UL Japan List of Products and Services

UL Solutions provides evaluation testing and certification in accordance with product safety standards and EMC standards, biocompatibility testing, reprocessing validation, packaging validation, and ISO 13485 audit registration services to manufacturers of medical devices, in vitro diagnostic medical devices, laboratory equipment, and testing/measurement equipment.

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.

Our company is one of the NRTLs (Nationally Recognized Testing Laboratories) recognized by the U.S. OSHA, and we are also a CB accredited testing laboratory certified by IECEE in the fields of medical electrical equipment and in vitro diagnostic medical devices. Additionally, we are an ILAC accredited testing laboratory registered with the International Accreditation Service, Inc. (USA). The evaluation reports and certifications we provide can be used for medical device and in vitro diagnostic medical device regulatory submissions in various countries.

IEC 62304 (JIS T 2304: Medical Device Software Software Life Cycle Processes) specifies the requirements for the life cycle processes of medical device software and serves as a requirement for obtaining regulatory approval in regions such as Europe, the United States, and Japan. Our company is accredited by the ILAC-accredited organization IAS in the United States for ISO/IEC 17025 certification of IEC 62304 (Medical device software – Software life cycle processes), and you can utilize the 62304 evaluation report with our support.

Medical devices that come into direct or indirect contact with human tissues are required to assess potential biological risks, such as toxicity and allergic reactions. Based on ISO 10993, it is necessary to clarify the contact form with humans, contact duration, characteristics in clinical use, manufacturing processes, physical and chemical properties, and other features, and to conduct appropriate biocompatibility tests for the target devices to evaluate biological safety. UL Solutions provides not only product safety and EMC testing and evaluation services for medical devices based on the 60601 series to comply with regulatory requirements worldwide but also non-clinical testing solutions for medical devices. In UL Solutions' non-clinical testing, we conduct tests on medical devices focusing on biocompatibility and toxicity evaluation for sterilized and non-sterilized, single-use or reprocessed products, as well as E&L (chemical characterization), cleaning, disinfection, sterilization processes, and packaging validation, ensuring safety and efficacy for patients in clinical settings, as well as compliance.

In the field of medical devices, ensuring biological safety with consideration of risk assessment is required, as stipulated in ISO 10993-1. It is necessary to evaluate potential risks, such as toxicity and allergic reactions, to human tissues that come into direct or indirect contact with the medical device. There are various tests, including cytotoxicity tests, irritation tests, sensitization tests, genotoxicity tests, implantation tests, and blood compatibility tests. However, the selection of necessary tests/evaluation items for regulatory compliance must be conducted with consideration of the characteristics of each medical device. ISO 10993-1 categorizes medical devices based on the areas of contact with the human body and the duration of contact, providing endpoints according to the characteristics of the medical device (Table A). However, differences exist among regulatory authorities regarding the recommended testing methods and sample extraction procedures, so it is essential to thoroughly understand these differences. Our company is capable of conducting tests that comply not only with ISO 10993 but also with a wide range of regulations and standards, including FDA guidance, guidelines from the Ministry of Health, Labour and Welfare, USP, and OECD. We also provide toxicological risk assessments in addition to testing.

[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 2: Electromagnetic Interference/EMC Testing of Medical Electrical Equipment (IEC 60601-1-2) March 25, 2025 | Free | Online Technical standards for 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 to EMC standards have been made, and the transition period to the JIS standard JIS T 0601-1-2:2023 is approaching in mid-February 2026. In this webinar, as part of the introductory series on medical device safety standards for 2025, we will provide an overview of IEC 60601-1-2, explain electromagnetic interference testing, and discuss changes from the 4th edition to the 4.1 edition. Additionally, we will introduce some testing methods for basic standards that were requested in last year's survey. For more details and to register, please follow the link below.