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.

When shipping wireless-equipped products to countries in the Asia region, it is necessary to meet the regulatory requirements for each destination. These requirements vary significantly due to the radio wave regulations of each country and region, and in recent years, there have been changes to regulations and revisions to the application processes. This seminar will serve as a revised version of the radio wave regulation seminar conducted in 2022 for countries in the Asia region, following up on the previous content while also providing information on the latest trends and regulatory updates. This seminar is intended for those planning to expand their products to various Asian countries, as well as for those who are already operating in the region, providing an opportunity to organize information. Additionally, the second part of the seminar will include the latest trends from major countries outside of Asia. It will also be useful for obtaining the latest information. You can check the details of the seminar by clicking the "Details & Registration" button below.

We will hold an online free technical consultation session regarding medical device safety standards (60601/61010). - "I want to confirm whether the design of the medical device under development complies with the applicable standards." - "I want to check the applicable standards for the medical device under development before requesting an evaluation." - "I want to know the latest status of the 61010-1 standard and individual standards (e.g., EN IEC 61010-2-101:2022/A11:2022, etc.)." - "I want to confirm the available services, estimated costs, required time, necessary documents/samples, and key points for component selection." - "I would like to take this opportunity to ask questions about the requirements of the 61010-1/60601-1 standards." This is recommended for medical device manufacturers who have such questions or challenges. The application deadline is until July 31, so please take advantage of this opportunity. You can check the details of the seminar by clicking the "Details & Application" button below.

ISO 18562 requires testing and evaluation of particulate matter, volatile organic solvents, and condensation that occurs in medical devices with respiratory gas pathways, playing a crucial role in ensuring safe use. This seminar will provide a simple introduction to the testing and evaluation content of ISO 18562. It will be beneficial not only for manufacturers of medical devices that already have respiratory gas pathways but also for those planning to develop such devices in the future. Additionally, there was a revision of the ISO 18562 standard in March of this year, and we will also introduce the key points of that revision. You can check the details of the seminar by clicking the "Details & Registration" button below.

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.

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.

In recent years, the planned abolition of FDA Laser Notice 50 has been announced in the United States, and in Europe, regulations such as EN 60825-1+A11 and EN 50689 have been issued, leading to significant changes in regulations regarding laser products. Do you have any concerns about compliance with safety standards for laser products being shipped to the U.S. or Europe in relation to these regulations and standards? To address such customer inquiries and concerns, we will hold a free individual consultation session regarding compliance with safety standards for laser products. Our experienced specialists from UL Solutions, which has a 130-year history and leads safety science through a global network, will carefully answer your questions and concerns. You can check the details of the technical consultation session by clicking the "Details & Application" button below.

It is important, yet increasingly difficult, to always be aware of the requirements necessary for entering the global market. This document provides the latest standards and regulatory information regarding EMC/Wireless for the United States, Canada, Europe, Japan, and other international standards. Utilize UL Solutions' expertise in global regulations to facilitate rapid entry into your target market and ensure ongoing market access. Overview North America | FCC / ISED Oceania | New Zealand Europe | UK / EU Various Standards | ECC / IEC, etc.

It is important, yet increasingly difficult, to always keep track of the requirements necessary for entering the global market. This document contains the latest standards and regulatory information regarding EMC/Wireless for the United States, Canada, Europe, Japan, and other international standards. Utilize UL Solutions' expertise in global regulations to facilitate rapid entry into target markets and ensure ongoing market access. Overview Japan | Radio Law Europe | UK/EU Various Standards | ETSI / IEC, etc.

On January 16, 2024, OSHA announced the expansion of the Nationally Recognized Testing Laboratory (NRTL) accreditation scope for UL LLC. As part of this expansion, OSHA added 13 testing standards to the NRTL testing standards list. UL 8400 (Standard for Virtual Reality, Augmented Reality, and Mixed Reality Technology Equipment) is one of the added testing standards, applicable to AR/VR/MR headsets used in commercial and industrial environments.

It is important, yet increasingly difficult, to always keep track of the requirements necessary for entering the global market. This document provides the latest standards and regulatory information regarding EMC/Wireless for the United States, Canada, Europe, Japan, and other international standards. Utilize UL Solutions' expertise in global regulations to facilitate rapid entry into target markets and ensure ongoing market access. <Overview> - Japan | Radio Law - North America | FCC / ISED - Oceania | New Zealand / Australia - Europe | EU - Various Standards | ETSI / IECEE, etc. For detailed information and to download materials, please access the "Related Links."

The U.S. FDA has announced that it will abolish Laser Notice 50 regarding laser products by the end of 2024. After 2025, Laser Notice 50 will no longer apply to laser products manufactured, so manufacturers currently adopting this notice will need to take necessary transition measures, such as applying Laser Notice 56, and report to the FDA. Additionally, updates may also be required for UL-certified laser products. UL Solutions will support manufacturers in this regard. For more details, please refer to the article linked below under "Related Links."

In September 2023, ISO 10993-17 was revised for the first time in nearly 20 years. The ISO 10993 series of standards primarily deals with the biological evaluation of medical devices, and ISO 10993-17 specifies the requirements for the assessment of toxicological risks of substances identified through chemical characterization (ISO 10993-18). ISO 10993-17:2023 introduces new terms and concepts such as Toxicological Screening Limit (TSL), Estimated Exposure Dose (maximum; EEDmax), and release kinetics. It also provides a flowchart illustrating how the toxicological risk assessment framework can be integrated into the risk management process for medical devices and toxicological risk assessment reports. For further details, please refer to the "Related Links" below.

UL Solutions has expanded the capabilities of its Ise headquarters safety testing laboratory to provide services compliant with the lease law for consumer products incorporating button batteries or coin batteries, and has started evaluation, testing, and report issuance services to comply with UL 4200A. Compliance with ANSI/UL 4200A can be demonstrated through a letter report provided by UL Solutions. For details on the regulations that will take effect on March 19, 2024, and information about the services, please refer to the "Related Links" below.

IEC 62368-1:2023 (4th edition) was published on May 26, 2023. At this time, the 2nd and 3rd editions are still in circulation, and their adoption varies by country and region. However, standards based on the 4th edition are expected to be gradually adopted in the United States (UL) and Europe, so it is necessary to prepare for the evaluation of the 4th edition. To facilitate a smooth start to the evaluation of the 4th edition, this seminar will explain the main differences between the IEC 62368-1 3rd and 4th editions, based on the guideline document Impact Analysis, by experienced Japanese experts from UL Solutions. You can check the details of the seminar by clicking the "Details & Registration" button below.

We will be holding the "UL Solutions Seminar," which has received great acclaim every year, again this year. This time, we are pleased to welcome Professor Yuji Ikegaya, a brain researcher from the University of Tokyo's Faculty of Pharmaceutical Sciences, as our keynote speaker, who will talk on the theme of "The Future of the Brain and AI." Additionally, we have prepared 15 live seminars that will provide the latest information on standards, regulations, and technologies that are of particular interest across a wide range of fields. Viewing the keynote speech and participating in all live seminars is free of charge. We encourage you to take this opportunity to join us. For details on the 15 live seminars, please check "Details & Registration" or refer to the related materials flyer.

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.

In recent years, we have received many inquiries from manufacturers considering the incorporation of lasers and LEDs into their products regarding the safety of light radiation for the human body and compliance with regulations in the countries where they sell their products. We will hold a consultation meeting as an opportunity to address various concerns and questions that manufacturers may have regarding regulations and standards. You can check the details of the seminar by clicking the "Details & Registration" button below.

On September 2, 2022, the Ministry of Internal Affairs and Communications partially revised the Radio Law Enforcement Regulations, finally allowing the 6GHz band to be opened in Japan, enabling the use of approved Wi-Fi 6E compatible products within the country. Additionally, as regulatory frameworks in various countries advance, inquiries from manufacturers considering future overseas expansion are increasing. This seminar will provide the latest regulatory information from major countries in Asia, the Middle East, and Latin America as a second installment following the first installment, "Latest Regulatory Information on Wi-Fi 6E Compatible Products in Japan, North America, and Europe." By obtaining the latest information from each country, participants can utilize it for future expansion plans and development reviews. <Content> - Asia regulatory information (South Korea, Thailand, Malaysia) - Middle East regulatory information (Qatar, Kuwait, UAE, Saudi Arabia) - Latin America regulatory information (Mexico, Argentina, Brazil), etc. - Information provision service Details of the seminar can be confirmed by clicking the "Details & Registration" button below.

An overview of medical device regulations and key points of safety testing and evaluation! This is the fourth 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 modern medicine, many medical devices are powered by electricity. These devices come into contact with patients during diagnosis and treatment processes. The contact occurs on the body surface or inside the body, exposing patients to potential dangerous situations such as electric shock or burns. IEC 60601-1 specifies the "basic safety" and "essential performance" necessary for medical devices (medical electrical equipment) to be used safely and effectively on patients. This seminar will explain the definitions of terms used in the standards, the regulatory framework including related subordinate regulations, risk management, usability engineering, programmable electrical medical systems, as well as requirements regarding protection against electric shock and burns for operators and patients, and testing requirements. We aim for participants to understand the key points of IEC 60601-1 and to visualize its overall framework. You can check the details and agenda of the seminar by clicking the "Details & Registration" button below.

Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation! This is the third installment of a six-part online seminar that explains the overview of standards related to medical devices and key points of safety testing and evaluation. ---- Session 3: Introduction to Testing and Evaluation Standards for Medical Devices – Cybersecurity In 2021, IEC 81001-5-1, a lifecycle standard for ensuring the safety, effectiveness, and security of healthcare and health IT systems, including medical devices, was issued. Major regulatory authorities, including the International Medical Device Regulators Forum (IMDRF), began issuing guidance for addressing cybersecurity in medical devices. In this seminar, we will explain the overview and noteworthy requirements related to cybersecurity, focusing on IEC 81001-5-1, which medical device manufacturers should consider when addressing cybersecurity. This is an opportunity to deepen your understanding of cybersecurity, which is also gaining attention in regulatory frameworks in Japan, the United States, and Europe, through a comprehensive approach across the product lifecycle.

On September 2, 2022, the Ministry of Internal Affairs and Communications partially revised the Radio Law Enforcement Regulations, finally opening the 6GHz band in Japan, allowing the use of approved Wi-Fi 6E compatible products within the country. However, the use of Wi-Fi 6E must meet the regulatory requirements of each country and region. This seminar will serve as the first installment explaining the latest regulatory information for Wi-Fi 6E compatible products, providing updates on Japan, North America, and Europe, as well as basic knowledge about Wi-Fi 6E and differences in testing content compared to previous standards. We hope this will be useful for your future development and testing preparations, as well as cost estimations. Additionally, the second installment of the seminar is planned to cover the latest regulatory information from countries outside of Japan, North America, and Europe, so please look forward to that as well. Those who register for this seminar will receive further information. You can check the details and agenda of the seminar by clicking the "Details & Registration" button below.

As a global leader in safety science, UL Solutions (headquartered in Northbrook, Illinois) will add two 3-meter anechoic chambers at the Shonan EMC Laboratory to meet the growing demand and cutting-edge wireless technology. UL Solutions will expand the laboratory's capacity in the field of advanced wireless testing, including Wi-Fi 6E, contributing to a reduction in time-to-market for manufacturers in response to increasing demand. Additionally, by introducing the latest system for Specific Absorption Rate (SAR), which indicates the amount of exposure to the human body, UL Solutions will be able to provide the latest SAR testing services compliant with various global standards, including those from Europe, the FCC (Federal Communications Commission), and ISED (Innovation, Science and Economic Development Canada).

Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation! This is the second installment of a six-part online seminar that explains the overview of standards related to medical devices and key points of safety testing and evaluation. ---- Session 2: Introduction to Testing and Evaluation Standards for Medical Devices - EMC Testing Technical standards for medical devices include individual standards from the IEC 60601-1 series and the IEC 60601-2 series, which are diverse and complex. In recent years, revisions to EMC standards have also been made. In this second session of the introductory series on safety standards for medical devices, 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 discuss the changes made in Ed 4.1, which was announced in 2020. You can check the details and agenda of the seminar by clicking the "Details & Registration" button below.

Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation! This is the first installment of a six-part online seminar that explains the overview of standards related to medical devices and key points of safety testing and evaluation. ---- Session 1: Introduction to Medical Device Regulatory Compliance - Overview of Domestic and International Regulations and Introduction to Related Testing Standards In the regulatory submission for medical devices, it is required to demonstrate safety in use through multiple tests and evaluations applicable as non-clinical trials. However, conducting tests and evaluations in each field necessitates a deep understanding of the related standards, which can be time-consuming in preparing the submission. Additionally, standards are constantly updated with new versions and releases, requiring medical device manufacturers to invest effort in compliance. This seminar will explain the regulatory overview of medical device submissions in the United States, Europe, and Japan, and introduce the relevant testing and evaluation standards associated with medical device regulatory submissions. You can check the details and agenda of the seminar by clicking the "Details & Registration" button below.

We will hold the "UL Solutions Seminar," which has received great acclaim every year, again this year. This time, in addition to a keynote speech titled "Reverse Time Machine Management Theory" by Ken Kusunoki, the author of "Competitive Strategy as Story," you can also view 13 latest topic seminars on the latest standards and regulations presented by our experts for free. For more details, please check the PDF or "Details & Application." 【Introduction to Live Seminars (Partial)】 ■ November 15, 2022 (Tuesday) 14:00 - 14:45 Overview of IEC 60601-1 Third Edition Amendment 2 ■ November 24, 2022 (Thursday) 14:00 - 14:50 Trends in battery standards, testing, and regulatory information from various countries ■ November 29, 2022 (Tuesday) 14:00 - 15:00 Acceptance trends of IEC 62368-1 in various countries and recent key topics, trends of IEC 62368-1 Fourth Edition ■ November 30, 2022 (Wednesday) 14:00 - 16:00 Latest trends in radio laws in various countries, focusing on Europe (EU/UK), North America, and Japan

We will hold an online tour to introduce the Reverberation Chamber (RVC), which will start operations in October 2022. Even for customers who find it difficult to visit the site in person, you can view the expanded Automotive Technology Center online. In addition to the RVC, we will also introduce the EHV Chamber, which is a fixed-dynamo equipped anechoic chamber. In the automotive industry, there is a demand for quick responses to changes in the environment and regulations surrounding vehicles. The UN ECE Regulation has introduced the RVC method, which is closer to real-world conditions compared to the traditional ALSE method (Antenna Radiation Method). The RVC can generate a uniform electric field in the anechoic chamber, allowing for tests that simulate the electromagnetic environment of urban areas where vehicles are actually used. We hope you take this opportunity to view our new facility.

As many automotive parts are now electronically controlled, the automotive industry has begun to emphasize the implementation of EMC tests that simulate actual usage environments from the perspective of quality assurance. In accordance with UN ECE Regulation, the RVC method, which is closer to real-world conditions compared to the traditional ALSE method (Antenna Coupling Method), has been introduced. To quickly respond to changes in standards, UL Solutions has expanded its Automotive Technology Center and introduced a Reverberation Chamber (RVC), which will be operational starting in October. To commemorate the operation of the RVC, we will hold an open house, and we encourage you to apply for this opportunity. For details about the open house and how to apply, please check "Details & Application."

UL Solutions, a global leader in safety science, is enhancing safety testing services in Japan and supporting the mobility industry's response to connected, autonomous, shared, and electrified (CASE) technologies. As many automotive components become electronically controlled, the automotive industry has begun to emphasize the importance of conducting EMC tests that simulate actual usage environments for quality assurance. In line with UN ECE Regulation, the RVC method, which is closer to real-world conditions compared to the traditional ALSE method (Antenna Coupling Method), has been introduced. To quickly respond to changes in standards, UL Solutions will expand its Automotive Technology Center and implement a Reverberation Chamber (RVC). By introducing the RVC, it will be possible to generate a uniform electric field within the anechoic chamber, allowing for tests that simulate electromagnetic environments similar to urban areas where various electromagnetic waves coexist. This will enable reliable EMC testing that meets the rapid electronic control demands of modern vehicles. Additionally, with the introduction of the RVC, UL Solutions will also comply with EMC testing standards RTCA DO-160G and MIL-STD-461G for electronic devices installed in both civilian and military aircraft.

Since 2017, certification by the South African Bureau of Standards (SABS) has begun, and submission of test reports issued by SABS accredited laboratories and obtaining certification are required. This document answers frequently asked questions from customers in a Q&A format based on confirmations with the SABS authorities. We hope this will be helpful for a smooth product introduction into the South African market.