[Complete 6-part Introductory Seminar Series] Session 5: Introduction to Testing and Evaluation Standards for Medical Devices – Biological Evaluation (ISO 10993-1)

In addition to the ISO 10993 series, it is possible to comply with FDA guidance, Ministry of Health, Labour and Welfare guidelines, and the United States Pharmacopeia (USP).

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.

• Contract Inspection

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.

• EMC Testing

As an IAS ISO/IEC 17025 accredited testing laboratory for IEC 62304, we provide evaluation services for embedded software.

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.

• Contract Inspection

Compliance with IEC 60601, IEC 61010, and various individual standards.

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.

• Contract Inspection

Providing solutions for the global market.

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.

• Other contract services

In recent years, the implementation of maintenance DX to achieve "non-stop factories" has become an urgent necessity in manufacturing sites. Amid the trend of factory IoT and data utilization, the use of remote I/O, which can remotely aggregate and collect sensor information and control signals from equipment and sensors dispersed inside and outside the factory, is gaining importance as a foundation for predictive maintenance and condition monitoring. On the other hand, the installation environment for remote I/O is not necessarily limited to control panels or well-conditioned factory interiors. There is an increasing need to collect data in harsh environments, such as outdoor equipment and conditions involving high temperatures, low temperatures, vibrations, and strong electrical noise. Conventional remote I/O systems have struggled to operate stably under such conditions, requiring measures like installation location constraints and additional protective enclosures. Environmentally robust remote I/O with wide temperature support and noise resistance can address these challenges, enabling the expansion of the scope of factory IoT and predictive maintenance to outdoor and remote equipment. In this seminar, we will introduce the lineup of Contec's environmentally robust remote I/O, the "CONPROSYS(R) Robust I/O Series," which includes a total of 23 products.

We would like to extend our heartfelt congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will introduce a number of products, including our new product, the Pillow Packaging Full Air Tightness Inspection Machine MSQ-2003. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to visit us at this opportunity. 【 Exhibition Name 】 JAPAN PACK 2025 Japan Packaging Industry Exhibition https://www.japanpack.jp/ 【 Dates 】 October 7 (Tuesday) to October 10 (Friday), 2025 *4 days 10:00 AM to 5:00 PM 【 Venue / Booth Number 】 Tokyo Big Sight / East Hall 8, Booth 8-505

Takaya Corporation will exhibit at the 27th Automatic Identification Comprehensive Exhibition, showcasing the latest RFID solution, "Visible RFID." Exhibition Details: ■ RFID Work Performance Collection System No need for a control PC or dedicated software Autonomous reader compatible with HF and UHF bands Cloud transmission with just an internet connection "Visualization" of work performance on a dashboard Integration with BI tools for "visualization of location" is also possible. ■ Newly developed "Visible RFID" autonomous reader Equipped with an LCD touch panel for on-site performance verification Efficient data management with batch transmission Experience the operability through live demonstrations We will also showcase various other products. Please visit the Takaya booth to experience the latest RFID solutions! We look forward to your visit.

[Lecture Topics] 1. Latest Trends in Information and Communication Policy of the Ministry of Internal Affairs and Communications Kei Yano, Deputy Director, Information and Communications Policy Division, Information and Communications Bureau, Ministry of Internal Affairs and Communications 2. Semiconductor and Digital Policies of the Ministry of Economy, Trade and Industry Tomonari Fujishiro, Chief of the General Affairs Section, Commerce and Information Policy Bureau, Ministry of Economy, Trade and Industry / Chief of the Minister's Secretariat 3. DX Vision of the Ministry of Land, Infrastructure, Transport and Tourism Taisuke Okubo, IT Strategy Planning and Coordination Officer, Information Policy Division, Comprehensive Policy Bureau, Ministry of Land, Infrastructure, Transport and Tourism

[Speaker] Mr. Hideo Sugiura, President and CEO of RSI Co., Ltd. [Key Lecture Content] This seminar will provide a clear explanation of data centers, which are becoming increasingly important as a foundation supporting society and economic activities, from the basics. It will organize the roles of data centers and their fundamental business models, illustrating the background of market expansion and the rising demand. Additionally, it will overview the conditions required for location and buildings, as well as the characteristics of the business, highlighting perspectives that differ from conventional real estate. Furthermore, it will address the latest trends such as the proliferation of AI and the introduction of renewable energy, exploring new entry opportunities and future possibilities across various fields. [Lecture Items] 1. What is a Data Center? - The true nature of the "information infrastructure" that supports society 2. Global and Japanese Market Environment - Trends in rapidly expanding demand and investment 3. Business Models of the Industry - From hyperscalers to colocation 4. Location Conditions and Equipment Requirements - From the perspectives of power, communication, cooling, and security 5. Challenges in the Age of AI - Power, cooling, cost, and carbon-free responses 6. Future Outlook - The future of next-generation digital infrastructure and decentralized data centers 7. Q&A / Business Card Exchange