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The Health Sciences Wire - Issue 11

While the leaves continue to fall, the November issue is here

Newsletter banner 11

November 3, 2020

Amendment 2 of IEC 60601-1

Part 2 in our series of Amendment 2 of the IEC 60601-1 standard looks at the key points in ISO 14971:2019 3rd edition, which provides guidance for the application of risk management for medical devices, as well as information on regulatory compliance timelines.

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Breathalyzer Technologies for Coronavirus Detection

We examine the application of breathalyzer technologies traditionally used for blood alcohol content (BAC) for the detection of coronavirus and other infections.

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Robots for Surgical Assistance

With the benefits of robotically assisted surgical procedures, more medical manufacturers are producing surgical assist robots for multiple purposes. Understand the potential risks associated with these products and the IEC standard that addresses the basic safety and essential performance requirement for surgical-assist robots.

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Power Supply Corner - Part 3: IECEE CB Scheme Updates

This is the third installment in our four-part series on power supply testing and certification. UL experts will summarize updates related to the IECEE CB Scheme for Medical Power Supplies and how the scheme will benefit manufacturers and distributors with international involvements.

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Part 2: Are you ready for your testing and certification process?

Following the first installment, this is our second installment of “Are you ready for your testing and certification process?” This month, we will look at the five key items that you can start preparing now to get your project started on the right path. 

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Recorded Webinar: How to Prepare for 5G Regulatory Compliance

Gain insight into 5G frequency compliance requirements, testing methods and system performance needs, including the ones for over the air (OTA), electromagnetic compatibility (EMC), interoperability, batteries and chipsets.

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