 Test temperature
10.4 General test procedure
10.4.1 Measurement of gradient field and determination of AIMD location
10.4.2 AIMD/test unit setup
10.5 Method 1 — MR scanner
10.6 Method 2 — Shaker table
10.6.1 General
10.6.2 Determine scanner input
10.6.3 AIMD vibration response
10.6.4 Determine shaker table amplitude (dB/dt scaling)
10.6.5 Perform vibration exposure using a shaker table
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
13.1 Introduction
13.2 General requirements
13.3 Gradient pulse leakage test
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
13.4 Gradient rectification test
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
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
14.1 Introduction
14.2 Static field testing
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
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
15.1 Introduction
15.2 General requirements
15.3 Mechanisms for RF interaction with an AIMD
15.4 Selecting radiated vs injected test methods
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
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
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
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
16.1 Introduction
16.2 General requirements
16.3 Selecting radiated and injected test methods
16.4 Radiated immunity test
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
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
17 Combined fields test
17.1 Introduction
17.2 Test setup
17.3 AIMD fixation
17.4 Test procedure
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
17.5.1 Field generation
17.5.2 Phantom and tissue simulating medium
17.5.3 AIMD monitoring apparatus
18 Markings and accompanying documentation
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
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
Annex D (informative) Supporting information and rationale for gradient-induced device heating
Annex E (informative) Example RF injection network
Annex F (informative) Supporting information and rationale for MR-induced vibration
Annex G (informative) Gradient vibration patent declaration form
Annex H (informative) Assessment of dielectric and thermal parameters
Annex I (informative) RF exposure system validation method
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
Annex L (informative) Tissue simulating medium formulations
Annex M (informative) Generation of incident fields
Annex N (informative) Dielectric and thermal tissue properties
Annex O (informative) Gradient field injected testing — AIMD electrode tissue impedance determination method
Annex P (informative) Estimation of conservative B1 and 10 g averaged E-field values for Tier 1 for RF-induced heating and RF malfunction
Annex Q (informative) AIMD configuration
Annex R (informative) Electrically excitable tissue stimulation, terms and definitions
Annex S (informative) Combined fields test
Annex T (informative) General methods for modelling dB/dt levels in MR gradient coils
Bibliography