MRI Compatibility Compliance Services for Passive Medical Devices | Full ASTM Standard Testing | ISO 17025 Accredited Laboratory | Global Regulatory Support for FDA & CE
This service is exclusively designed for passive medical devices (non-electrical, non-powered medical products), covering orthopedic implants, surgical instruments, interventional devices, dental implants, passive fixation devices, and non-metallic medical consumables. We strictly follow the ASTM international MRI safety standard system, and fully comply with global market access requirements including FDA MRI safety guidance and EU MDR regulations.
We provide a full-process service ranging from pre-development material assessment, pre-testing and design optimization, simulation prediction, full ASTM standard compliance testing, regulatory document compilation, labeling compliance to global registration submission. We solve core pain points for manufacturers such as unqualified magnetic displacement, excessive RF heating, image artifact interference, non-compliant labeling, and high multi-market compliance costs, ensuring that passive medical devices meet global MRI safety standards and avoid clinical use and regulatory compliance risks.
All testing and compliance services are implemented in strict accordance with the latest versions of ASTM standards, which are widely recognized and mandatorily adopted by the FDA and regulatory bodies worldwide:
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ASTM Standard No. |
Full Standard Name |
Core Application for Passive Devices |
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ASTM F2052 |
Standard Test Method for Measuring Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
Evaluate the risk of device attraction and displacement in MRI magnetic fields; core safety test item for all passive metallic implants and instruments |
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ASTM F2182 |
Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging |
Exclusively for passive implants; measure temperature rise of devices during MRI scans to prevent thermal injury to patients |
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ASTM F2119 |
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
Quantitatively test distortion and signal loss of MRI images caused by passive devices to ensure accuracy of clinical diagnostic results |
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ASTM F2213 |
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
Evaluate rotational force on passive devices in MRI static magnetic field to prevent device displacement and tissue damage |
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ASTM F2503 |
Standard Practice for Marking Medical Devices for Safety in the Magnetic Resonance (MR) Environment |
Standard specification for MRI safety labels and markings of passive devices; fully compliant with FDA and EU labeling requirements |
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ASTM F2439 |
Standard Guide for Testing Medical Devices in the Magnetic Resonance Environment |
General guidance for full-process testing of passive devices in MRI environment; ensure scientific validity and regulatory compliance of test data |
(1) Exclusive expertise in passive devices: Professional experience in MRI safety evaluation of passive medical devices, with over 100 completed test cases covering orthopedic implants, surgical instruments, interventional devices and other passive device categories.
(2) Full ASTM standard testing capability: Own an ISO 17025 accredited professional MRI testing laboratory, capable of completing all ASTM standard test items in one stop without third-party outsourcing.
(3) FDA-recognized test data: Test reports are fully recognized by the FDA, EU Notified Bodies and global regulatory bodies, and can be directly used for global registration submissions such as 510(k), De Novo, CE MDR.
(4) Pre-development risk control: Break the traditional "develop first, test later" model, provide material selection guidance, magnetic performance pre-evaluation and structure optimization advice in the early design stage to avoid cost waste and cycle delay caused by later design changes.
(5) One-stop full-process compliance: Cover pre-assessment, testing, report issuance, label design, document compilation and registration submission.
(6) Interdisciplinary professional technical team: Composed of MRI engineering experts, material science experts, medical device compliance experts and other professionals; provide precise rectification solutions for unqualified products to ensure one-time test pass.
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Process Stage |
Exclusive Core Service Content for Passive Devices |
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① Pre-Consulting & Material Pre-Assessment |
Demand connection, collection of device material and structure information, magnetic performance analysis of metallic/non-metallic materials, pre-judgment of MR safety classification (MR Safe / MR Conditional / MR Unsafe), issuance of pre-assessment report and compliance roadmap |
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② Customized ASTM Test Plan Formulation |
Develop customized test plan in strict accordance with ASTM standards based on device type, clinical application scenario and target market; clarify test items, field strength parameters, acceptance criteria and delivery cycle |
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③ Pre-Testing & Design Optimization |
Conduct special pre-testing for core risk items such as magnetic displacement, RF heating and image artifacts; provide implementable rectification solutions including material replacement, structure adjustment and geometric optimization to ensure formal test pass rate |
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④ Full Formal ASTM Standard Testing |
Complete all mandatory test items in ISO 17025 accredited laboratory, including magnetically induced displacement force test (ASTM F2052), RF heating test (ASTM F2182), magnetically induced torque test (ASTM F2213), image artifact evaluation (ASTM F2119) |
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⑤ Test Report & Regulatory Document Compilation |
Issue formal and FDA-recognized complete test report; compile MRI safety special content in FDA 510(k) submission materials, EU MDR technical documents and regional regulatory dossiers |
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⑥ Labeling Compliance Service |
Design MR safety labels and warnings in full compliance with ASTM F2503 standard, including classification marks, specified application conditions and multi-language translation adaptation for target markets |
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⑦ Global Registration & Post-Market Support |
Act as manufacturer's authorized representative to connect with global regulatory bodies, submit application materials and answer technical questions; provide supplementary testing for design changes, adverse event tracking and annual compliance review services after launch |
(1) MRI Compliance Solution for Orthopedic Implants: Provide full ASTM standard testing, MR safety classification judgment, design optimization and FDA/CE registration full-process services for spinal implants, joint prostheses, bone plates, screws, intramedullary nails and other orthopedic passive implants.
(2) MRI Compliance Solution for Interventional Passive Devices: Focus on RF heating and magnetic displacement testing under worst-case clinical scenarios for catheters, guidewires, stents, embolic devices and other vascular/interventional passive devices; provide customized testing and compliance services for long-size interventional devices.
(3) MRI Compliance Solution for Dental Implants & Maxillofacial Devices: Provide ASTM standard testing, image artifact evaluation and global market access regulatory support for dental implants, bone graft materials, maxillofacial fixation plates and other oral passive devices.
(4) MR Safe Device Certification Solution: Provide full verification and certification services in accordance with ASTM and FDA standards for non-conductive, non-metallic, non-magnetic passive devices to obtain MR Safe classification, simplifying global registration and clinical use management.
(5) Rectification & Optimization Solution for Test Failure: Provide precise root cause analysis, material replacement, structural optimization and other special rectification solutions for passive devices failing initial ASTM testing; support supplementary testing and document update to ensure rapid compliance.
(6) Global Multi-Market Synchronous Compliance Solution: One set of ASTM test data synchronously complies with requirements of major global markets including FDA, EU MDR, Japan MHLW, Australia TGA; support multi-language label design and multi-regional registration to realize one test for global launch.
ISO/TS 10974 is mainly for active implantable medical devices, while ASTM standards are the most widely used and FDA-mandated test standards for passive medical devices globally. Our services fully align with ASTM standards and can also meet supplementary requirements of ISO/TS 10974 for passive devices.
Only devices composed entirely of non-conductive, non-metallic and non-magnetic materials can be classified as MR Safe, but material verification and document compilation are still required. For non-metallic devices containing trace metal components, the FDA still requires full ASTM testing.
No. RF-induced heating and image artifact characteristics differ significantly between 1.5T and 3.0T MRI systems. ASTM standards and FDA require separate testing for each field strength specified in the device's application conditions.
