Medical Design Briefs - April 2023 - 9

These devices include magnetic, conductive
or metallic materials, and they
have not been proven to be safe under
any condition, as well as those known
to pose hazards in MRI environments.
* MR Conditional. This is applied to devices
that include magnetic, conductive,
or metallic materials. These devices
have been tested and verified to
pose no known hazards in a specified
MRI environment and are accompanied
by labeling that specifies the
conditions of use.
At a minimum, nonactive (passive) implantable
medical devices categorized as
MR Conditional under ASTM F2503 have
been tested for magnetically induced displacement
force (ASTM 2052), magnetically
induced displacement torque (ASTM
F2213), and radio frequency induced heating
(ASTM F2182). Additional testing may
be required, depending on the unique
characteristics of the implantable device.
Reliable Partners for MRI Testing
To fully comply with applicable standards
for MRI testing, manufacturers
should rely on Notified Bodies knowledgeable
about the latest regulatory standards.
TÜV SÜD, for example, is an EU Notified
Body for the review and approval of medical
devices, including implantable medical
devices. The globally active service provider
based in Munich, Germany, has also
been accredited by the IMDRF's Medical
Device Single Audit Program (MDSAP),
which provides a path for demonstrating
compliance with key medical device requirements
in the United States, Canada,
Japan, Brazil, and Australia.
To conduct reliable testing, TÜV SÜD
operates a new medical device testing
facility in New Brighton, MN. The facility
is ISO/IEC 17025:2017 accredited by
the American Association for Laboratory
Accreditation (A2LA) and can test
MRI safety according to ASTM F2052,
ASTM F2213, ASTM F2182, ASTM
F2119, and ASTM F2503.
To support efficient product development,
TÜV SÜD also engages with
many device manufacturers in the early
stages of product design and development.
This enables the experts to test
ROBOTIC END-EFFECTORS
the prototype of the implantable devices
to verify whether or not a product is
on the path to regulatory approval.
This article was written by Mahdi Abbasi,
Global Product Manager - MRI
Safety and Quality Assurance Auditor,
TÜV SÜD Product Service GmbH. He
has more than 14 years of professional
experience as biomedical and electrical
engineer with focus on implantable
medical devices and MRI systems. He
is a quality assurance auditor for ISO
13485, MDSAP, and MDR, as well as a
specialist and business initiator for
MRI safety of active and nonactive
implants. Contact: +49 89 5791 0 or
medicaldevice@tuvsud.com. For more
information, visit www.tuvsud.com/
mri-safety-testing.
TÜV SÜD has recently published a
white paper on ensuring the safety of implantable
medical devices in a magnetic
resonance (MR) environment. It can
be downloaded at https://www.tuvsud.
com/en/resource-centre/white-papers/
safety-of-implantable-medical-devicein-mr-environment.
Measure
all six components of force
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Medical Design Briefs, April 2023
www.medicaldesignbriefs.com
9
http://www.tuvsud.com/mri-safety-testing https://www.tuvsud.com/en/resource-centre/white-papers/safety-of-implantable-medical-device-in-mr-environment http://info.hotims.com/84478-739 http://www.medicaldesignbriefs.com
Medical Design Briefs - April 2023

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