AAMI ISO TIR 10974 : 2012

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
8 Protection from harm to the patient caused by
   RF-induced heating
9 Protection from harm to the patient caused by
   gradient-induced device heating
10 Protection from harm to the patient caused by
   gradient-induced vibration
11 Protection from harm to the patient caused by
   B[0]-induced force
12 Protection from harm to the patient caused by
   B[0]-induced torque
13 Protection from harm to the patient caused by
   gradient-induced extrinsic electric potential
14 Protection from harm to the patient caused by
   B[0]-induced malfunction
15 Protection from harm to the patient caused by
   RF-induced malfunction and RF rectification
16 Protection from harm to the patient caused by
   gradient-induced malfunction
17 Combined fields test
18 Markings and accompanying documentation
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 B[1] 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

Pertains 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.