Medical Device EMC Testing Services
Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.
Medical device manufacturers need to demonstrate compliance with numerous regulations regarding electromagnetic compatibility (EMC), wireless performance, radio frequency (RF) exposure, and other safety and performance requirements to ensure product safety and market entry. UL Solutions provides comprehensive support and guidance from design concept to product completion, helping to avoid potential issues and reduce time to market.
basic information
The conformity of medical devices to EMC has recently become a significant issue, as it can pose a threat to life. If a product does not conform to the intended environment, it becomes difficult to ensure safety compliance and to achieve its intended effects. EMC testing evaluates the potential for interference between nearby products and the risk of injury or damage to people and the surrounding environment. Additionally, these tests assess the compatibility of devices under the intended electromagnetic environment. In many countries, EMC, radio, and radio frequency (RF) exposure and safety requirements are established. For medical products, several standards are set regarding testing, risk management, basic safety, and essential performance. For example, medical devices sold in the United States must comply with IEC 60601-1-2, 4th edition. The IEC 60601-1-2, 4th edition defines the fundamental safety and essential performance of medical devices concerning radiation and immunity to electromagnetic interference. As of the latest information, the U.S. Food and Drug Administration (FDA) has recognized the 4.1 edition as a Recognized Consensus Standard in December 2023.
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UL Solutions provides the necessary EMC testing services to comply with medical device regulations in Japan, the United States, Europe, and other regions. As part of the medical system configuration, testing for information technology equipment (CISPR 32), lighting equipment (CISPR 15), and electric tools (CISPR 14-1) may be required. Additionally, there is an increasing number of medical devices with wireless functions, which necessitates compliance not only with medical device certification but also with the Radio Law of Japan, FCC (United States), and the RE Directive (Europe) as appropriate.
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[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 3: Reprocessing Validation of Medical Devices (ISO 17664)
In diagnosis and treatment, many medical devices come into contact with the human body of patients. This can include contact with healthy skin, as well as contact with wounds or circulating blood and tissues. Naturally, these devices must undergo processes such as cleaning, disinfection, and sterilization to ensure they are in a condition suitable for contact with the human body. Reprocessing of medical devices, including cleaning, disinfection, and sterilization, is often carried out by healthcare institutions. To ensure proper reprocessing, medical device manufacturers are required to provide information regarding reprocessing through user manuals and accompanying documents. In this webinar, we will introduce the items that medical device manufacturers should provide to healthcare institutions regarding the reprocessing process as required by international standards, as well as the specific reprocessing requirements for cleaning, disinfection, and sterilization. We will also discuss lifecycle testing to ensure that reusable medical devices are always safe. Content: 1. ISO 17664 and the reprocessing of medical devices 2. Cleaning 3. Disinfection 4. Sterilization 5. Lifecycle testing
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[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 2: Electromagnetic Interference/EMC Testing for Medical Electrical Equipment (IEC 60601-1-2)
The technical standards targeting medical devices are complex and varied, including the IEC 60601-1 series and individual standards from the IEC 60601-2 series. Additionally, in recent years, revisions have been made to the EMC standards. In this webinar, as part of the introductory series on safety standards for medical devices in 2025, we will provide an overview of IEC 60601-1-2, explain electromagnetic interference testing, and discuss the changes from the 4th edition to the 4.1 edition. We will also introduce some testing methods for basic standards that were requested in last year's survey.
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[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 1: Medical Device Regulations and Safety Standards
We will be holding our popular webinar series on the introduction to safety standards for medical devices again this year, enhancing the content as always. In its third year, this time we will add new themes and incorporate the latest information, providing clear explanations of the overview of standards related to medical devices, as well as safety testing and evaluation points. We encourage you to use this as internal training for those involved in development, regulatory affairs, and quality control at medical device manufacturers. This webinar serves as an introduction to the "Webinar Series on Understanding Safety Standards for Medical Devices from the Basics," where we will introduce the regulations and standards for testing and evaluation related to safety for medical devices in major countries. We will also delve into the standards concerning usability and cybersecurity that will be applicable in Japan in 2024. We hope this will help you understand and prepare the necessary items for testing and evaluation in advance, thereby reducing the burden of applications as much as possible.
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[Medical Device Safety Standards Introductory Seminar 2024] Session 4: Biological Evaluation (ISO 10993-1)
In order to advance the evaluation of biocompatibility required as non-clinical trials in drug applications in various countries, it is necessary to confirm the risks and toxicity of materials used in medical devices, including additives used in their manufacturing processes, and to understand the information for safe use. The revision of ISO 10993-1 in 2018 clarified the positioning of the comprehensive concept of biological safety evaluation, and in drug applications, it has become necessary to understand and practice a comprehensive biological evaluation process rather than merely conducting biocompatibility tests. This seminar will introduce the biological evaluation conducted based on ISO 10993-1, including its objectives, methods, and the biocompatibility tests carried out as part of the evaluation. By attending this seminar, you will be able to understand the regulatory requirements and related standards concerning biocompatibility evaluation, as well as the tests and analyses necessary for toxicity evaluation and their interrelationships. It is expected that a deeper understanding of evaluations and tests will facilitate smoother interactions with regulatory authorities, so please make use of this opportunity.
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[Medical Device Safety Standards Introductory Seminar 2024] Session 2: Electromagnetic Interference/EMC Testing of Medical Electrical Equipment (IEC 60601-1-2)
The technical standards targeting medical devices are complex and varied, including the IEC 60601-1 series and individual standards from the IEC 60601-2 series. In recent years, revisions have been made to EMC standards, and the transition period to the JIS standard JIS T 0601-1-2:2023, issued in February 2023, is approaching in mid-February 2026. In this seminar, as part of the introductory series on safety standards for medical devices in 2024, we will not only provide an overview of IEC 60601-1-2 and an explanation of electromagnetic interference testing but also discuss the changes from the 4th edition to the 4.1 edition of IEC 60601-1-2 in line with JIS T 0601-1-2:2023. You can check the details of the seminar by clicking the "Details & Registration" button below.
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Automatic cutting of product tags and delivery slips, reducing work burden and paper costs [Introduction of cutting machine products and case studies].
How are you cutting invoices, delivery notes, and other types of slips? Are you struggling with the transition from continuous forms to single sheets? With the DUPLODEC cutting machine, whether there are perforations or not, it automatically cuts continuous forms and standard sheets smoothly and efficiently! We also offer products that allow you to in-house perforation processing to reduce paper costs. For more details, please check the product page from the related links below! We also introduce case studies.
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Automatic cutting of product labels and delivery slips, reducing workload and paper costs [Introduction of cutting machine products and case studies].
How are you cutting invoices, delivery slips, and other types of documents? Are you having trouble switching from continuous forms to single sheets? With the DUPLODEC cutting machine, whether there are perforations or not, it automatically cuts continuous forms and standard sheets smoothly and efficiently! We also offer products that allow you to in-house perforation processing to reduce paper costs. For more details, please check the product page from the related links below! We also introduce case studies.
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Introduction of cutting machines for automatic cutting of product labels and delivery slips, reducing work burden and paper costs.
How are you cutting invoices, delivery slips, and other types of documents? Are you struggling with the transition from continuous forms to single sheets? With the DUPLODEC cutting machine, whether there are perforations or not, it automatically cuts continuous forms and standard sheets smoothly and efficiently! We also offer products that allow you to in-house perforation processing to reduce paper costs. For more details, please check the product page from the related links below! We also introduce case studies.
