ISO TS 10974:2012
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ISO/TS 10974:2012 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who might undergo a magnetic resonance scan in 1,5T, cylindrical bore, whole body MR scanners for imaging the hydrogen nucleus. The tests that are specified in ISO/TS 10974:2012 are type tests intended to be carried out on samples of a device to characterize interactions with the magnetic and electromagnetic fields associated with an MR scanner. ISO/TS 10974:2012 contains test methods that are applicable to a broad class of AIMDs for the purpose of evaluating device operation against several hazards.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$482.63 NZD
|
|
| HardCopy |
$532.13 NZD
|
|
| Networkable PDF |
Price varies
|
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 Protection of patients from potential hazards caused by interactions of the AIMD and MR scanners
8 Test signals
8.1 Gradient sequence of sequences
8.2 RF sequence of sequences
9 General considerations for application of the requirements of this Technical Specification
9.1 Compliance criteria
9.2 Monitoring equipment
9.3 Validation of models and test equipment
9.4 Uncertainty assessment
9.5 Test reports
10 Protection from harm to the patient caused by RF-induced heating
10.1 General
10.2 Outline of the four-tier approach
10.2.1 Tier 1
10.2.2 Tier 2
10.2.3 Tier 3
10.2.4 Tier 4
10.3 Determination of the induced electric and magnetic fields
10.3.1 Electromagnetic simulation
10.3.2 Relevant parameters
10.3.3 Assessment procedure
10.3.4 Uncertainty budget of incident field assessment
10.4 Validation of electromagnetic AIMD models
10.4.1 Validation procedure
10.4.2 Validation criteria
10.5 Generation of incident fields for Tier 1 to Tier 3 and minimal medium requirements
10.6 Measurement system requirements
10.6.1 Probe specification
10.6.2 Validation and characterization of the measurement system
10.7 Procedures and protocols for determination of the distribution and magnitude of the absorbed energy in the tissue equivalent material by SAR and (T measurements
10.7.1 Determination of 3D relative distribution of local energy deposition
10.7.2 Measurement protocol for determination of maximum amplitude
10.8 Uncertainty assessment of energy deposition using SAR or temperature probes
10.9 Compliance criteria
10.10 Test report
11 Protection from harm to the patient caused by gradient-induced device heating
11.1 General
11.2 Testing considerations
11.2.1 General
11.2.2 Determination of clinical dB/dt exposure limits
11.2.2.1 Tier 1
11.2.2.2 Tier 2
11.2.3 Test duration
11.2.3.1 Test duration determination
11.2.3.2 Test duration determined by temperature rise steady state
11.2.3.3 Test duration determined by clinical use condition
11.2.3.4 Test duration determined by labelling constraints
11.2.4 Data collection
11.3 Test requirements
11.3.1 General
11.3.2 In vitro, phantom or other suitable container
11.3.3 Gelled solution
11.3.4 Optical temperature probes
11.3.5 Temperature survey to determine worst-case orientation and hot spots
11.3.6 Minimum temperature instrumentation
11.3.7 Temperature data collection
11.3.8 Monitor applied dB/dt
11.3.9 Gradient field vector orientation relative to device
11.3.10 Monitoring AIMD for heating and malfunction
11.4 Lab testing using simulated MRI gradient field
11.4.1 Simulated field requirements
11.4.2 Pulse waveform RMS value
11.4.3 Gradient sequence of sequences
11.5 MR scanner testing
11.6 Analysis of gradient heating test
11.7 Uncertainty assessment
11.8 Test report
12 Protection from harm to the patient caused by gradient-induced vibration
12.1 General
12.2 General test considerations
12.2.1 Equipment
12.2.2 Determination of clinical dB/dt and B0 exposure limits
12.2.3 Test signals
12.3 Test method for the evaluation of AIMD functionality during exposure to gradient-induced vibration
12.3.1 General requirements
12.3.2 Conducting functional testing using a research scanner
12.3.3 Conducting functional testing using simulated fields
12.3.4 Conducting functional testing using a clinical scanner
12.3.5 Conducting functional testing using a shaker table or other vibration test equipment
12.4 Test method for the evaluation of patient discomfort during exposure to gradient-induced vibration
12.4.1 General requirements
12.4.2 Conducting patient discomfort testing using a research scanner
12.4.3 Conducting patient discomfort testing using simulated fields
12.4.4 Conducting patient discomfort testing using a clinical scanner
12.4.5 Conducting patient discomfort testing using a shaker table or other vibration test equipment
12.5 Test method for the evaluation of risk of tissue injury during exposure to gradient-induced vibration
12.5.1 General requirements
12.5.2 Conducting testing for the evaluation of risk of tissue injury using a research scanner
12.5.3 Conducting testing for the evaluation of risk of tissue injury using simulated fields
12.5.4 Conducting testing for the evaluation of risk of tissue injury using a clinical scanner
12.5.5 Conducting testing for the evaluation of risk of tissue injury using a shaker table or other vibration test equipment
12.6 Uncertainty assessment
12.7 Test report
13 Protection from harm to the patient caused by B0-induced force
14 Protection from harm to the patient caused by B0-induced torque
15 Protection from harm to the patient caused by image artefact
16 Protection from harm to the patient caused by gradient-induced extrinsic electric potential
16.1 General
16.2 Test procedure
16.3 Uncertainty assessment
16.4 Test report
17 Protection from harm to the patient caused by RF rectification
17.1 General
17.2 Test procedure
17.3 Uncertainty assessment
17.4 Test report
18 Protection from harm to the patient caused by B0-induced malfunction
18.1 General
18.2 Test procedure
18.3 Test equipment
18.3.1 Generating the B0 field
18.3.2 Phantom and tissue simulation medium
18.4 Uncertainty assessment
18.5 Test report
19 Protection from harm to the patient caused by RF-induced malfunction
19.1 Introduction of tiered approach
19.2 Injected immunity test
19.2.1 Using the tiers
19.2.2 Test procedure
19.2.3 Test equipment
19.2.3.1 Generating the E-field
19.2.3.2 Phantom and tissue simulation medium
19.2.3.3 RF injection network
19.2.4 Uncertainty assessment
19.2.5 Test report
19.3 Radiated immunity test
19.3.1 Using the tiers
19.3.2 Test procedure
19.3.3 Test equipment
19.3.3.1 Generating the E-field
19.3.3.2 Phantom and tissue simulation medium
19.3.3.3 AIMD monitoring equipment
19.3.4 Uncertainty assessment
19.4 Test report
20 Protection from harm to the patient caused by gradient-induced malfunction
20.1 Introduction of tiered approach
20.2 Injected immunity test
20.2.1 Tier 1
20.2.2 Tier 2
20.2.3 Tier 3
20.2.4 Test procedure
20.2.5 Test equipment
20.2.5.1 Phantom and tissue simulation medium
20.2.5.2 Gradient injection network
20.2.6 Uncertainty assessment
20.2.7 Test report
20.3 Radiated immunity test
20.3.1 Applicability
20.3.2 Tier 1
20.3.3 Tier 2
20.3.4 Test procedure
20.3.5 Test equipment
20.3.5.1 Generating the magnetic field
20.3.5.2 Phantom and tissue simulation medium
20.3.6 Uncertainty assessment
20.3.7 Test report
21 Combined fields test
22 Markings and accompanying documentation
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 2817:1997
Implants for surgery - Care and handling of orthopaedic implants
-
BS 2574-1:1991
Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses
-
BS 2574-2:1994
Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses
-
BS 3531-11:1991
Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs
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 Protection of patients from potential hazards caused by interactions of the AIMD and MR scanners
8 Test signals
8.1 Gradient sequence of sequences
8.2 RF sequence of sequences
9 General considerations for application of the requirements of this Technical Specification
9.1 Compliance criteria
9.2 Monitoring equipment
9.3 Validation of models and test equipment
9.4 Uncertainty assessment
9.5 Test reports
10 Protection from harm to the patient caused by RF-induced heating
10.1 General
10.2 Outline of the four-tier approach
10.2.1 Tier 1
10.2.2 Tier 2
10.2.3 Tier 3
10.2.4 Tier 4
10.3 Determination of the induced electric and magnetic fields
10.3.1 Electromagnetic simulation
10.3.2 Relevant parameters
10.3.3 Assessment procedure
10.3.4 Uncertainty budget of incident field assessment
10.4 Validation of electromagnetic AIMD models
10.4.1 Validation procedure
10.4.2 Validation criteria
10.5 Generation of incident fields for Tier 1 to Tier 3 and minimal medium requirements
10.6 Measurement system requirements
10.6.1 Probe specification
10.6.2 Validation and characterization of the measurement system
10.7 Procedures and protocols for determination of the distribution and magnitude of the absorbed energy in the tissue equivalent material by SAR and (T measurements
10.7.1 Determination of 3D relative distribution of local energy deposition
10.7.2 Measurement protocol for determination of maximum amplitude
10.8 Uncertainty assessment of energy deposition using SAR or temperature probes
10.9 Compliance criteria
10.10 Test report
11 Protection from harm to the patient caused by gradient-induced device heating
11.1 General
11.2 Testing considerations
11.2.1 General
11.2.2 Determination of clinical dB/dt exposure limits
11.2.2.1 Tier 1
11.2.2.2 Tier 2
11.2.3 Test duration
11.2.3.1 Test duration determination
11.2.3.2 Test duration determined by temperature rise steady state
11.2.3.3 Test duration determined by clinical use condition
11.2.3.4 Test duration determined by labelling constraints
11.2.4 Data collection
11.3 Test requirements
11.3.1 General
11.3.2 In vitro, phantom or other suitable container
11.3.3 Gelled solution
11.3.4 Optical temperature probes
11.3.5 Temperature survey to determine worst-case orientation and hot spots
11.3.6 Minimum temperature instrumentation
11.3.7 Temperature data collection
11.3.8 Monitor applied dB/dt
11.3.9 Gradient field vector orientation relative to device
11.3.10 Monitoring AIMD for heating and malfunction
11.4 Lab testing using simulated MRI gradient field
11.4.1 Simulated field requirements
11.4.2 Pulse waveform RMS value
11.4.3 Gradient sequence of sequences
11.5 MR scanner testing
11.6 Analysis of gradient heating test
11.7 Uncertainty assessment
11.8 Test report
12 Protection from harm to the patient caused by gradient-induced vibration
12.1 General
12.2 General test considerations
12.2.1 Equipment
12.2.2 Determination of clinical dB/dt and B0 exposure limits
12.2.3 Test signals
12.3 Test method for the evaluation of AIMD functionality during exposure to gradient-induced vibration
12.3.1 General requirements
12.3.2 Conducting functional testing using a research scanner
12.3.3 Conducting functional testing using simulated fields
12.3.4 Conducting functional testing using a clinical scanner
12.3.5 Conducting functional testing using a shaker table or other vibration test equipment
12.4 Test method for the evaluation of patient discomfort during exposure to gradient-induced vibration
12.4.1 General requirements
12.4.2 Conducting patient discomfort testing using a research scanner
12.4.3 Conducting patient discomfort testing using simulated fields
12.4.4 Conducting patient discomfort testing using a clinical scanner
12.4.5 Conducting patient discomfort testing using a shaker table or other vibration test equipment
12.5 Test method for the evaluation of risk of tissue injury during exposure to gradient-induced vibration
12.5.1 General requirements
12.5.2 Conducting testing for the evaluation of risk of tissue injury using a research scanner
12.5.3 Conducting testing for the evaluation of risk of tissue injury using simulated fields
12.5.4 Conducting testing for the evaluation of risk of tissue injury using a clinical scanner
12.5.5 Conducting testing for the evaluation of risk of tissue injury using a shaker table or other vibration test equipment
12.6 Uncertainty assessment
12.7 Test report
13 Protection from harm to the patient caused by B0-induced force
14 Protection from harm to the patient caused by B0-induced torque
15 Protection from harm to the patient caused by image artefact
16 Protection from harm to the patient caused by gradient-induced extrinsic electric potential
16.1 General
16.2 Test procedure
16.3 Uncertainty assessment
16.4 Test report
17 Protection from harm to the patient caused by RF rectification
17.1 General
17.2 Test procedure
17.3 Uncertainty assessment
17.4 Test report
18 Protection from harm to the patient caused by B0-induced malfunction
18.1 General
18.2 Test procedure
18.3 Test equipment
18.3.1 Generating the B0 field
18.3.2 Phantom and tissue simulation medium
18.4 Uncertainty assessment
18.5 Test report
19 Protection from harm to the patient caused by RF-induced malfunction
19.1 Introduction of tiered approach
19.2 Injected immunity test
19.2.1 Using the tiers
19.2.2 Test procedure
19.2.3 Test equipment
19.2.3.1 Generating the E-field
19.2.3.2 Phantom and tissue simulation medium
19.2.3.3 RF injection network
19.2.4 Uncertainty assessment
19.2.5 Test report
19.3 Radiated immunity test
19.3.1 Using the tiers
19.3.2 Test procedure
19.3.3 Test equipment
19.3.3.1 Generating the E-field
19.3.3.2 Phantom and tissue simulation medium
19.3.3.3 AIMD monitoring equipment
19.3.4 Uncertainty assessment
19.4 Test report
20 Protection from harm to the patient caused by gradient-induced malfunction
20.1 Introduction of tiered approach
20.2 Injected immunity test
20.2.1 Tier 1
20.2.2 Tier 2
20.2.3 Tier 3
20.2.4 Test procedure
20.2.5 Test equipment
20.2.5.1 Phantom and tissue simulation medium
20.2.5.2 Gradient injection network
20.2.6 Uncertainty assessment
20.2.7 Test report
20.3 Radiated immunity test
20.3.1 Applicability
20.3.2 Tier 1
20.3.3 Tier 2
20.3.4 Test procedure
20.3.5 Test equipment
20.3.5.1 Generating the magnetic field
20.3.5.2 Phantom and tissue simulation medium
20.3.6 Uncertainty assessment
20.3.7 Test report
21 Combined fields test
22 Markings and accompanying documentation