In the biological evaluation of medical devices, compliance with ISO 10993 is required, and among them, medical devices with a respiratory gas pathway are subject to ISO 18562. With the revision of ISO 10993-1 in 2018, the importance of biological evaluation based on biocompatibility risk has increased not only in Europe and the United States but also in Japan. For medical devices with a respiratory gas pathway, the 2020 version of ISO 18562 has been issued, and inquiries regarding the relationship with ISO 10993 have also been increasing. In this seminar, we will explain the relationship between ISO 10993 and ISO 18562, as well as an overview of the tests required by the structure of ISO 18562. Additionally, we will introduce related services provided by UL. --------- Target Audience: - Regulatory affairs personnel from manufacturers of medical devices with a respiratory gas pathway - Individuals considering conducting biocompatibility evaluations for medical devices - Those interested in ISO 18562

We will hold the highly acclaimed "UL Seminar" online this year as well. This year, in addition to a keynote speech by Ken Shibusawa titled "Opening the Future with Eiichi Shibusawa's 'Analects and Abacus' - A Sustainable Society and Corporate Management in the Post-Corona Era," we have prepared approximately 20 new seminars that will provide the latest standards, regulations, and technical information in fields of particular interest within domestic industries. Registration is free. Please take this opportunity to sign up. For details about the seminar, please check the link.

【Due to high demand, now available on demand】The standards required for compliance when exporting products to Mexico vary by product. As of June 2021, there are some differences in the application methods and the materials you need to prepare for NOM-001-SCFI-2018 and NOM-019-SCFI-1998. Additionally, after obtaining certification, an annual market surveillance is required, which differs from UL's factory inspection. This on-demand seminar will introduce the application procedures for these standards and the materials needed for the application. By attending this seminar, you will be able to confirm whether your products fall under NOM-regulated items, understand the necessary preparations for a smooth application process, and learn about the post-application requirements. We will also provide information on product labeling requirements, which are often a source of questions, so please take this opportunity to participate. Target Audience: - Those considering shipping to Mexico - Those considering NOM applications - Those wanting to organize information regarding NOM applications - Those with questions about product labeling requirements for NOM applications This on-demand seminar is a recorded version of the online seminar held in July.

【Due to high demand, it has become an on-demand seminar】 Medical devices that come into direct or indirect contact with patients are required by regulatory authorities in various countries to conduct biocompatibility evaluations in accordance with ISO 10993-1. With the revision of ISO 10993-1 in 2018, it has become necessary not only in Europe and the United States but also in Japan to establish a Biological Evaluation Plan (BEP) based on biocompatibility risks before conducting biocompatibility tests and to properly execute the plan. In this seminar, we will convey a systematic approach to biocompatibility evaluation, introduce the challenges and factors that influence biocompatibility assessment, and outline the basic structure of the Biological Evaluation Plan (BEP). Target Audience: - Personnel responsible for medical device regulatory affairs - Those considering conducting biocompatibility evaluations for medical devices - Individuals interested in the Biological Evaluation Plan (BEP) This on-demand seminar is a recorded version of the online seminar held in July.

[Free On-Demand Seminar] Brazil/ANATEL issued Act No. 77 on January 5, 2021, adding cybersecurity requirements for telecommunications equipment (composed of approximately 40 security requirements). As a result, starting from July 4, 2021, it became necessary to submit a declaration regarding cybersecurity as part of the application documents for telecommunications equipment connected to the internet or communication lines. Applicants must demonstrate that their products meet security requirements and adequately address vulnerabilities by submitting this declaration. This seminar will provide information on the cybersecurity requirements added to Brazil's radio law regulations by Act No. 77. These requirements include not only security demands for the products themselves but also requirements related to addressing security vulnerabilities in the market. It is anticipated that similar regulations will emerge in other countries in the future, which will help in understanding the security regulatory requirements for wireless communication devices. Target Audience: - Those considering shipping wireless-enabled products to Brazil - Those who want to obtain the latest information on Brazil/ANATEL's radio law regulations.

[Free On-Demand Seminar] The incorporation of electronic devices for control, communication, and other functions in earthmoving and construction machinery has been increasing. To improve electromagnetic compatibility in these machines and align with international standards, JIS standards have been issued. In this seminar, following the overview and guidance on testing and certification of the "EMC Standard for Construction Machinery EN ISO 13766," we will provide information on the domestic standard "JIS A 8316 -1/-2," including the process leading to JIS standardization, its overview, recommended testing at the machine unit level in JIS A 8316, and trends in Europe and other countries. <Target Audience> - Manufacturers of earthmoving and construction machinery - Individuals involved in the design and manufacturing of earthmoving and construction machinery - Individuals involved in the design and manufacturing of components to be incorporated into earthmoving and construction machinery - Those who wish to deepen their understanding of the new standards JIS A 8316 -1/-2 - Those who want to confirm the overview of EMC regulations - Those considering EMC testing for earthmoving and construction machinery or looking for testing facilities

Free | About 10 minutes The UL standards for printed circuit boards have been revised, and a standardized reflow profile (temperature/time intended for surface mounting) for solder limits has been introduced. The UL certification for printed circuit boards is a conditional certification, and the solder limit is one of the important certification conditions for printed circuit boards. This presentation will briefly explain the background of the introduction of the standardized reflow profile and future responses for those obtaining certification for printed circuit boards and those using printed circuit boards in final products.

In recent years, the services of 5G, the next-generation communication standard, have been gaining momentum with the sale of 5G-equipped smartphones, the launch of local 5G services, and major carriers planning to sequentially start commercial services after March 2020. 5G is characterized by ultra-high speed, ultra-low latency, and a large number of simultaneous connections, making it essential for promoting IoT, such as in autonomous driving of vehicles, smart factories, and revitalizing the entertainment sector. There are high expectations for expansion and innovation not only in traditional communication fields but also in new areas and services. However, there are also concerns about the effects of 5G on the human body, and it is becoming increasingly important to conduct human exposure tests to determine whether electromagnetic waves emitted by communication devices such as smartphones, laptops, and GPS trackers have adverse effects on human health. In Japan and around the world, there is a growing demand for human exposure tests for portable wireless devices, and human exposure tests for 5G will be an unavoidable requirement for the future spread of 5G. In this seminar, we will explain not only SAR but also power density measurements necessary for 5G millimeter-wave compliance, and further introduce the testing services we provide.

On September 1, 2020, the Ministry of Internal Affairs and Communications announced the results of the public consultation regarding the "Guidelines for Terminal Equipment Standards Certification based on the Telecommunications Business Act (2nd Edition)" (draft) and published the guidelines. This includes additional content regarding the handling of security certification for incorporated modules due to the passage of the enforcement date, as well as the organization of the concept of the responsibility boundary for sXGP digital cordless telephones, which was published on April 22, 2019, in the "Guidelines for Terminal Equipment Standards Certification based on the Telecommunications Business Act (1st Edition)." In this seminar, we will explain the following topics in accordance with the guidelines (2nd Edition): - Conditions for whether or not to meet the newly established security standards - Details regarding security standard certification, including specific testing methods and necessary application documents - The responsibility boundary for self-operated digital cordless telephones sXGP - The relationship between wireless LAN devices and Bluetooth devices concerning the presence of logo certification and technical compliance certification.

In April 2019, we established a reliability testing laboratory and began conducting reliability tests (environmental tests and durability tests) for automotive equipment as required by international standards and the unique standards of domestic and international automobile manufacturers. To further enhance our services for automotive equipment and to respond to the rapidly increasing demand for reliability testing of mobility components, we expanded the reliability testing laboratory within our headquarters in Ise City, Mie Prefecture, and commenced operations on September 1, 2020. In this virtual lab tour, you can view the expanded lab online. You can check not only the performance and functions of the equipment but also the spacing and arrangement of the devices, just like in an actual on-site lab tour.

If you have imported or sold wireless devices such as Bluetooth and WLAN that have undergone conformity assessment under ETSI EN300 328 in the past, please be sure to watch this. The current standard will be withdrawn in August 2021. (Free | Video duration: approximately 19 minutes | Language: Japanese) In July 2019, the standard ETSI EN300 328 V2.2.2 concerning the radio emission characteristics of wideband communication devices in the 2.4 GHz band was issued. The current standard V2.1.1 will be withdrawn on August 6, 2021, and if products that have previously undergone conformity assessment continue to be shipped, it will be necessary to update to V2.2.2. We will explain the changes from V2.1.1. Target audience: - Those who have previously applied ETSI EN 300 328 for conformity assessment - Those engaged in the planning, design, manufacturing, and sales of products equipped with wireless technologies such as Bluetooth and WLAN.

In recent years, many products have been equipped with Bluetooth technology, and the importance of Bluetooth SIG certification (logo certification), which is a mandatory requirement, is increasing. At UL Japan, our staff, including Bluetooth Qualification Consultants (BQC) with extensive experience and achievements, provide comprehensive support from preliminary meetings to obtaining Bluetooth SIG certification and compliance with various national radio laws. This seminar will clearly explain the basics of SIG certification. You will understand the key points regarding the SIG certification flow and the necessary documents for obtaining SIG certification.

In Japan, wireless products are regulated by the Radio Law. Manufacturers and importers must carry out necessary procedures along with confirming compliance with technical standards when selling or importing wireless products in Japan. This seminar will explain the requirements and procedures for radio certification in a way that is understandable for those who are handling it for the first time, covering the basics such as the application process, necessary documents for the application, test samples, and test items.

In Japan, commercial 5G services began in March 2020, marking the arrival of the full-fledged 5G era. In this seminar, we will introduce an overview and trends of 5G, as well as the necessary tests and certifications for products equipped with 5G, and further, we will present the certification and testing services we offer.

In recent years, the demand for wireless and EMC testing has surged due to the wirelessization of products, the electrification and EV transition of automobiles, and the electronicization of onboard devices. As it has become urgent to conduct conformity tests for the necessary standards, we have launched a virtual witnessing test service to make conformity testing more accessible. Traditionally, in witnessing tests, customers would visit the testing facility to set up the tests and confirm the operation of the test devices. However, with the virtual witnessing test, customers can now participate in the witnessing tests from their own devices by combining various cameras, such as smart glasses, with a teleconferencing system. Additionally, we will also introduce applications for commissioned testing, not just witnessing tests.

The amendment to the Ministerial Ordinance of the Telecommunications Business Act and the Terminal Equipment Regulations has been made, and a new "Security Standard" has been established. This new regulation differs in nature from the previous ones, and guidelines regarding it have also been published. The new regulations will come into effect on April 1, 2020. UL Japan has already begun multiple certifications. In this seminar, we will clearly explain the overview of the Telecommunications Business Act and provide more specific content in line with the guidelines.

The increasing trend in the reliability evaluation testing market can be attributed to the recent advancements in electrification and digitalization, which have led to an increase in components and, consequently, an increase in testing itself. Additionally, the growing adoption of new materials such as resin and composite materials is also a factor contributing to the rise in testing. Among these, automotive electronics components are particularly noted for their growing demand, as they are exposed to harsh environments such as temperature and humidity changes, vibrations, heat, water, and dust, necessitating testing under various conditions to ensure proper functionality. The adoption of new components leads to a greater number of parts, which in turn increases the number of testing items. Furthermore, for automotive manufacturers, parts manufacturers, and material manufacturers conducting tests, the investment required to maintain the latest testing equipment in-house for each increasing component and new material becomes a significant burden. As a result, there has been an increase in cases where reliability evaluation tests are outsourced to external testing laboratories. In light of this situation, our company is enhancing and expanding specialized and advanced testing facilities to meet the new testing demands.

In the United States, there are safety regulations regarding radiation exposure for products equipped with lasers. Manufacturers need to confirm compliance with safety standards and complete the necessary procedures with the authorities when importing and selling laser products in the U.S. This seminar will explain the safety standards required and the procedures to be followed with the authorities when launching products in the U.S. market.

UL will hold an on-demand seminar on the increasingly in-demand topic of cybersecurity. In this seminar, we will provide the latest information on cybersecurity and compare the mainstream security standards and frameworks. In recent years, products connected to the internet, both wireless and wired, have become widespread, and at the same time, the risks associated with cybersecurity have also increased. You may have noticed an increase in keywords such as "system holes," "vulnerabilities," and "cyber attacks." Various countries, regions, and technical organizations have developed and published their own security regulations, standards, and frameworks, leaving many customers unsure about which to apply. This seminar will provide the latest information on cybersecurity regulations and compare the mainstream security standards and frameworks. We will also introduce two main security services developed and provided by the third-party safety science organization UL. Watch here: https://connect.ul.com/Cyber-security_LP-Register.html

Since its development in the 19th century, batteries have been widely used and have become indispensable in cutting-edge products of the times, such as mobile devices and electric vehicles. While the size, types, and energy densities have diversified, the demand for safe usage of batteries has remained constant. Safety standards have been adopted globally as mechanisms that contribute to the safety of batteries. In this seminar, we will broadly introduce safety standards related to batteries. Focusing on international standards and UL standards, we will provide an overview of each standard and their applications, enabling a comprehensive understanding of the diverse battery standards.

Including Japan, approximately 140 countries/regions around the world have established legal regulations (Radio Law) for the market launch and use of devices equipped with wireless functions. In the current IoT era, various new products are being equipped with wireless capabilities, but compliance with the Radio Law is required in their export, import, and market launch plans. The regulations of the Radio Law vary by country, and it currently takes time and effort to understand the regulations and obtain the necessary approvals. This seminar will provide fundamental information that those involved in Radio Law applications for the first time should understand when considering obtaining Radio Law certification. We hope this will be the first step in deepening your understanding to obtain Radio Law approval in the countries where you wish to export your products. Additionally, this seminar is a renewal of a highly praised seminar that has been held since 2018. As additional content, we have included explanations regarding procedures for factory changes and production at multiple factories, as well as a section to answer questions from participants about the latest regulatory trends.

When shipping wireless-equipped products to countries in Latin America, it is necessary to meet the regulatory requirements of each country. These requirements vary significantly due to the radio wave regulations of each country, and in recent years, there have been changes to regulations and revisions to the application process. In this seminar, following the previous session on major Asian countries, we will provide guidance on the radio wave regulations of Latin American countries in the first part. Based on our application and research experience in 200 countries/regions, we will cover the application procedures for radio wave laws, points to note during applications, and regulatory trends based on the latest research results, so please take this opportunity to organize your information. In the second part, we also plan to include the latest information on countries with recent regulatory changes that have received many requests for explanation, such as Indonesia (radio wave law) and South Africa (EMC regulations). This will also be useful for obtaining the latest information. Content: Part 1: Radio Wave Laws of Latin American Countries - Points to Note and Latest Trends - Brazil - Argentina - Chile - Mexico Part 2: Latest Information on Changes in Radio Wave Laws and EMC Regulations - Indonesia Radio Wave Law (tentative) - South Africa EMC Regulations (tentative)... and more.

In recent years, laser technology has been adopted in many products beyond traditional barcode readers, DVD/CD drives, and laser printers, including laser projectors, laser lighting, 3D LiDAR/Time-of-Flight (TOF) sensors, head-up displays (HUD), and 3D printers. Our experienced engineers are available for direct consultations regarding questions about laser safety standards such as IEC/EN 60825-1 and US 21CFR Part 1040, as well as inquiries about laser product notifications to the US FDA. We also welcome consultations on topics such as: - I have heard the keyword "laser safety," but I don't understand what it entails. - I want to know what points to be careful about when exporting laser products overseas for the first time. - I would like to consult whether the product I am developing is designed to comply with laser safety standards. - I want to know about the FDA procedures and requirements that are necessary when exporting to the US. - I would like to clarify any uncertainties regarding the requirements of laser standards (such as test items and labeling requirements). - I want to know about the services provided by UL, estimated costs, required time, and necessary documents/samples, etc.