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PD ISO/TS 10974:2012

Current
Current

The latest, up-to-date edition.

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-09-2012

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.

Committee
CH/150/2
DocumentType
Standard
Pages
214
PublisherName
British Standards Institution
Status
Current
SupersededBy

Standards Relationship
ISO/TS 10974:2012 Identical

ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEEE C95.3-2002 IEEE Recommended Practice for Measurements and Computations of Radio Frequency Electromagnetic Fields With Respect to Human Exposure to Such Fields, 100 kHz-300 GHz
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
ISO 27186:2010 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
ISO 14971:2007 Medical devices Application of risk management to medical devices

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