PD ISO/TS 10974:2012

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 10g 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 modeling
        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.