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 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 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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[Medical Device Safety Standards Introductory Series Seminar 2024] Session 1: Medical Device Regulations and Safety Standards
An introductory seminar on safety standards for medical devices that will be useful to know! This is the 2024 revised edition of last year's highly acclaimed introductory series seminar. We will incorporate the latest information and clearly explain the overview of standards related to medical devices, as well as safety testing and evaluation points in a total of five online seminars. In this seminar, we will introduce the regulatory overview for medical devices in the United States, Europe, and Japan, as well as the standards for non-clinical trials and evaluations required for drug applications. You can check the details of the seminar by clicking the "Details & Registration" button below.
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[Complete 6 Sessions Introductory Seminar] Session 6: Introduction to Testing and Evaluation Standards for Medical Devices – Biological Evaluation in the Respiratory Gas Pathway of Medical Devices (ISO 18562)
Medical devices with "respiratory gas pathways," such as anesthesia machines and ventilators, significantly contribute to our lives in the field of treatment. However, they also carry the risk of introducing harmful particles and chemicals from the outside along with oxygen into the body. ISO 18562 requires testing and evaluation of particles, volatile organic solvents, and condensation that occurs in the pathways of medical devices with respiratory gas pathways, playing a crucial role in ensuring safe use. This seminar will provide a simple introductory overview of the testing and evaluation requirements outlined in ISO 18562. It will also explain the relationship with ISO 10993, which is often considered difficult to understand, and discuss the factors that lead to the generation of particles and chemicals from medical devices. Additionally, we will present the latest trends regarding the ongoing revisions of the standards. You can check the details of the seminar by clicking the "Details & Registration" button below.
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**Overview of UL** UL addresses challenges in safety, security, and sustainability through the application of science, contributing to the creation of a better world. By enabling the safe introduction of advanced products and technologies, UL enhances trust. The staff at UL share a passion for making the world a safer place. From third-party research to standards development, testing, certification, and the provision of analysis/digital solutions, UL aims to build a healthier global society through its operations. The trust in UL supports smart decisions made by businesses, manufacturers, government authorities, regulatory agencies, and individuals. For more details, please refer to the website (UL.com). **Overview of UL Japan, Inc.** UL Japan, Inc. was established in 2003 as the Japanese subsidiary of UL, a global third-party safety science organization. Currently, leveraging UL's global network, it provides conformity assessment services for certification marks required for products in the North American UL mark, as well as safety and EMC certification PSE and S marks based on Japan's Electrical Appliance and Material Safety Law, and certification marks needed for the European and Chinese markets.