[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 3: Reprocessing Validation of Medical Devices (ISO 17664)

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

Able to respond to pharmaceutical applications in various countries.

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.

• Public Testing/Laboratory

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

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

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

Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation!

"The 2nd Session: Introduction to Testing and Evaluation Standards for Medical Devices - EMC Testing" is the second installment of a six-part online seminar that explains the overview of standards related to medical devices, as well as safety testing and evaluation points. In this seminar, we will explain the positioning of IEC 60601-1-2 and provide a basic overview of the test plan and risk assessment required by this standard. We will also introduce the changes made in Ed 4.1, which was announced in 2020. We sincerely look forward to your participation. 【Seminar Overview】 ■ Date: February 22, 2023 (Wednesday) 14:00 - 14:40 ■ Participation Fee: Free ■ Content - What is IEC 60601-1-2 - Changes from IEC 60601-1-2 Ed 4.0 to Ed 4.1 - Explanation of the test plan content - What is risk management *For more details, please refer to the related links or feel free to contact us.

• EMC Testing

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

More and more companies are trying to address the increasingly serious shortage of human resources through employee development. However, there are some concerns regarding effective training... ✓ We want to improve the skills of new and existing employees. ✓ There are no instructors or training know-how within the company. ✓ The cost of training is high and does not reach all employees. To address these concerns, "Human Resource Development Professionals, PC Assist Co., Ltd." and "Subsidy Professionals, Social Insurance Labor Consultant Corporation Management Center" will respond! We will thoroughly explain ways to secure human resources while keeping costs down. Please feel free to join us.

ES Waternet Co., Ltd. will exhibit at the 12th International Smart Agriculture Expo held at Makuhari Messe. We will showcase various products including the "Valve Remote Monitoring and Control System OMEGA," which allows for the setting, operation, and monitoring of irrigation programs, including various sensor controls, remotely via PC or smartphone through the cloud; the "Micro Fogger Set," ideal for cooling and humidifying with fine mist in greenhouses and livestock barns; and the "ES Nutrient Cultivation System," which packages automatic irrigation timers, solenoid valves, liquid fertilizer injectors, pressure control valves, air valves, and filters necessary for cultivation in greenhouses. We look forward to welcoming you to our booth.

When conducting structural analysis of organic compounds, IR, NMR, and MS can be considered the three sacred treasures. If the analysis is performed correctly, it is possible to elucidate the structure of even quite complex compounds. However, actual spectra are often not of a single compound, as seen in textbooks, which can lead to significant challenges in interpreting results for beginners in analysis. Additionally, while database searches are a useful tool in structural analysis, the ability to read spectra is necessary to select the correct structure from among the candidates, not just pattern matching. In this course, we will lecture on the basic ways to interpret IR, NMR, and MS spectra, including simple explanations of principles, points to be aware of during analysis, and how to proceed with actual analysis, incorporating some exercises as well.

We will be exhibiting at the "Livestock Materials EXPO" held at Makuhari Messe! We plan to showcase examples of our "Fermentation Drying Equipment for Livestock Manure," provide information on our "Composting Equipment and Deodorants," and introduce our "Subsidy Projects." Please feel free to stop by our booth. We will give a small gift to those who fill out our survey or have implemented our composting system! We look forward to meeting everyone. = Exhibition Information = Dates: October 1 (Wednesday) to October 3 (Friday), 2025, for three days from 10:00 to 17:00 Venue: Makuhari Messe, Halls 5-7, 9, and 10 2-1 Nakase, Mihama-ku, Chiba City Booth Number: Hall 9, 35-6