[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 2: Electromagnetic Interference/EMC Testing for Medical Electrical Equipment (IEC 60601-1-2)

UL Japan

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. Additionally, in recent years, revisions have been made to the EMC standards. In this webinar, as part of the introductory series on safety standards for medical devices in 2025, we will provide an overview of IEC 60601-1-2, explain electromagnetic interference testing, and discuss the changes from the 4th edition to the 4.1 edition. We will also introduce some testing methods for basic standards that were requested in last year's survey.

Date and time Tuesday, Mar 25, 2025
02:00 PM ～ 02:45 PM
The webinar end time is based on the information available at the time this application page was published. Please be aware that it may change.
Capital
Entry fee Free

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[Free Online Seminar] Electromagnetic Interference/EMC Testing of Medical Electrical Equipment
We will explain an overview of IEC 60601-1-2, including electromagnetic interference testing and changes from the 4th edition to the 4.1 edition.

For details and applications, please check the link above or contact us.
Medical Device EMC Testing Services
Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.

The conformity of medical devices to EMC has recently become a significant issue, as it can pose a threat to life. If a product does not conform to the intended environment, it becomes difficult to ensure safety compliance and to achieve its intended effects. EMC testing evaluates the potential for interference between nearby products and the risk of injury or damage to people and the surrounding environment. Additionally, these tests assess the compatibility of devices under the intended electromagnetic environment. In many countries, EMC, radio, and radio frequency (RF) exposure and safety requirements are established. For medical products, several standards are set regarding testing, risk management, basic safety, and essential performance. For example, medical devices sold in the United States must comply with IEC 60601-1-2, 4th edition. The IEC 60601-1-2, 4th edition defines the fundamental safety and essential performance of medical devices concerning radiation and immunity to electromagnetic interference. As of the latest information, the U.S. Food and Drug Administration (FDA) has recognized the 4.1 edition as a Recognized Consensus Standard in December 2023.
EMC/Wireless Testing
One-stop service for on-site measurements, requests, and compliance with radio laws in various countries.

【Testing Facilities】 - Kashima EMC Testing Facility - Shonan EMC Testing Facility - Ise Headquarters EMC Testing Facility (+ Large Mobility Testing Building) - Yokowa EMC Testing Facility - Automotive Technology Center To meet the diverse needs of different products, UL Solutions offers testing through the following methods. We will propose options tailored to our internal resources and the characteristics of the products. ■ Commissioned Testing (Outsourced Testing) Customers provide their products, and our engineers conduct the testing. Since we handle all processes in-house, we can reduce the burden on our customers. ■ Witness Testing Similar to commissioned testing, our engineers perform the tests. Customers can be present during the testing process. ■ On-Site Testing For products that are difficult to transport to the testing facility, such as large equipment, our engineers will visit the factory or installation site directly to conduct the tests. *For more details, please refer to the PDF document or feel free to contact us.
Testing and evaluation services related to medical devices
Providing solutions for the global market.

■ Product safety standards evaluation, testing, and certification services ■ EMC testing services ■ Software evaluation services ■ Cybersecurity testing services for medical devices ■ Biological evaluation and biocompatibility testing services ■ ISO 13485 quality management system audit and registration services
Medical device product safety standards evaluation, testing, and certification services.
Compliance with IEC 60601, IEC 61010, and various individual standards.

■ Technical consultation ■ Structural evaluation services ■ Contracted business testing ■ Testing laboratory accreditation ■ EMC testing and wireless standard testing ■ Radio wave regulations in various countries
Biological evaluation and biocompatibility testing services
In addition to the ISO 10993 series, it is possible to comply with FDA guidance, Ministry of Health, Labour and Welfare guidelines, and the United States Pharmacopeia (USP).

■ Biological evaluation plan and report (including toxicity evaluation) ■ Biocompatibility testing (ISO 10993/USP87, USP88) ■ Chemical analysis testing (ISO 10993-18) ■ Biocompatibility evaluation of respiratory gas pathways (ISO 18562) ■ Validation of cleaning and disinfection processes (ISO 17664-1 and -2, ISO 15883-5, ANSI/AAMI ST98 (US), etc.) ■ Validation of sterilization processes (steam sterilization) (ISO 17665-1) ■ Aseptic barrier systems and packaging systems (ISO 11607-1) ■ Peel testing (EN 868-5), burst testing (ASTM F 2054/F2054M-13), bubble testing (ASTM F 2096-11) ■ Air permeability testing and microbiological airtightness testing ■ Transportation testing and quality control of packaging materials ■ Packaging validation (ISO 11607-2)