[Complete 6 Sessions Introductory Series Seminar] Session 4: Introduction to Testing and Evaluation Standards for Medical Devices – Electrical Safety Testing (IEC 60601-1 Edition 3.2)
UL Japan
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.
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Date and time Tuesday, Jul 11, 2023
02:00 PM ～ 02:55 PM
- Entry fee Free
