[Seminar] Session 2: Introduction to Testing and Evaluation Standards for Medical Devices - 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.
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【Target Audience】 ■ Personnel in charge of regulatory affairs, quality control, and development at medical device manufacturers ■ Those who want to confirm the basic aspects of IEC 60601-1-2 ■ Those who are having trouble with the content of documents such as test plans *For more details, please refer to the related links or feel free to contact us.
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**Overview of UL** UL addresses challenges in safety, security, and sustainability through the application of science, contributing to the creation of a better world. By enabling the safe introduction of advanced products and technologies, UL enhances trust. The staff at UL share a passion for making the world a safer place. From third-party research to standards development, testing, certification, and the provision of analysis/digital solutions, UL aims to build a healthier global society through its operations. The trust in UL supports smart decisions made by businesses, manufacturers, government authorities, regulatory agencies, and individuals. For more details, please refer to the website (UL.com). **Overview of UL Japan, Inc.** UL Japan, Inc. was established in 2003 as the Japanese subsidiary of UL, a global third-party safety science organization. Currently, leveraging UL's global network, it provides conformity assessment services for certification marks required for products in the North American UL mark, as well as safety and EMC certification PSE and S marks based on Japan's Electrical Appliance and Material Safety Law, and certification marks needed for the European and Chinese markets.