Please log in
You must be logged in to send the contact request.
Provide your contact details to the exhibitor. Optionally, you may also add a personal message.
You must be logged in to send the contact request.
Please check your internet connection or try again later.
Your message to the exhibitor was sent successfully.
This company is co-exhibitor of
Business France EPIC
Media files
16.11.2020
Topic
all-day
MRI Safety and Compatibility Assessment
Medical device approval
Labeling
Safety testing
Product category: Medical device approval, Labeling, Safety testing
ISO/IEC 17025 accredited* MRI safety & compatibility testing
ASTM Standards (Passive Medical Devices)
ASTM F2052 Measurement of the displacement force generated by the static magnetic field
ASTM F2213 Measurement of the torque generated by the static magnetic field
ASTM F2182 Measurement of the Radio Frequency induced heating
ASTM F2119 Evaluation of the image artifacts generated by the presence of the device
ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO / TS 10974 (Active Medical Devices)
Clause 8 Assessment of radiofrequency heating
Clause 9 Assessment of gradient field heating
Clause 10 Evaluation of vibrations
Clause 11 Measurement of the displacement force induced by the static magnetic field
Clause 12 Measurement of the magnetic torque induced by the static magnetic field
Clause 13 Assessment of gradient field induced currents
Clause 14 Assessment of malfunctions due to the static magnetic field
Clause 15 Assessment of radio frequency induced malfunctions
Clause 16 Assessment of gradient field induced malfunctions
Clause 17 Assessment of the combined field effects (possibility to monitor implant activity)
Clause 18 Evaluation of the image artifacts generated by the presence of the device
*HEALTIS is ISO/IEC 17025 accredited (accreditation N° 1-6320, scope available on www.cofrac.fr)
Product category: Medical device approval, Labeling, Safety testing
HEALTIS is a leader in evaluating the safety of medical devices introduced in the MRI environment. Our experts participate in the development of standards in the field. This allows us to be at the forefront of knowledge in the evaluation of interactions between MRI and medical devices but also to anticipate changes. Benefit from our expertise through our numerous technical and regulatory assistance services.
Proposed Risk Assessment Strategy
Determination of the worstcases
Writing Rationals
Interpretation of results and marking of the device according to ASTM F2503
Audit of your risk assessment in MRI and proofreading of documents
Product category: Medical device approval, Labeling, Safety testing
Product category: Medical device approval, Labeling, Safety testing
Product category: Medical device approval
Date
Topic
Download
Jul 5, 2020
Healtis adds ISO/TS 10974 B0 Malfunction testing and ASTM F2503 MRI Labelling to our catalog of accredited services
Healtis is pleased to announce that we are now able to offer the following accredited services:
B0 Malfunction testing according to ISO/TS 10974 Clause 14 'Assessment of malfunctions due to the static magnetic field'
MRI Labelling according to ASTM F2503 'Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment'
*HEALTIS is ISO/IEC 17025 accredited (accreditation N° 1-6320, scope available on www.cofrac.fr)
May 13, 2020
Critical Update of Regulatory Standard ASTM F2182
HEALTIS is a MRI Safety and Compatibility laboratory based in Nancy, France; founded in 2012 by Yannick Ponvianne, Cédric Pasquier and Jacques Felblinger.
Since 2012, HEALTIS has acquired a strong recognition for its experience in the field of medical device safety in MRI, focusing on the quality of its services, customer support and the research and development of new activities.
HEALTIS now offers a range of services for medical device manufacturers who want to evaluate the safety of their products in the MRI environment or design an MRI-compatible device:
Recognizing that our work is important to our customers, Healtis has been committed to a consistent quality policy since its inception; to ensure the reliability of our results for our clients.
Website: www.healtis.com
E-mail: info@healtis.com
Tel: +33(0) 970 405 479
* HEALTIS is ISO/IEC 17025 accredited (accreditation N° 1-6320, scope available on www.cofrac.fr)