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[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 3: Reprocessing Validation of Medical Devices (ISO 17664)
In diagnosis and treatment, many medical devices come into contact with the human body of patients. This can include contact with healthy skin, as well as contact with wounds or circulating blood and …
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Automotive Technology Center Expansion! Invitation to the RVC Open House (Viewing Event)
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."
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UL Solutions expands Automotive Technology Center - Establishes new Reverberation Chamber (RVC) to provide testing that simulates real electromagnetic environments.
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.
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Q&A about SABS certification
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.
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[On-Demand Seminar] Biocompatibility Series of Medical Devices Biological Evaluation of Breathing Gas Pathways (ISO18562 / ISO10993)
In the biological evaluation of medical devices, compliance with the ISO 10993 (Biological evaluation of medical devices) standard is required. Additionally, for medical devices with breathing gas pathways, the application of the ISO 18562 (Biocompatibility evaluation of breathing gas pathways in healthcare applications) standard is also necessary. This seminar will explain the relationship between the ISO 10993 and ISO 18562 standards, and will provide examples of specific medical devices to illustrate the application of these standards.
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[Online Seminar] Overview of Power Variation Test Standards for On-Board Equipment Installed in Electric Vehicles (ISO 21780:2020, ISO 21498-2:2021)
In recent years, automobile manufacturers have been promoting hybrid and electrification, increasing the voltage necessary for electrification to high voltage. Consequently, the importance of resistance to voltage fluctuations in onboard devices operating at high voltage has grown. The requirement standard for electrical and electronic components in vehicles equipped with an electric system (mild hybrid system) operating at 48 V DC, ISO 21780: 2020, was issued in August 2020, and the requirement standard for electrical and electronic components in vehicles equipped with an electric system (full hybrid system, electric system only) operating at 60 V DC or higher (voltage class B), ISO 21498-2: 2021, was issued in March 2021. This seminar will explain the power fluctuation standards for onboard devices necessary for hybrid and electrification in automobiles, specifically the outlines and testing methods of the standards "ISO 21780" and "ISO 21498-2." Please use this opportunity to gather information on the standards.
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EMC/Wireless Standards and Regulations Related News (May 17, 2022)
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's expertise in global regulations to facilitate rapid entry into target markets and ensure ongoing market access. <Summary> - EU | EMC Directive / Machinery Directive / Low Voltage Directive / Medical Device Related Harmonized Standards, UK Harmonized Standards Updates, Committee Letters - United States | KDB Updates, Receiver Immunity Requirements - Canada | ICES-004, RSS-248, 6 GHz Band - Japan | 6 GHz Band, Ku Band, 2.3 GHz Band - Various Standards | EN, ETSI For more details, please check the links in the 'Related Links' section below.
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[Online Seminar] Key Points and Latest Trends in Radio Law Applications in the Asia Region + Latest Information on Major Regulatory Changes in Other Countries
When shipping wireless-equipped products to Asian countries and regions, it is necessary to meet the regulatory requirements of each country. These requirements vary significantly due to the different radio wave regulations in each country, and in recent years, there have been changes in regulations and revisions to the application processes. In this seminar, we will focus on the major Asian countries and regions of high interest to you, based on our application and research achievements across 200 countries/regions. We will explain the application procedures for radio wave laws, points to note during the application, the latest trends based on recent research results, and regulatory information. We hope this will be helpful for organizing information. Please check the detailed agenda and registration through the related materials (PDF) or the registration URL.
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EMC/Wireless Standards and Regulations Related News (April 12, 2022)
It is important, and 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, Australia, New Zealand, and other international standards. Utilize UL's expertise in global regulations to facilitate rapid entry into target markets and ensure ongoing market presence. <Summary> EU | Low Voltage Directive harmonized standards, RE Directive harmonized standards, common charger United States | KDB updates, FCC 22-3, FCC 22-6 Canada | 5.8 GHz band, above 95 GHz, Citizen Band, exposure calculation modeling, RSS-119, RSS-HAC Japan | 6 GHz band, spatial wireless power transmission, 5.2 GHz band, 920 MHz band Australia/New Zealand | 6 GHz band Various standards | ERC, ETSI, CISPR, ECC, IEC For more details, please check the links in the 'Related Links' section below.
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[Online Seminar] Explanation and Latest Information on SABS EMC Certification by the South African Bureau of Standards (SABS)
In the SABS (South African Bureau of Standards) certification system that began implementation in 2017, the submission of EMC test reports issued by SABS-accredited laboratories and the acquisition of certification are required. In this seminar, we will invite Mr. Lawrence Sibeko from SABS to explain the overview of SABS certification, which is essential for exporting not only general electrical and electronic products but also construction machinery, agricultural machinery, etc., to the Republic of South Africa. He will cover the target products, the validity period of the certification, points to note during the application process, penalties, and more. For detailed content, agenda, and registration, please refer to the link below.
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Safety evaluation service for electric disinfectors with germicidal lamps.
Regarding "electric disinfectors" equipped with germicidal lamps, the interpretation of technical standards (Appendix Table 8) and the interpretation of the scope of electrical appliances under the Electrical Appliance and Material Safety Law have been revised (Revised and enforced: December 28, 2021). As a result of this revision, it has been clarified that "electric disinfectors" are subject to the regulations of the Electrical Appliance and Material Safety Law not only for those that emit germicidal light solely within the device but also for those that emit light outside the device. Businesses that manufacture or import relevant products need to confirm compliance with the technical standards. The revised interpretation of technical standards (Appendix Table 8) requires consideration of the photobiological safety of electric disinfectors. UL provides services to support the confirmation of compliance with technical standards based on these interpretations. For more details, please check the "Related Links" below.
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Notice regarding the enforcement of testing and certification of telecom equipment in India (MTCTE).
The Telecommunication Engineering Centre (TEC), the technical division of the Department of Telecommunications (DoT) in India, announced on September 22, 2021, the start dates for Phase III and Phase IV of the Mandatory Testing and Certification of Telecommunication Equipment (MTCTE). Phase III and Phase IV of MTCTE will cover a wide range of products and are expected to be mandatory from July 1, 2022. For details on the target categories, mandatory requirements, and changes planned for 2022, please check the "Related Links."
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EMC/Wireless Standards and Regulations News (February 2022)
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's expertise in global regulations to facilitate rapid entry into target markets and ensure ongoing market participation. <Summary> ● EU | Vehicle-mounted wireless devices, (EU)2022/172, (EU)2022/173, (EU)2022/179, (EU)2022/180, RE directive authorities ● US | New standard application, white space, KDB ● Canada | CS-03, RSS-170, RSS-139 ● Japan | 920 MHz band, 76 GHz band, 2.3 GHz, CISPR ● Standard | ETSI, ECO, EN, ECC, IEC **You can download more details from the "Related Links"**
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[Free Technical Consultation] Technical Consultation on Compliance with Light Radiation Safety Standards for Laser and LED Products
In recent years, products using lasers and LEDs have been on the rise. Various products such as laser projectors, laser lighting, LiDAR/Time-of-Flight (TOF) sensors, head-up displays (HUD), 3D printers, and UV-C related products for Covid-19 measures have been adopted, and we have received many inquiries from our customers regarding evaluations. UL is pleased to announce that we will hold an online technical consultation session regarding compliance with light radiation safety standards for laser and LED-equipped products in response to customer requests. Experienced evaluation engineers from UL, a globally recognized third-party safety science organization, will be available to answer inquiries and questions from manufacturers developing related products. Typically, technical consultations are charged, but during this campaign period, they will be available for free, so we encourage you to take advantage of this opportunity. For examples of consultations and details about the free technical consultation session, please check the "Details & Application" link below.
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【Limited to the first 15 companies】Free technical consultation on safety standards (60601, 61010) for medical devices, in vitro diagnostic devices, laboratory equipment, and testing/measurement instruments.
We will hold a free technical consultation session regarding the application and evaluation of safety standards for medical devices, in vitro diagnostic devices, laboratory equipment, and testing and measurement instruments. If you would like to confirm the applicable standards for your product under development before making a request for evaluation, check whether your product design complies with the applicable standards, or seek advice on necessary safety standards for new development, or request the latest trends and explanations of standards such as 61010-1/60601-1, please feel free to consult with us. We encourage you to take advantage of this opportunity. For examples of consultations, applicable standards, and details of the free technical consultation session, please check the "Details and Application" below.
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EMC/Wireless Standards and Regulations Related News (January 2022)
This document provides the latest standards and regulatory information regarding EMC/Wireless for the United States, Canada, Europe, Australia, New Zealand, Japan, and other international standards. Utilize UL's expertise in global regulations to facilitate rapid entry into target markets and ensure ongoing market presence. <Summary> ●EU | Market surveillance, medical device regulations, low voltage directive harmonized standards, vehicle regulations, medical device harmonized standards, RE directive delegated acts, TGN30 ●US | KDB ●Canada | RSS-248, SPR-APD, GL-01, Notice 2021-DRS0012, SPR-002, Notice 2020-DRS0014, frequency allocation ●Japan | 5.2 GHz band, CISPR, 2.3 GHz band, Electrical Appliance and Material Safety Law, wireless power transmission, 5 GHz band radar, etc. ●Australia/New Zealand | LIPD, EMC ●Standard | ETSI, IEC, EN, AS/NZS, ECC, CISPR **For more details, please refer to the "Related Catalog" below.**
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[Notice] We have started certification testing services for devices equipped with the core technology of next-generation communication, Time Averaged SAR (TAS) functionality.
UL, a third-party safety science organization in the United States, provides regulatory compliance testing and certification support for wireless communication devices and other products not only in Japan but also in countries around the world. As part of this business, we have launched certification testing services for next-generation communication core technology, specifically for models equipped with Time Average Power Control (TAS), at our headquarters EMC testing laboratory in Ise City, Mie Prefecture. With the increasing number of products equipped with TAS to comply with human exposure standards for evolving communication technologies, this technology, also known as time-averaged power control, reduces the average output of radio waves by varying the transmission state without compromising communication quality. Compliance testing for radio wave regulations in various countries for products equipped with TAS could not be conducted with conventional measurement equipment; however, we have now introduced new testing facilities capable of measuring TAS-equipped devices and have commenced certification testing services for these models. In addition to existing radio wave utilization equipment, we will provide regulatory compliance testing services for radio wave utilization devices, including those equipped with TAS, and will continue to expand our certification coverage to North America (FCC, ISED), Europe (CE Marking), Japan (Radio Law), and beyond.
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SEMI F47 Test
The SEMI F47 (Voltage Sag Immunity) test is one of the standards established by the Semiconductor Equipment and Materials Institute (SEMI), which consists of members from the semiconductor and related industries. It simulates a sudden voltage drop in the AC power supply within a semiconductor factory and evaluates the resistance of the tested equipment under such conditions. SEMI: Semiconductor Equipment and Materials Institute Voltage Sag Immunity: Voltage Sag Immunity Our company offers SEMI F47 (Voltage Sag Immunity) testing services for semiconductor process equipment. For details and quotes, please check the "Related Links" below.
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[On-Demand Seminar] The Electromagnetic Wave/EMC Environment Surrounding Cars
Free, Limited Time Only In the United States and Europe, emissions regulations and fuel efficiency regulations have begun, and the electrification of vehicles continues to accelerate. In the near future, it is expected that the share of new electric vehicle (xEV) sales worldwide will surpass that of gasoline vehicles. As "electrification" and "connectivity" advance, automobiles, often referred to as moving computers, may experience significant accidents if electromagnetic noise emitted by onboard components causes electromagnetic interference between them. The importance of EMC (Electromagnetic Compatibility) testing is increasing to prevent accidents caused by electromagnetic noise and interference. Furthermore, electric vehicles are equipped with many wireless technologies similar to smartphones, such as Bluetooth, Wireless LAN, 4G, and 5G, necessitating compliance with radio laws in various countries. The requirements of these radio laws and the documentation needed for regulatory applications vary by country, and violations may result in penalties. This seminar will explain the regulations and requirements regarding the radio/EMC environment surrounding vehicles.
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[Online Seminar] Biological Evaluation Process of Medical Devices for Breathing Gas Pathways (ISO 18562)
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
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[Online Event] Announcement of UL Seminar 2021 <11/12 - 12/3>
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.
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【NEWS】India BIS | CRO Phase V mandatory items (digital cameras, video cameras, etc.) will be enforced starting October 1, 2021.
According to the regulations of the Ministry of Electronics and Information Technology (MeitY), the additional Phase V mandatory items (wireless microphones, digital cameras, video cameras, webcams, smart speakers, Bluetooth speakers, and dimmers for LED products) will require registration with the Bureau of Indian Standards (BIS) before being exported or sold in India starting from October 1, 2021. This also includes cameras used in automobiles (such as dash cameras, rear cameras, distance cameras, and surround cameras). UL will provide testing and report issuance services through UL India, which is a BIS accredited testing laboratory.
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[Event] Notice of Online Exhibition at Automotive World
UL will participate in the online exhibition "1st Automotive World Online" to be held from September 8 (Wednesday) to 10 (Friday), 2021. Our company established the Automotive Technology Center (ATC), an EMC-related testing facility for automotive equipment, in Miyoshi City, Aichi Prefecture in June 2017. In April 2019, we set up a "Reliability Testing Lab" specialized in environmental and durability testing for automotive components, which was expanded in September 2020. In January 2020, we established a "Next-Generation Mobility Building" at the Kashima EMC Testing Facility in Katori City, Chiba Prefecture, and in July 2020, we built an EMC testing facility for large equipment such as construction machinery, called the "Large Mobility Testing Building," within our headquarters in Ise. In January 2021, we introduced new testing equipment capable of handling high-capacity batteries for applications such as e-mobility, striving to expand our testing capabilities in the automotive and mobility-related fields. At this exhibition, the UL booth will showcase a wide range of services related to mobility, including "Automotive EMC/Wireless Testing," "EMC Testing for Large Equipment such as Construction Machinery," "Reliability Testing," and "Battery Safety Testing."
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Mexico Official Standards Application Response Seminar: NOM-001-SCFI-2018, NOM-019-SCFI-1998
【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.
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Biological Evaluation Plan (BEP) - Key Points for Developing a Biological Evaluation Plan
【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.
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About the Brazil (ANATEL) Radio Wave Law Certification Process - Security Requirements Required After July 2021
[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.
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Overview of EMC standards for earthmoving and construction machinery, in conjunction with JIS standardization (JIS A 8316-1/-2)
[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
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Brazil: Additional Cybersecurity Requirements for Telecommunications Equipment
On January 5, 2021, Brazil's ANATEL issued Act No. 77, which added cybersecurity requirements for telecommunications equipment (composed of approximately 40 security requirements). From July 4, 2021, for telecommunications equipment connected to the internet or communication lines, the submission of a declaration regarding cybersecurity will be required as part of the application documents for certification. Applicants must submit this declaration to demonstrate that their products meet security requirements and that appropriate measures against vulnerabilities are in place. UL provides services to comply with these cybersecurity requirements and will support your application to Brazil.
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EN ISO 13766-1,2:2018 enforcement begins.
The latest EMC standards for construction machinery, EN ISO 13766-1, 2:2018, will become mandatory from July 1, 2021. In the EU, compliance with EU harmonization legislation and the display of CE marking on construction machinery being marketed is required. The harmonized standard for the 2014/30 EU EMC Directive, "EN 13309:2010," will be withdrawn, and the latest standard, "EN ISO 13766-1,2:2018," will be enforced. This enforcement will expand the upper frequency limits for radiated immunity required by EMC and will newly require radio wave irradiation for the construction machinery itself. Additionally, not only in the EU but also in South Africa, EMC testing for finished construction machinery is stipulated as a requirement. UL has a large electromagnetic compatibility (EMC) chamber capable of handling large equipment, such as construction machinery weighing up to 100 tons, and can provide EMC services in accordance with "EN ISO 13766-1,2:2018."
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UL has newly introduced testing facilities capable of handling high-capacity batteries in Ise City.
UL has made advancements in high-capacity and high-energy density batteries, expanding their applications to e-mobility products such as electric assist bicycles, and contributing to the improvement of safety for these batteries and related products. On April 8, 2021, UL implemented capital investments, including two medium-sized explosion-proof chambers for testing high-capacity batteries at its headquarters in Ise City, Mie Prefecture, and launched comprehensive testing and certification services, including customized testing and reliability testing. In addition to the battery certification services for consumer products that UL has been providing at its Japan location, it will now also be able to handle testing and certification for high-energy density and high-capacity batteries.
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[On-Demand Seminar] A Must-See for Finished Product Manufacturers! About Solder Limits and Thermal Stress Testing of Printed Circuit Boards
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.