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The Health Sciences Wire - Issue 03

On a monthly basis, we’ll be providing news, insights and analysis on safety testing, inspection and certification issues affecting medical device and healthcare technology developers. This month’s issue will look at UL’s project management services; tips and tricks for UL Follow-Up services; new advances in infusion pump testing equipment; and infusion pump testing to standards.

The Health Sciences Wire - Issue 03

March 5, 2020

EMC Lab

News: UL Fremont EMC now has IEC 60601-1-2 4th edition in their CB scope

The 178,900 square foot facility offers a seamless end-to-end service solution

UL’s Fremont, CA facility has been granted a scope expansion on numerous standards by the NCB; in particular IEC 60601-1-2 ed. 4. As the IECEE is currently updating their site, more information on this exciting news will follow in coming issues.

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Project Management

Project Management for a Cohesive Experience

How project management services can improve the safety and regulatory testing

There are distinct advantages to having all of your product services met by a single provider. The coordination of multiple project engineers, testing performed in more than one laboratory location, multiple project start and end dates, multiple sample and documentation requests can all be handled through one source.

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Electroencephalographs

Alert: New Edition of IEC 80601 -2-26 for Electroencephalograph

Newly published requirements for the safety and performance of electroencephalographs

The new edition of IEC 80601-2-26 applies to the basic safety and essential performance of electroencephalographs. This document is applicable to electroencephalographs used in healthcare facilities, the emergency services or the home healthcare. UL's experts have already received the changes and can assist with electroencephalographs testing and compliance to the new edition of the IEC 80601-2-26 standard. For more information on the new standard and how it affects your operation, contact us and we will be happy to assist.

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Infusion Pump

Specialized Infusion Pump Testing Equipment

Some of the special infusion pump and testing capabilities at the Minnesota facility

Experts, Seth De Sota and Benjamin Dahlen discuss infusion pump testing and the specialized instrumentation required for accurate results. They also take a look at a specific instance that required them to explore how external factors can unexpectedly alter results.

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Infusion Pump

Infusion Pump Testing to IEC 60601-2-24

Infusion pumps used for critical care, emergency care, and long- and short-term disease maintenance

This white paper examines the specialized test equipment needed to conduct the IEC 60601-2-24:2012 to reduce vibration and other environmental conditions that interfere with test results and how manufacturers can use these test reports as part of their applications for regulatory approvals around the world.

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Follow-Up Services

Avoid Post UL Mark Process Delays: Get to Know UL Follow-Up Services (FUS)

UL Follow-Up services are an important part of the UL Mark process. Learn how to avoid delays during the process, or even after the process has been completed, by understanding what is required during the follow-up visits.

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